Phase 2 clinical trial. Medical search. Frequent questions

The company's lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. (geovax.com)
This prospective, randomized, double-blinded, vehicle- and placebo-controlled, multicenter clinical study is designed to evaluate the safety and efficacy of IDCT in patients with symptomatic, single-level, mild to moderate lumbar DDD. (businessinsider.com)
The ST EADFAST study is a multicenter, open-label, single ascending dose, dose-ranging Phase 1/2 study. (sangamo.com)
The oral presentation entitled Initial Results from a Phase 1/2 Trial of Large Surface Area Microparticle Docetaxel for High-Risk Non-Muscle Invasive Bladder highlighted safety and preliminary efficacy data from the multicenter dose-rising/confirmation clinical trial that enrolled 19 subjects. (crititech.com)
In patients with treatment-resistant hypertension on stable doses of at least 3 antihypertensive agents, baxdrostat, a selective aldosterone synthase inhibitor, was associated with dose-related reductions in blood pressure (BP) with no impact on cortisol levels, according to findings from a multicenter, placebo-controlled phase 2 dose-ranging trial. (patientcareonline.com)
Corbus Pharmaceuticals announced the addition of a protocol amendment to one of the company's existing Investigational New Drug (IND) Applications with the FDA for a Phase 2 clinical trial of Resunab for the treatment of systemic lupus erythematosus (SLE), an important step to initiate a multicenter placebo-controlled SLE trial. (lupusnewstoday.com)

European trials are planned to start in 2019. (maps.org)
BRISBANE, Calif. --(BUSINESS WIRE)--Nov. 19, 2019-- Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, announced today that the United Kingdom's ( UK ) Medicines Healthcare Products Regulatory Agency (MHRA) has granted authorization of the first-in-human clinical trial to evaluate a Chimeric Antigen Receptor Regulatory T Cell (CAR-Treg) therapy. (sangamo.com)
The results of the exploratory phase IIA trial, the KHENERGY study, were published in 2019. (wikipedia.org)
June 1, 2019: Kymab, a clinical-stage biopharmaceutical company developing antibody-based therapeutics, today announced a poster presentation detailing updates on the ongoing clinical trial of the company's anti-ICOS program KY1044 at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting. (malinplc.com)

At the European Hematology Association 2022 Hybrid Congress, Gracell presented longer-term follow-up clinical data of GC012F in RRMM that showed a 100% minimal residual disease (MRD) negativity rate in all patients treated. (biospace.com)
PTC Therapeutics, Inc. announced on 31st March 2022 the initiation of the PIVOT-HD Phase 2 clinical trial evaluating PTC518 in people with Huntington's disease (HD). (acnr.co.uk)

SEATTLE, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer, today announced that it has reached full enrollment in the Company's Karisma-Endoxifen clinical trial, the 240-person Phase 2 study investigating (Z)-endoxifen in premenopausal women with measurable mammographic breast density (MBD). (khon2.com)
Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. (biospace.com)
Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in multiple diseases. (einpresswire.com)
Nuvalent, Inc. (Nasdaq: NUVL) is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer, designed to overcome the limitations of existing therapies for clinically proven kinase targets. (wjbf.com)
SALT LAKE CITY , March 4, 2020 /PRNewswire/ -- DiscGenics, Inc., a clinical stage biopharmaceutical company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, today announced that it has completed enrollment in its Phase 1/2 first-in-human U.S. clinical study of IDCT, an allogeneic, injectable Discogenic Cell therapy for degenerative disc disease (DDD). (businessinsider.com)
First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. (microcaps.com)
Novel drug candidate, MRX-I, an oral oxazolidinone showed positive top-line results from the first Phase 2 clinical study in China, according to biopharmaceutical company, MicuRx Pharmaceuticals , Inc. today. (outbreaknewstoday.com)

Additionally, based on the original protocol, if ≥3 of the planned 10 patients within the pilot phase experienced a partial response (PR) by RECIST criteria within 16 weeks, the combination would be considered promising and an expansion cohort of an additional 30 patients would be initiated for enrollment. (kron4.com)
Earlier this year, following a review of the pilot phase data, the trial was amended to become a randomized study, with planned enrollment increasing from 30 to 102 patients. (kron4.com)
MacroGenics, Inc. and Eli Lilly and Company (NYSE: LLY) today announced that the PROTEGE trial achieved its targeted patient enrollment. (science20.com)
Company Completes Enrollment for Phase 2 Trial of "Immune Resetting" Peptide. (snacksafely.com)
A step closer to dental caries prevention: Successful completion of phase 1 clinical study enrollment for C16G2 The clinical protocol is a randomized, double-blind, placebo-controlled, four arm, safety and microbiology study in healthy adult subjects. (perioimplantadvisory.com)
This two-arm, adaptive-design trial is targeting enrollment of up to approximately 550 participants across approximately 35 clinical sites. (tonixpharma.com)

Gracell plans to initiate a Phase 1/2, single-arm, open-label, multi-center trial in China in the third quarter of 2023 to further evaluate GC012F in RRMM patients. (biospace.com)
Following the U.S. FDA's clearance of Gracell's IND application announced on Feb. 3 , Gracell also plans to initiate a Phase 1b /2 clinical trial in the U.S. in the second quarter of 2023. (biospace.com)
A poster of the amended clinical trial design was presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 2-6 in Chicago, Illinois (see abstract ). (kron4.com)
Atlanta, GA, February 15, 2023 - GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, and EmVenio Research, a patient-focused decentralized trial global organization, today announced a collaboration to deploy a mobile clinical facility in the Claremont, California area to expand GeoVax's ongoing Phase 2 clinical trial evaluating GEO-CM04S1 as a COVID-19 booster vaccine in healthy patients. (geovax.com)
ORSERDU (elacestrant), 345 mg tablets, was approved in January 2023 for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1 -mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. (ntb.no)
First Wave BioPharma anticipates conducting the End-of-Phase 2 meeting in the fourth quarter of 2023. (microcaps.com)

