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Clinical Trial News

This section provides information about recently completed clinical trials. If you cannot find information about a particular clinical trial, you should note that results may not be available even after the trial ends. Some trials end before completion and results are never published.

Pfizer And Lilly Announce Positive Top-Line Results From Phase 3 Trial Of Tanezumab For The Treatment Of Osteoarthritis (OA) Pain

Posted 2 days ago in Clinical Trials

July 18, 2018 - Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced that a 16-week Phase 3 study in patients with osteoarthritis (OA) pain evaluating subcutaneous administration of tanezumab, an investigational humanized monoclonal antibody, met all three co-primary endpoints. The study demonstrated that patients who received two doses of tanezumab separated by eight weeks experienced a... Read more...

Pfizer Initiates Pivotal Phase 3 Program for Investigational Hemophilia B Gene Therapy Fidanacogene Elaparvovec

Posted 4 days ago in Clinical Trials

July 16, 2018 -- Pfizer Inc. (NYSE:PFE) and Spark Therapeutics (NASDAQ:ONCE) announced today that Pfizer initiated a Phase 3 open-label, multi-center, lead-in study (NCT03587116) to evaluate the efficacy and safety of current factor IX prophylaxis replacement therapy in the usual care setting. The factor IX prophylaxis efficacy data obtained in the lead-in study will serve as the within-subject control group for... Read more...

BioSight Launches a Phase 2b Clinical Trial of BST-236 as a First-Line Treatment of Acute Myeloid Leukemia

Posted 10 days ago in Clinical Trials

AIRPORT CITY, Israel, July 11, 2018 /PRNewswire/ -- BioSight Ltd., a pharmaceutical development company focused on the development of targeted oncology drugs, announced today that it has received the FDA and the Israeli Ministry of Health clearance to launch a Phase 2b clinical trial of BST-236 for treatment of Acute Myeloid Leukemia (AML). The trial, which will be launched in the upcoming month, will be... Read more...

Fourth Published Clinical Trial Confirms Long-Term Safety of Niagen Supplementation at High Doses and Shows Potential for Improvement in Liver Health

Posted 10 days ago in Clinical Trials

IRVINE, Calif., July 11, 2018 (GLOBE NEWSWIRE) -- ChromaDex Corp. (NASDAQ:CDXC), an integrated, science-based, nutraceutical company devoted to improving the way people age, announced today that results from a human clinical study of Niagen®, a novel form of vitamin B3, at University of Copenhagen and Aarhus University Hospital, were published yesterday in The American Journal of Clinical Nutrition. The study was ... Read more...

Vidac Pharma Announces Initiation of Phase 2b Clinical Trial of VDA-1102 Ointment in Patients with Actinic Keratosis

Posted 11 days ago in Clinical Trials

Jerusalem, Israel, July 10 2018 – Vidac Pharma, a clinical stage oncology and dermatology focused pharmaceutical company, today announced initiation of a Phase 2b clinical trial of VDA-1102 ointment to treat subjects with actinic keratosis (AK), an early stage of cutaneous squamous cell carcinoma (cSCC), which is a common form of non-melanoma skin cancer. VDA-1102 is a selective allosteric modulator that triggers a... Read more...

miRagen Therapeutics Announces Initiation of Phase 2 Clinical Trial of MRG-201

Posted 11 days ago in Clinical Trials

BOULDER, Colo., July 10, 2018 (GLOBE NEWSWIRE) -- miRagen Therapeutics, Inc. (NASDAQ:MGEN), a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, today announced the initiation of a Phase 2 clinical trial to evaluate MRG-201 in subjects with a predisposition for keloid formation. miRagen is developing MRG-201, a synthetic mimic of microRNA-29 for the potential... Read more...

Cellectar’s CLR 131 Receives FDA Orphan Drug Designation for Treatment of Ewing’s Sarcoma

Posted 12 days ago in Clinical Trials

MADISON, Wis., July 09, 2018 (GLOBE NEWSWIRE) -- Cellectar Biosciences (Nasdaq:CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, announces that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation (ODD) to CLR 131, the company’s lead Phospholipid Drug C... Read more...