This study's goal is to expand upon the successful results attained with WF10 in our first Phase 2 allergic rhinitis study. (newswire.ca)
Having now completed enrolment in our second larger multi-center Phase 2 study, we move closer to generating further evidence of WF10's potential benefit for allergy sufferers whose disease is not adequately controlled with existing therapies. (newswire.ca)
The 16-week trial is a randomized, double-blind, placebo-controlled study to assess the efficacy, safety and tolerability of a regimen of five infusions of either WF10 or its main constituents (sodium chlorite and sodium chlorate) relative to saline control in patients with multiple airborne allergies who suffer from moderate to severe allergic rhinitis. (newswire.ca)
We are excited that the Karisma-Endoxifen study is fully enrolled and look forward to seeing data from the trial in the second half of 2024," said Dr. Steven Quay, Atossa's President and Chief Executive Officer. (khon2.com)
This phase 2 trial was a 24-week randomized, placebo-controlled, two-way crossover study in 30 adult male patients (age 18-41 years) with FXS. (nature.com)
All requests for raw and analyzed data will be promptly reviewed by the study sponsor, Tetra Therapeutics, and by the clinical site, Rush University Medical Center, to verify if the request is subject to any intellectual property or confidentiality obligations. (nature.com)
Gracell is committed to developing innovative cell therapies to transform patients' lives, and we look forward to launching the Phase 1/2 IND trial in China to further study GC012F. (biospace.com)
Atossa's (Z)-endoxifen has been shown to be well tolerated in Phase 1 studies and in a small Phase 2 study of women with breast cancer. (wjtv.com)
Z)-endoxifen is currently being studied in four Phase 2 trials: one in healthy women with measurable breast density, one in women diagnosed with ductal carcinoma in situ, and two other studies including the EVANGELINE study in women with ER+/HER2- breast cancer. (wjtv.com)
In the PIVOT-HD trial, we aim to confirm the dose-dependent lowering of huntingtin protein that was demonstrated in our Phase 1 clinical study and gain insight to biomarker data that could provide meaningful evidence of treatment effect. (acnr.co.uk)
In a Phase 1 healthy volunteer study of PTC518 for Huntington's disease, PTC518 demonstrated a dose-dependent lowering of HTT mRNA and protein to the targeted 30-50% reduction. (acnr.co.uk)
Cellceutix's anti-cancer drug Kevetrin is concluding a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and Cellceutix is now preparing its application for a Phase 2 study. (einpresswire.com)
The nature of the investigation or investigational use for which clinical study information is being submitted. (uclahealth.org)
Participants must meet the following criteria on screening examination to be eligible to participate in the study: Patients must have a confirmed diagnosis of neurofibromatosis 2 by fulfilling National Institute of Health (NIH) criteria or Manchester criteria, or by detection of a causative mutation in the NF2 gene. (uclahealth.org)
To present the study design of ROCCELLA, a large Phase 2 clinical trial in knee OA (KOA) patients, evaluating the efficacy and safety of GLPG1972/S201086 in reducing cartilage loss in OA. (bmj.com)
This is the first large Phase 2 study where patients with primary KOA are treated for 52 weeks with GLPG1972/S201086, an orally administered DMOAD candidate. (bmj.com)
This clinical trial was designed with a combination of two radiological selection criteria to ensure sufficient structural progression (cartilage loss) in the study population. (bmj.com)
The trial is a pivotal Phase 2/3 clinical study evaluating teplizumab, an investigational compound under development for the treatment of individuals with recent-onset type 1 diabetes. (science20.com)
The PROTEGE trial is a randomized, double-blind, multi-center, multi-national, 4-arm, controlled study designed to evaluate the safety and efficacy of teplizumab in individuals with recent-onset type 1 diabetes, aged 8 to 35, who are within 12 weeks of their diagnosis. (science20.com)
Longer term safety and efficacy data from patients who complete the PROTEGE trial are being collected in a separate Phase 3 study called the PROTEGE Extension trial. (science20.com)
The companies also announced today that they have initiated the PROTEGE ENCORE trial, another Phase 3 global study of teplizumab in individuals with recent-onset type 1 diabetes, designed to capture patient-reported outcome measures in addition to safety and efficacy data. (science20.com)
The study will evaluate the effect of ATH434 treatment on neuroimaging and protein biomarkers to demonstrate target engagement and clinical endpoints to demonstrate efficacy, in addition to assessments of safety and pharmacokinetics. (yahoo.com)
Participants will receive treatment for 12 months which will provide an opportunity to detect changes in efficacy endpoints to optimize design of a definitive Phase 3 study. (yahoo.com)
The immunological responses measured throughout the study will include both the level of SARS-CoV-2 neutralizing antibodies and specific T-cell responses. (geovax.com)
By blocking the CXCR4 receptor, motixafortide was shown in a Phase 2 study in pancreatic cancer patients to enhance anti-tumoral activity and to ameliorate the pro-tumoral activities by modulating the effector/suppressor cell ratio towards a proinflammatory profile. (fox5sandiego.com)
Allogeneic mesenchymal stem cells (MSCs) were previously tested in a Phase I/2 proof-of-concept study conducted by investigators at the University of Miami's Miller School of Medicine. (stemcellsportal.com)
In that study, MSCs were shown to be safe and well-tolerated in frail, elderly subjects in a Phase 1 open label single ascending dose trial with a similar safety profile observed in the randomized, placebo-controlled Phase 2 study. (stemcellsportal.com)
Sangamo expects to open the first clinical sites for the ST EADFAST study in 2020. (sangamo.com)
As a phase 2 clinical trial, the purpose of this study was to test whether the compound has therapeutic potential in a small number of patients. (sbpdiscovery.org)
In the dose-rising phase of the study (n=13), 3mg to 15mg of investigational drug were delivered IMI into and around the tumor resection bed post transurethral resection of bladder tumor (TURBT) followed by multiple periodic IVT of 50mg to 75mg. (crititech.com)
Company reports positive topline results from phase 2 study. (snacksafely.com)
Phase 2 study continues to show AQST-109 is safe and well tolerated. (snacksafely.com)
Phase 2 trials can become incredibly complex as sponsors follow the science of their study. (4gclinical.com)
Unlike traditional IRT systems which can be rigid, Prancer RTSM Ⓡ enables the flexibility to increase overall study efficiency and expediting clinical development. (4gclinical.com)
The FOCUS (First-line metastatic Or recurrent HNSCC/Checkpoint inhibitor UV1 Study) Phase II trial is an investigator-sponsored, randomized Phase II clinical trial that will recruit patients with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma. (precisionvaccinations.com)
A total of 75 patients indicated for treatment with pembrolizumab will be enrolled in the FOCUS study, randomized 2-to-1 so that 50 patients will receive UV1 and pembrolizumab, and 25 patients will receive pembrolizumab alone. (precisionvaccinations.com)
This is a phase 2 study to determine 2-HOBA's tolerability, safety, and effect on isoLG-adducts in patients with rheumatoid arthritis (RA) patients. (arthritis.org)
This pilot study will inform the feasibility and design of future studies to examine the efficacy of 2-HOBA in RA patients. (arthritis.org)
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. (arthritis.org)
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. (arthritis.org)
If of childbearing potential, willingness to use effective birth throughout study and 4 weeks after completion of the study (examples: condom, diaphragm, oral contraceptive pill, intrauterine device) - If using non-steroidal anti-inflammatory drugs (NSAIDs), willingness to discontinue use of NSAIDs for 2 weeks prior to the study and throughout the study. (arthritis.org)
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. (arthritis.org)
The person who is responsible for the scientific and technical direction of the entire clinical study. (arthritis.org)
BOTHELL, WA and VANCOUVER - September 22, 2010 - (Canada NewsWire via COMTEX News Network) - Randomized Phase 2 Study of Docetaxel and Prednisone With or Without OGX-011 in Patients With Metastatic Castration-Resistant Prostate Cancer. (higcapital.com)
Because the primary endpoint of the study was achieved and survival benefit was observed, custirsen warrants further study in Phase 3 trials. (higcapital.com)
In this Phase 2 study, 82 patients were randomized to one of two treatment arms to receive either 640 mg per week of custirsen by intravenous infusion in combination with docetaxel/prednisone or docetaxel/prednisone alone. (higcapital.com)
ctDNA analysis performed via liquid biopsy will form a critical component of the study to inform two key questions: (1) the level of benefit in patients without a detectable ESR1-mutation and (2) the patient selection biomarker potential of TP53-mutation status. (ntb.no)
Study participants with blood pressure ≥130/80 mm Hg who were randomized to 2 of 3 different doses of baxdrostat dosed once daily experienced statistically significant placebo-adjusted decreases in systolic blood pressure (SBP) of −11.0 (2-mg) and −8.1 (1-mg) compared to placebo, reported study authors. (patientcareonline.com)
In preclinical and phase 1 studies, baxdrostat has proven highly selective for aldosterone synthase while not affecting the enzyme required for cortisol synthesis, the authors explain, thus setting the stage for the current phase 2 study examining the agent's efficacy and safety in patients with treatment- resistant hypertension. (patientcareonline.com)
Data analysis at 12 weeks found dose-dependent changes in SBP of −20.3 mm Hg, −17.5 mm Hg, −12.1 mm Hg, and −9.4 mm Hg in the 2-mg, 1-mg, and 0.5-mg baxdrostat-treated study groups and the placebo group, respectively. (patientcareonline.com)
The Phase 2 portion of the ongoing Phase 1/2 clinical trial is a randomised, placebo-controlled, observer-blinded study to evaluate the safety and immunogenicity of NVX-CoV2373 with Matrix-M in subjects aged 18 to 84 years. (expresspharma.in)
C3 Jian expects this Phase 2 study to be completed in late 2014. (perioimplantadvisory.com)
The clinical study, expected to begin early in 2017, will be funded by a grant from the National Institutes of Health (NIH) to the Feinstein Institute for Medical Research (FIMR), Manhasset. (lupusnewstoday.com)
Participation in any investigational study within 30 days prior to screening or planning to participate in any other investigational drug or device clinical trials within 30 days of study completion. (ocuphire.com)
The results of ENDEAVOR are very encouraging and will pave the way for a pivotal trial to evaluate the safety, efficacy and effectiveness of MT-7117 as an oral once a day treatment option for EPP" said Robert Desnick, MD PhD, Dean for Genetic and Genomic Medicine, Icahn School of Medicine at Mount Sinai, NY and Lead Investigator on the study. (porphyriafoundation.org)
The Phase 2 SPAN clinical trial was designed to investigate the safety, tolerability and efficacy of an enteric microgranule delivery formulation for adrulipase in a titrated dose-escalation study involving thirteen (13) patients. (microcaps.com)
Mr. Sapirstein added: "We would like to thank the patients who volunteered to participate in the study and the investigators and their staff at our three participating clinical trial sites for ensuring that the trial was fully enrolled and completed on time. (microcaps.com)
This study included a single-center, double-blinded, randomized, placebo-controlled 2-way crossover trial, during which patients received 100 mg Sonlicromanol and placebo in random order, both for 28 days. (wikipedia.org)
KHENEREXT is the follow-up study, which is an open-label, multi-center trial, during which patients receive either 50 or 100 mg of Sonlicromanol twice a day for an entire year to explore the long-term safety and efficacy. (wikipedia.org)
Data from the Phase 2 study of MRX-I reported today combined with prior Phase 1 trial results indicate that this promising agent may offer the efficacy of the oxazolidinone class without bone marrow toxicity. (outbreaknewstoday.com)
This Phase 2 study was funded through MicuRx's joint venture with Shanghai Zhangjiang Biomedical Industry Venture Capital, founded to advance the development of MRX-I for the Chinese market. (outbreaknewstoday.com)
In a Phase 2 study, Tonmya 5.6 mg (2 x 2.8 mg tablets), was found to be effective in treating military-related PTSD, which formed the basis of the Breakthrough Therapy designation granted by the FDA. (tonixpharma.com)
Tonix is currently conducting a Phase 3 trial of Tonmya in military-related PTSD in the United States, the HONOR study, which is a 12-week randomized, double-blind, placebo-controlled trial evaluating the efficacy of Tonmya 5.6 mg in participants with military-related PTSD. (tonixpharma.com)
The poster details the first-in-human clinical study (NCT03829501) of KY1044, Kymab's fully human anti-ICOS IgG1 antibody. (malinplc.com)
This study aimed to evaluate the informed consent process, therapeutic misconception and motivation for participation among Egyptians participating in clinical trials. (who.int)
In a cross-sectional qualitative pilot study 103 participants in 10 clinical trials responded to a questionnaire. (who.int)
Cross-neutralization Capacity of Immune Serum From Different Dosage of Sabin Inactivated Poliovirus Vaccine Immunization Against Multiple Individual Wild and Vaccine-derived Polioviruses, Supplementary Study of a Phase 2 Clinical Trial. (who.int)