KemPharm Announces Top Line Results from KP415.E01 Efficacy and Safety Trial in Children With ADHD

Posted 12 days ago in Clinical Trials

CORALVILLE, Iowa, July 09, 2018 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced top line results from a pivotal efficacy and safety clinical trial of KP415, its investigational attention-deficit/hyperactivity disorder (ADHD) product candidate that contains serdexmethylphenidate (a prodrug of... Read more...

Results of Phase III (PIX306) Trial Evaluating Progression-Free Survival of Pixuvri (pixantrone) Combined with Rituximab in Patients with Aggressive B-cell Non-Hodgkin Lymphoma

Posted 12 days ago in Clinical Trials

SEATTLE, July 9, 2018 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) and Servier today announced that the pivotal Phase III trial (PIX306) evaluating Pixuvri® (pixantrone) combined with rituximab in comparison to gemcitabine combined with rituximab in patients with aggressive B-cell non-Hodgkin lymphoma (NHL) did not meet its primary endpoint of an improvement in progression-free survival (PFS). "We are ... Read more...

Celgene and Acceleron Announce Luspatercept Achieved Primary and All Key Secondary Endpoints in Phase III ‘BELIEVE' Study in Adults with Transfusion-Dependent Beta-Thalassemia

Posted 12 days ago in Clinical Trials

SUMMIT, N.J. & CAMBRIDGE, Mass.--July 9, 2018 (BUSINESS WIRE)-- Celgene Corporation (NASDAQ: CELG) and Acceleron Pharma Inc. (NASDAQ: XLRN) today announced results from a phase III, randomized, double-blind, multi-center clinical study (BELIEVE). Luspatercept achieved a highly statistically significant improvement in the primary endpoint of erythroid response, which was defined as at least a 33 percent reduction... Read more...

Quark Pharmaceuticals, Inc Announces First Patient Dosed in Phase 3 Clinical Trial of QPI-1002 for Prevention of Acute Kidney Injury Following Cardiac Surgery

Posted 12 days ago in Clinical Trials

Fremont, CA – July 9, 2018 – Quark Pharmaceuticals, Inc., a late clinical-stage pharmaceutical company and leader in the discovery and development of novel RNAi-based therapeutics for unmet medical needs, today announced the first patient dosed in the pivotal Phase 3 clinical trial of QPI-1002 a siRNA targeting p53, for the prevention of acute kidney injury (AKI) and its consequences following cardiac surgery (CS) (... Read more...

Johnson & Johnson Announces Publication in The Lancet Highlighting Robust Immune Response to Janssen’s Mosaic-based Preventive Vaccine Regimen for HIV

Posted 2 weeks ago in Clinical Trials

NEW BRUNSWICK, N.J., 6 July 2018 –Johnson & Johnson today announced that The Lancet has published key early-stage data regarding an investigational mosaic-based preventive vaccine regimen against HIV-1 infection that is in development at its Janssen Pharmaceutical Companies. In the Phase 1/2a APPROACH study, based on the data generated, the vaccine regimen was safe and well-tolerated and elicited a robust HIV a... Read more...

Kolon TissueGene To Start US Phase III Clinical Trial For Invossa

Posted 2 weeks ago in Clinical Trials

ROCKVILLE, Md., July 6, 2018 /PRNewswire/ -- Kolon TissueGene, Inc. ("the Company"), a leader in advanced cell and gene therapies, announced today that Clinical Hold issued by the FDA has been lifted effective July 5, 2018 and that the Company now has FDA Approval to move forward with its clinical trials involving patients diagnosed with knee osteoarthritis (OA). The pivotal phase III trials for US approval of... Read more...