NanOlogy, LLC ( www.nanology.us ) is a private clinical-stage interventional oncology drug company formed in 2015 to improve the treatment of solid tumors based on a proprietary particle engineering technology platform for tumor-directed therapy. (crititech.com)

We appreciate the dedication of the patients, their caregivers and clinical investigators who helped advance this important late-stage clinical trial. (science20.com)
In addition to Dr. Kates, contributing clinical investigators were Ahmed Mansour, MD (UT Health San Antonio) , Donald Lamm, MD (BCG Oncology) , and Neal Shore, MD (Carolina Urologic Research Center) . (crititech.com)
Investigators randomized the final cohort to receive to receive baxdrostat (0.5 mg, 1 mg, or 2 mg) once daily for 12 weeks or placebo. (patientcareonline.com)
or the past 2 years, a team of investigators from the Cen- purchased to support administration of the 75 million doses of F ters for Disease Control and Prevention (CDC) has collab- vaccine. (cdc.gov)
Investigators need to emphasize the distinction between research and clinical care to address the high rate of therapeutic misconception. (who.int)

Participants have been randomized to placebo, 1 mg, and 2 mg daily doses of (Z)-endoxifen and will be treated for six months, over the course of which mammograms are conducted to measure reduction in MBD. (khon2.com)
In a pooled Phase 1 safety analysis involving 171 participants GLPG1972/S201086 was shown to be well tolerated. (bmj.com)
Sponsored by the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS), the double-blind, placebo-controlled trials in 103 subjects total found that 54% of participants in the active treatment group (75-125 mg MDMA) did not qualify for a diagnosis of PTSD, compared to 23% in the control group (0-40 mg MDMA). (maps.org)
Trial participants included men and women with chronic, treatment-resistant PTSD from a wide variety of causes. (maps.org)
The first of two Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD began enrolling participants in November 2018, and will enroll 100-150 volunteers across 15 sites in the U.S., Canada, and Israel. (maps.org)
The second trial will take place after an interim analysis of the data from the first trial, and will enroll an additional 100-150 participants. (maps.org)
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. (arthritis.org)
RÉSUMÉ Les études ayant examiné le processus du consentement éclairé chez les participants à des études de recherche dans les pays en développement sont peu nombreuses. (who.int)

NRI ), a specialty pharmaceutical company with a diverse portfolio of topical and immunology products, today announced that it has completed enrolment in its Phase 2 clinical trial to investigate the safety and efficacy of WF10 in patients with refractory allergic rhinitis. (newswire.ca)
Treatment of patients in the WF10 Phase 2 allergic rhinitis clinical trial commenced in March 2014. (newswire.ca)
Phase 2 clinical trials were conducted across multiple centres in India and included over 200 patients which included testing the antidote against the Omicron variant to ensure maximum coverage against the virus and its known mutations. (siasat.com)
In this phase, VINCOV-19 was administered to patients with moderate severity of COVID-19. (siasat.com)
There was a good and early improvement in the clinical condition of the patients administered VINCOV-19. (siasat.com)
In the present report, we evaluated the efficacy of oral Cu supplementation in the treatment of AD in a prospective, randomized, double-blind, placebo-controlled phase 2 clinical trial in patients with mild AD for 12 months. (springer.com)
The first site initiation visit was completed at a clinical site in Austria, where screening for eligible patients will begin shortly. (biospace.com)
The phase 1 trial of Kevetrin trial yielded exciting data validating the safety of Kevetrin and suggestive evidence of the potential clinical benefit of Cellceutix's novel p53-targeting compound in patients who had relapsed after other cancer treatments. (einpresswire.com)
Because of the relatively short half-life of Kevetrin in plasma, it is the Company's belief that administering Kevetrin multiple times per week may have a clinical benefit in the planned Phase 2 trial in patients with ovarian cancer. (einpresswire.com)
Cellceutix is in a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. (einpresswire.com)
Eligible patients were aged 40-75 years with a diagnosis of primary femorotibial KOA, a pain score of 40-90mm on a 100 mm Visual Analogue Scale (VAS), predominant medial disease and a combined Kellgren/Lawrence (KL) 2 or 3 and Osteoarthritis Research Society International (OARSI) medial joint space narrowing (JSN) 1 or 2 severity grading range upon central reading of the X-ray. (bmj.com)
The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled investigation of ATH434 in patients with early-stage MSA. (yahoo.com)
Currently in two Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a COVID-19 vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient. (geovax.com)
In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. (geovax.com)
The presentation marks the first disclosure of data characterizing the safety and clinical activity of NVL-655 from the Phase 1 dose-escalation portion of the ongoing ALKOVE-1 Phase 1/2 clinical trial evaluating NVL-655 in patients with advanced ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors. (wjbf.com)
The ALKOVE-1 clinical trial is continuing to enroll patients in the Phase 1 portion of the trial. (wjbf.com)
NVL-655 is currently being investigated in the ALKOVE-1 clinical trial ( NCT05384626 ), a first-in-human Phase 1/2 clinical trial for patients with advanced ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors. (wjbf.com)
Longeveron LLC, a regenerative medicine company developing cellular therapies, has treated its first patient in a Phase 2b clinical trial evaluating the safety and efficacy of its human allogeneic mesenchymal stem cells (LMSCs) in patients with aging frailty syndrome. (stemcellsportal.com)
Astex Pharmaceuticals, Inc. has announced that it has initiated the Phase 2 dose expansion segment of the clinical trial of SGI-110, a novel hypomethylating agent, in patients with intermediate-2 or high-risk myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML). (technologynetworks.com)
The Phase 2 segment includes expansion of the number of patients to approximately 90 patients treated on the five day subcutaneous dosing schedule to better evaluate both efficacy and safety in MDS and AML patients. (technologynetworks.com)
The allowance of treatment-naive MDS and elderly AML patients will be important in evaluating efficacy and safety of SGI-110 in this patient population and to further characterize the clinical differentiation of the drug," said Mohammad Azab, MD, chief medical officer. (technologynetworks.com)
The drug achieved excellent hypomethylation, and major clinical responses in heavily pre-treated AML patients were observed. (technologynetworks.com)
In a phase 2 clinical trial conducted by Avalo and supported by Sanford Burnham Prebys, a significantly higher proportion of hospitalized patients with COVID-19 remained alive and free of respiratory failure for 28 days after receiving treatment with the new antibody, called CERC-002. (sbpdiscovery.org)
All patients were hospitalized with mild-to-moderate respiratory distress and were also receiving standard-of-care therapy during the trial. (sbpdiscovery.org)
Non UK patients can find trial location information on clinicaltrials.gov. (mpgnddd.org)
A Phase II randomized clinical trial will evaluate a proprietary universal cancer vaccine, UV1, in patients with recurrent or metastatic head and neck cancer who will be treated with standard of care therapy pembrolizumab. (precisionvaccinations.com)
To date, UV1 has been tested in four phase I clinical trials in a total of 82 patients and maintained a favorable safety and tolerability profile as well as encouraging signals of efficacy. (precisionvaccinations.com)
I am excited to apply my insights as well as my team's expertise to this trial to potentially provide head and neck cancer patients with better treatment options. (precisionvaccinations.com)
The clinical development of the UV1 vaccine includes four randomized, multinational, Phase II combination trials recruiting more than 450 patients in total. (precisionvaccinations.com)
The INITIUM trial is an Ultimovacs-sponsored clinical trial recruiting 154 patients with metastatic malignant melanoma to evaluate UV1 combined with ipilimumab and nivolumab as first-line treatment. (precisionvaccinations.com)
The fourth trial, FOCUS, is an investigator-sponsored, randomized clinical trial, enrolling 75 patients with metastatic head and neck cancer receiving pembrolizumab as the standard of care to evaluate its impact, adding UV1 to this regimen. (precisionvaccinations.com)
The trial results showed a survival benefit with the investigational agent OGX-011/TV1011 (custirsen) in patients with advanced prostate cancer. (higcapital.com)
The primary endpoint of the trial was to achieve a 50% reduction in PSA from baseline in over 50% of the patients treated with custirsen plus docetaxel. (higcapital.com)
Mitsubishi Tanabe Pharma Development America, Inc. today announced successful completion of the Phase 2 clinical trial of MT-7117, an investigational oral treatment under development for the prevention of phototoxicity (including severe pain on exposure to sunlight) in patients with Erythropoietic Protoporphyria (EPP). (porphyriafoundation.org)
First Wave is advancing two Phase 2 clinical programs built around adrulipase for the treatment of exocrine pancreatic insufficiency (FW-EPI) in patients with cystic fibrosis (CF) and chronic pancreatitis (CP). (microcaps.com)
Safety of Ipragliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Phase II/III/IV Clinical Trials. (bvsalud.org)
Safety data from 12 randomised, phase II/III/IV placebo-controlled, parallel group, comparative studies of ipragliflozin in patients with T2DM were pooled. (bvsalud.org)
In randomised, placebo-controlled trials of patients with T2DM, ipragliflozin was well tolerated, with a similar overall incidence of TEAEs to placebo. (bvsalud.org)
For the clinically evaluable patients, the clinical cure rates at the TOC visit were comparable for the MRX-I 800 mg group (96.5 percent) and the linezolid group (95.5 percent). (outbreaknewstoday.com)

Dosing the first patient in our Phase 2 clinical trial evaluating the combination of samuraciclib and elacestrant is an important milestone in our goal of improving outcomes for women fighting metastatic breast cancer," said Tim Pearson, Chief Executive Officer of Carrick Therapeutics. (ntb.no)
Prior to joining Usona, Mr. Barrow served as Chief Operating Officer of Olatec Therapeutics where he oversaw the execution of numerous early- and late-stage clinical trials in the fields of analgesics, rheumatology, immunology and cardiovascular disease. (shroominvestor.com)

The Phase 2 clinical trial is designed to evaluate the company's CXCR4 inhibitor motixafortide in combination with PD-1 inhibitor cemiplimab and standard of care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in first-line pancreatic cancer (PDAC). (kron4.com)
This trial will include 60 healthy individuals, 18 years of age or older, and is designed to specifically evaluate the safety profile and immunogenicity of 2 dose levels of GEO-CM04S1 as a booster shot. (geovax.com)
A third Phase II clinical trial will evaluate UV1 in a new cancer indication combined with indication-specific standard of care cancer therapies different from those to be tested in INITIUM and NIPU. (precisionvaccinations.com)
The trial will initially evaluate the tolerability and pharmacokinetics of the combination then recruit an expansion cohort evaluating the longer-term progression free survival benefits. (ntb.no)
Novavax announced that the first volunteers have been enrolled in the Phase 2 portion of its ongoing clinical trial to evaluate the immunogenicity and safety of NVX-CoV2373, Novavax' COVID-19 vaccine candidate. (expresspharma.in)

Data from preclinical and clinical studies in a variety of solid tumors have shown evidence of tumor kill, minimal local or systemic toxicity, and favorable antitumoral immune effects, which includes published preclinical research of NanoDoce synergy in combination with an immune checkpoint inhibitor. (crititech.com)

InMed Pharmaceuticals is a clinical-stage company developing a pipeline of cannabinoid-based pharmaceutical drug candidates, initially focused on the therapeutic benefits of cannabinol ("CBN"), and is developing IntegraSyn™ to produce pharmaceutical-grade cannabinoids. (biospace.com)
Achillion Pharmaceuticals is currently carrying out phase 2 clinical trials of their drug ACH-0144471, a Factor D inhibitor with the aim of treating C3G. (mpgnddd.org)
OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today publication of results from a randomized Phase 2 trial in the Journal of Clinical Oncology. (higcapital.com)
These clinical data demonstrate that MRX-I has the potential to be a safe and effective antibiotic for a broad range of infections, including those that are multidrug-resistant," said Dr. Zhengyu Yuan, president and CEO of MicuRx Pharmaceuticals, lnc. (outbreaknewstoday.com)

Fig. 1: Forest plots of clinical outcomes. (nature.com)
Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. (einpresswire.com)

The clinical trial is designed to enroll 120 subjects from approximately 10 medical centers around the United States. (stemcellsportal.com)

Leveraging its pioneering FasTCAR and TruUCAR technology platforms and SMART CART TM technology module, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal cell quality, high therapy cost and lack of effective CAR-T therapies for solid tumors. (biospace.com)
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for cancers and many of the world's most threatening infectious diseases. (geovax.com)
Prancer RTSM Ⓡ provides the flexibility you need to explore all the possible paths for determining the optimal dose, patient population, and combination therapies within your Phase 2 trials. (4gclinical.com)

The Phase 2 clinical trial expands on the age range of the Phase 1 portion by including older adults 60-84 years of age as approximately 50 per cent of the trial's population. (expresspharma.in)
We expect this Phase 2 portion of the trial to expand on the encouraging Phase 1 safety and immunogenicity data for NVX-CoV2373, and we will now look for robust immune responses in older adults. (expresspharma.in)
Our Phase 3 trial of NanoFlu, which we reported in March of 2020, provided us with a deep understanding of the unique needs of older adults, who are particularly vulnerable to COVID-19. (expresspharma.in)
The clinical trial will assess two dose sizes (5 and 25 µg ), each with 50 µg of Matrix‑M. Although the trial was designed to confirm immunogenicity and safety in adults, secondary objectives include preliminary evaluation of efficacy. (expresspharma.in)
For the general population including adults, the jurisdiction level infection-to-case ratio was a median of 2. (cdc.gov)

Patient-related data not included in the paper were generated as part of a clinical trial and may be subject to patient confidentiality as required by the Health Insurance Portability and Accountability Act. (nature.com)
Phase 1 data in healthy volunteers demonstrated INM-755 (cannabinol) cream to be well-tolerated on both normal, intact skin as well as on open wounds and caused no delay in wound healing. (biospace.com)
The FDA has agreed with Cellceutix's plan to initiate such a trial, and based upon the data from the Phase 1 trial, that the administration of Kevetrin doses at three times per week would be acceptable. (einpresswire.com)
Beyond the promising results of the individual trials, combining data across these six trials into a larger analysis gives us even greater confidence that the treatment effects will apply to other people with PTSD," said Alli Feduccia, Ph.D., Clinical Data Scientist for MAPS Public Benefit Corporation. (maps.org)
Interim Phase 1 clinical data from subcutaneous SGI-110 was previously reported at the American Association for Cancer Research (AACR) 2012 Annual Meeting in Chicago, IL. (technologynetworks.com)
These data provide the foundation and rationale for the upcoming SYNERGY Phase 3 trial evaluating custirsen in approximately 800 men with metastatic CRPC. (higcapital.com)
We know that the world is closely watching all of these trials, and we anticipate interim data from this trial in the fourth quarter of this year," said Gregory M Glenn, President, Research and Development at Novavax. (expresspharma.in)
Based on the initial safety and efficacy results, First Wave BioPharma plans to pursue an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to review the data and discuss the parameters for a registrational Phase 3 clinical trial that would satisfy the requirements for a Biologics License Application (BLA). (microcaps.com)
Preliminary data from the Phase 2 SPAN clinical trial indicate our enhanced microgranule delivery formulation of adrulipase was safe and well tolerated," said James Sapirstein, President and CEO of First Wave BioPharma. (microcaps.com)
The objective of this pooled analysis was to characterise the safety profile of ipragliflozin based on safety data from published randomised controlled trials. (bvsalud.org)
of these, 359 met initial inclusion criteria of including human data from clinical trials published after 2000. (cdc.gov)
The majority of those were excluded as describing different live attenuated dengue vaccines or not including primary trial data. (cdc.gov)
The full data set for MRX-I will inform the design of our planned Phase 3 clinical trials. (outbreaknewstoday.com)
Data from two Phase 1 studies in China and Australia have confirmed that MRX-I was safe and well tolerated in healthy volunteers at all dose regimens, including 28-day repeated dosing regimen alongside Zyvox ® as comparator, with no evidence of myelosuppression that is typical for this class. (outbreaknewstoday.com)
There are some interesting data that came out of the ASPREE trial not too long ago. (medscape.com)
In 2011, 22 drugs that had been approved by the FDA, and 87 Phase I and Phase II clinical trials were listed in the U.S. National Institutes of Health (NIH) data base, www.clinicaltrials.gov . (cdc.gov)
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. (who.int)

Vaccines and curative drug trials are ongoing, as well as missions carried out by preparedness support teams in high-risk countries. (who.int)
In December 2020, less than a year after the SARS-CoV-2 virus was identified, two COVID-19 vaccines manufactured by Pfizer-BioNTech and Moderna were approved for use in the United States under an Emergency Use Authorization by the U.S. Food and Drug Administration (FDA). (cdc.gov)
First proposed in 1989, mRNA vaccines have been studied for years, with several ongoing clinical trials using mRNA vaccines for cancer and viral diseases, including rabies, influenza, and Zika . (cdc.gov)

This pivotal trial achieved its primary endpoint, demonstrating that a high dose of 40 units of Jeuveau can effectively treat glabellar lines with long-term efficacy lasting up to 26 weeks, or 6 months. (blogchicks.com.au)
In this Phase 2 proof of concept trial, MT-7117 met its primary endpoint and was generally well tolerated with an acceptable safety profile. (porphyriafoundation.org)

If the Phase 3 trials demonstrate significant efficacy and an acceptable safety profile, FDA approval is expected by 2021. (maps.org)
2021 Feb;21(2):181-192. (bvsalud.org)

Subjects with Neurofibromatosis Type 2 (NF2) and progressive vestibular schwannoma (VS) will be treated with crizotinib administered orally. (uclahealth.org)
Up to 32 subjects will be randomized to 750mg 2-HOBA or matching placebo three times a day for 4 weeks. (arthritis.org)

BARDA-supported Zika vaccine candidate enters clinical trial [press release] OASPR, DHHS. (cdc.gov)

VINCOV-19 comprises highly purified F(ab')2 antibody fragments that have a high neutralizing capacity against the SARS-CoV-2 virus. (siasat.com)
In the Phase 1 portion of the Phase 1/2 clinical trial, conducted in Australia, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. (expresspharma.in)

Additional information on the Phase 2 trial can be found by ClinicalTrials.gov Identifier: NCT05109091 . (yahoo.com)

The team led by Dr Krishnan H Harshan at CCMB isolated SARS-CoV-2 in April 2020, which led to this successful collaboration. (siasat.com)
We continue to strategically expand our clinical development program for our proprietary cancer vaccine, not only by testing UV1 in additional cancer indications with critical need, such as head and neck cancer," stated Jens Bjørheim, Chief Medical Officer at Ultimovacs ASA, in a press statement issued on December 22, 2020. (precisionvaccinations.com)

The University of Hyderabad (UoH) and the Centre for Cellular and Molecular Biology (CCMB) in collaboration with VINCOV-19, developed the first antidote against COVID-19 and have successfully completed the Phase 2 clinical trials across multiple centres in India. (siasat.com)
This unique initiative will extend the reach of our COVID-19 vaccine booster trial by leveraging EmVenio Research's localized clinical trial model. (geovax.com)
As we continue to advance and explore the potential of GEO-CM04S1 as a more robust and durable COVID-19 booster than currently approved vaccine boosters, this collaboration will help reduce the burden of patient recruitment as it brings clinical research to diverse populations directly in their communities," said David Dodd, GeoVax Chairman and CEO. (geovax.com)
GEO-CM04S1 is a synthetic attenuated modified vaccinia Ankara (sMVA) vector vaccine that expresses spike and nucleocapsid antigens of the SARS-CoV-2 (COVID-19) virus. (geovax.com)
Community volunteers have made this type of research successful, and we are excited to partner with GeoVax on this Phase 2 clinical trial to deliver a potential option for COVID prevention designed by local researchers at City of Hope in Duarte, CA. (geovax.com)
A US drug called RSLV-132 is undergoing phase 2 clinical trials for treating long covid and should end this month. (phoenixrising.me)

ATH434 successfully completed Phase 1 studies demonstrating the agent is well tolerated and achieved brain levels comparable to efficacious levels in animal models of MSA. (yahoo.com)
We are thrilled to be participating in the clinical evaluation of IDCT, as we believe it has the potential to reduce inflammation and restore disc height, as demonstrated in preclinical studies. (businessinsider.com)
Pre-clinical and Phase 1 studies have showed the drug has a favorable safety, tolerability, and pharmacokinetic profile, demonstrating promising potency in pre-clinical models of inflammation and fibrosis without causing immunosuppression. (lupusnewstoday.com)
Currently, Sonlicromanol is in phase II clinical trial in the KHENERGYZE, KHENEREXT and KHENERGYC studies as potent candidate in treatment for mitochondrial diseases. (wikipedia.org)
The safety and efficacy of molnupiravir in children and adolescents have not been established in clinical studies. (who.int)
There are several stages that precede the clinical trial phase of nanomedicine research, including the production of the raw nanomaterial s, synthesis of the pharmaceutical in a lab or manufacturing setting, and preclinical drug studies in animals and in vitro. (cdc.gov)

VINCOV-19 showed an excellent safety profile in the trials. (siasat.com)
GC012F is currently being studied in multiple investigator-initiated trials (IIT) evaluating its safety and efficacy in RRMM, newly-diagnosed multiple myeloma, and B-cell non-Hodgkin's lymphoma (B-NHL). (biospace.com)
Sponsored by Columbia University , the single-arm pilot phase of the Phase 2 trial focused on the safety of the drug combination. (kron4.com)
He further emphasized the commitment of both companies to "continuously validate the efficacy and safety of NABOTA through ongoing clinical trials and to increase our market share worldwide. (blogchicks.com.au)
The primary objective of the Phase 2 Clinical Trial is to further build on the safety profile of C16G2 administration in both dental gel and mouth rinse dosages. (perioimplantadvisory.com)
The final analysis included 30 papers that described Dengvaxia ® safety or efficacy results from clinical trials. (cdc.gov)

Since neutralizing antibodies could block the internalization of SARS-CoV-2 to lung cells, it was postulated that their passive administration should render maximal clinical benefits if they are applied at the early stages of the disease. (siasat.com)
This marks the first time cannabinol has advanced to a Phase 2 Clinical trial to be studied as a therapeutic option to treat a disease. (biospace.com)
The start of this Phase 2 clinical trial represents a very important step forward to test the efficacy of INM-755 (cannabinol) cream in treating epidermolysis bullosa, a disease that has very few treatment options," stated Alexandra Mancini, Senior Vice President of Clinical and Regulatory Affairs at InMed. (biospace.com)
Mr. Barrow is an accomplished pharmaceutical executive and clinical pharmacologist with over a decade of experience leading drug development programs in a variety of disease areas. (shroominvestor.com)
Sonlicromanol (KH176) is a clinical-stage oral drug compound developed by Khondrion as a potential treatment for inherited mitochondrial diseases, such as Leigh's Disease, MELAS and LHON. (wikipedia.org)
Clinical disease varies from a mild, undifferentiated febrile illness to severe disease with shock, hemorrhage and/or severe organ impairment such as hepatitis and encephalitis. (cdc.gov)

Ipragliflozin is a selective sodium - glucose cotransporter 2 (SGLT2) inhibitor approved for the treatment of type 2 diabetes mellitus (T2DM). (bvsalud.org)

We believe custirsen has the potential to reduce treatment resistance thereby increasing the efficacy of various therapeutic agents such as docetaxel, and are hopeful this will be confirmed through the Phase 3 development program," said Scott Cormack, president and CEO of OncoGenex. (higcapital.com)

C3 Jian successfully completes Phase 1 clinical trial for dental caries product C16G2 is a synthetic peptide derived from C3 Jian's proprietary, pheromone signaling platform technology referred to as STAMPs (Specifically Targeted Antimicrobial Peptides). (perioimplantadvisory.com)

The FDA provided excellent guidance regarding several aspects of the planned protocol, including the proposed trial endpoints and insights regarding drugs to be used in combination with Kevetrin. (einpresswire.com)
When changes in protocol design arise, there may be unintended impacts on your clinical trial overall. (4gclinical.com)

This clinical trial is the extension of an earlier collaboration with Ultimovacs that introduced me to the therapeutic potential of the UV1 approach," commented Professor Mascha Binder, M.D., Medical Director and Head of the Immunological Tumor Group at University Medicine Halle. (precisionvaccinations.com)
In this new collaboration, Ultimovacs will supply UV1, and a big pharma company will deliver its proprietary cancer treatment to the clinical trial group, which will sponsor the trial. (precisionvaccinations.com)

The Company expects the trial to be completed in late 2014 with top-line results anticipated in the first quarter of 2015. (newswire.ca)
UoH and CCMB alongside VINS Bioproducts Limited, a leading immunological company, based in Hyderabad developed VINCOV-19, now ready for market authorization and for simultaneous Phase 3 clinical trials. (siasat.com)
The initiation of SGI-110's Phase 2 expansion of the clinical trial marks an important milestone for our company as we advance the development of our second-generation hypomethylating agent," said James S.J. Manuso, PhD, chairman & chief executive officer. (technologynetworks.com)
The Company is currently advancing a therapeutic development pipeline with multiple clinical stage programs built around its two proprietary technologies - the biologic adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients, and niclosamide, an oral small molecule with anti-inflammatory properties. (microcaps.com)

The trial will measure total nasal symptom score (TNSS) and other secondary endpoints. (newswire.ca)

At Usona, Mr. Barrow was responsible for launching the Phase 2 clinical program for psilocybin in the treatment of Major Depressive Disorder and for obtaining Breakthrough Therapy Designation for the program at FDA. (shroominvestor.com)

Additional secondary structural and clinical efficacy objectives are based on changes from baseline in the target knee: cartilage thickness and bone area on qMRI, KOA "progressor" rates, Joint Space Width on X-ray, pain VAS, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total and sub scores, Patient Global Assessment VAS and the proportion of Outcome Measures in Rheumatology (OMERACT)-OARSI responders. (bmj.com)
Enrolment in the Phase 2 segment is currently open, and the first patient has been dosed. (technologynetworks.com)

Today, the overall results of six Phase 2 clinical trials of MDMA-assisted psychotherapy for the treatment of posttraumatic stress disorder (PTSD) were published in the peer-reviewed journal Psychopharmacology . (maps.org)
Home Lifestyle News Daewoong Pharmaceutical Announces Successful 'Extra Strength' Results of US Phase 2 Clinical. (blogchicks.com.au)
Sung-Soo Park , Vice President of Daewoong Pharmaceutical, commented "The conclusive results from the high-dose administration in the Phase 2 clinical trials by our partner Evolus are noteworthy. (blogchicks.com.au)
and (2) Clinical trials: The success of Daewoong Pharmaceutical's products depends on the results of clinical trials. (blogchicks.com.au)
The results of early clinical trials may not be indicative of the results of later-stage or larger-scale clinical trials. (blogchicks.com.au)
Dr. Yuan further noted that, "Adding to our body of clinical knowledge, we have completed dosing in a second Phase 2 trial conducted in the United States, and results will be available in the fourth quarter of 2015. (outbreaknewstoday.com)

ROCCELLA is a multinational 52-week, multicentre randomized double-blind placebo-controlled dose-ranging phase 2 trial for the treatment of OA ( NCT03595618 ). (bmj.com)
NVL-655 has been designed with the aim to address challenges that limit clinical use of existing ALK tyrosine kinase inhibitors (TKIs), including treatment emergent resistance mutations, lack of brain penetrance, and off-target CNS adverse events. (wjbf.com)
As you narrow down the treatment that works, you also should build your supply strategy to expand globally in Phase 3. (4gclinical.com)
The survival analysis provides a strong suggestion of clinical benefit with a hazard ratio consistent with a 50% reduction in the rate of death favoring custirsen treatment," said Dr. Kim Chi, Principal Investigator and medical oncologist at BC Cancer Agency. (higcapital.com)
The drug is currently being evaluated in three on-going Phase 2 clinical trials for the treatment of cystic fibrosis, systemic sclerosis, and dermatomyositis. (lupusnewstoday.com)
In addition to Tonmya for PTSD, Tonix is developing TNX-601 (tianeptine oxalate), a clinical candidate at pre-IND (Investigational New Drug) application stage, designed as a daytime treatment for PTSD and TNX-801, a live synthetic version of horsepox virus, at the pre-IND application stage, to be developed as a potential smallpox-preventing vaccine. (tonixpharma.com)

Cellceutix's anti-psoriasis drug Prurisol is in a Phase 2 trial. (einpresswire.com)
This trial is being conducted pursuant to an Investigational New Drug Application (IND) in conformance with U.S. Food & Drug Administration (FDA) regulations. (stemcellsportal.com)
In his most recent position, Mr. Barrow served as Director of Drug Development & Discovery at the Usona Institute, where he oversaw preclinical, clinical and regulatory development efforts for all of Usona's development programs in psychedelics. (shroominvestor.com)
Mr. Barrow previously served as Director of Drug Development & Discovery at Usona Institute, where he oversaw preclinical, clinical and regulatory development efforts for all of Usona's development programs. (shroominvestor.com)

The PIVOT-HD Phase 2 clinical trial is designed in two parts: an initial 12-week placebo-controlled phase focused on PTC518 pharmacology and pharmacodynamic effect, followed by a 9-month placebo-controlled phase focused on PTC518 biomarker effect. (acnr.co.uk)
allowing for randomized, placebo-controlled, double blind phase 1 clinical trials, performed in healthy male volunteers. (wikipedia.org)

The Phase 2 clinical trial will assess the efficacy of Resunab, administered orally for 84 days and with a 28-day follow-up, at 5 mg, 20 mg, and 20 mg twice daily, at 10 U.S. clinical sites. (lupusnewstoday.com)

and VINS Bioproducts Limited which managed the equine immunization and clinical development in their state-of-art manufacturing plant in Telangana. (siasat.com)
We have been pleased with MacroGenics' conduct of the PROTEGE trial, and we are enthusiastic about the teplizumab clinical development program and expanding our efforts in the area of type 1 diabetes. (science20.com)
C3 Jian appoints Bastiani to Board of Directors 'The advancement of the Phase 2 clinical program for C16G2 is a testament to our development team's talent and the potential of the STAMP technology platform,' said Todd R. Patrick, C3 Jian's President and CEO. (perioimplantadvisory.com)
In joining MindMed, I look forward to delivering on this potential and working to further build and progress MindMed's pipeline of clinical development programs, offering hope to millions of people suffering from addiction and mental health disorders. (shroominvestor.com)
Tonmya is a patented sublingual transmucosal formulation of cyclobenzaprine that is in Phase 3 development. (tonixpharma.com)
In 2006, more than 130 nanotech nologybased drugs and delivery systems had entered preclinical, clinical, or commercial development. (cdc.gov)

The trial is fully enrolled at 15 sites in Germany. (newswire.ca)

Detailed information about the trial, subject eligibility and participating centers can be found by visiting www.clinicaltrials.gov and entering trial ID: NCT03169231. (stemcellsportal.com)

Vice-Chancellor, UoH, Prof. B J Rao, also congratulated the team members for their efforts in successfully completing Phase 2 trials for VINCOV-19. (siasat.com)

Anatomy1

Diseases30

Chemicals and Drugs42

Analytical, Diagnostic and Therapeutic Techniques and Equipment106

Psychiatry and Psychology11

Phenomena and Processes16

Disciplines and Occupations14

Anthropology, Education, Sociology and Social Phenomena12

Technology, Industry, Agriculture4

Humanities7

Information Science15

Named Groups4

Health Care94

Geographicals5

Multicenter6

20194

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Biopharmaceutical company7

Enrollment6

20236

Study67

Interventional1

Investigators5

Participants8

Patients39

Therapeutics2

Evaluate5

Preclinical and clinical1

Pharmaceuticals4

Outcomes2

Enroll1

Therapies3

Adults5

Data17

Vaccines3

Primary endpoint2

20212

Subjects2

Vaccine candidate1

Antibody2

ClinicalTrials.gov Identifier1

20202

COVID6

Studies6

Safety6

Disease6

Inhibitor1

Docetaxel1

Completes1

Protocol2

Collaboration2

Company4

Endpoints1

Therapy1

Patient2

Results6

Treatment6

Drug4

Placebo2

Assess1

Development6

Fully enrolled1

Centers1

Successfully1