Eisai and Biogen Announce Positive Topline Results of the Final Analysis for BAN2401 at 18 Months

Posted 2 weeks ago in Clinical Trials

TOKYO and CAMBRIDGE, Mass., July 05, 2018 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (NASDAQ:BIIB) (Headquarters: Cambridge, Massachusetts, United States, CEO: Michel Vounatsos, “Biogen”) announced positive topline results from the Phase II study with BAN2401, an anti-amyloid beta protofibril antibody, in 856 patients with early Alzheimer's disease. The study ... Read more...

CTI BioPharma Announces the Continuation without Modification of PAC203 Phase 2 Study of Pacritinib in Patients with Myelofibrosis Previously Treated with Ruxolitinib

Posted 2 weeks ago in Clinical Trials

SEATTLE, July 2, 2018 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today announced that following a planned interim data review by the Independent Data Monitoring Committee (IDMC) of PAC203, the study will continue without modification and that a second interim review will be conducted in the third quarter of 2018. The IDMC did not identify any drug- or dose-related safety concerns and specifically did not... Read more...

Ocugen Initiates Phase 3 Clinical Trial of OCU300 for the Treatment of Ocular Graft Versus Host Disease

Posted 2 weeks ago in Clinical Trials

MALVERN, PA, July 2, 2018 -- Ocugen, Inc., a rapidly growing ophthalmology company developing a rich clinical pipeline of innovative therapies that address rare and underserved ocular diseases, today announced that it has initiated the first of two pivotal, Phase 3 clinical trials of OCU300 for the treatment of ocular discomfort and ocular redness in patients with ocular graft versus host disease (oGVHD) following... Read more...

Celgene and Acceleron Announce Luspatercept Achieved Primary and Key Secondary Endpoints in Phase III ‘MEDALIST’ Study in Patients with Low-to-Intermediate Risk Myelodysplastic Syndromes

Posted 3 weeks ago in Clinical Trials

SUMMIT, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun. 28, 2018-- Celgene Corporation (NASDAQ: CELG) and Acceleron Pharma Inc. (NASDAQ: XLRN) today announced results from a phase III, randomized, double-blind, multi-center clinical study (MEDALIST). Luspatercept achieved a highly statistically significant improvement in the primary endpoint of red blood cell (RBC) transfusion independence of at least 8 consecutive... Read more...

Aclaris Therapeutics Announces Positive Interim Data from Phase 2 study of ATI-502 (a topical JAK inhibitor) in Patients with Alopecia Areata

Posted 3 weeks ago in Clinical Trials

WAYNE, Pa., June 28, 2018 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company committed to identifying, developing, and commercializing innovative therapies to address significant unmet needs in aesthetic and medical dermatology and immunology, today announced positive interim data from its Phase 2 clinical trial (AA-202 Topical) of ATI-502 for the treatment of... Read more...

AHS 2018: Lilly's Emgality (galcanezumab-gnlm) Significantly Reduced Monthly Migraine Headache Days in Patients with Migraine Who Previously Failed Botox (onabotulinumtoxinA)

Posted 3 weeks ago in Clinical Trials

INDIANAPOLIS, June 27, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today results from a post-hoc analysis which demonstrated efficacy of Emgality™ (galcanezumab-gnlm) in patients with episodic and chronic migraine who had previously failed preventive treatment with Botox®* (onabotulinumtoxinA). Detailed results from a post-hoc analysis of three Phase 3 studies (EVOLVE-1, EVOLVE-2 and REGAIN) wi... Read more...

Enteris BioPharma Announces Positive Results from Expanded Phase 2a Clinical Trial of Ovarest (oral leuprolide tablet) for Endometriosis

Posted 3 weeks ago in Clinical Trials

BOONTON, N.J., June 26, 2018 /PRNewswire/ – Enteris BioPharma, Inc., an oral dosage form biotechnology company developing innovative drug products built around its proprietary oral peptide delivery technologies, announced positive results today from the final treatment arm of the Phase 2a clinical trial of Ovarest®, an oral formulation of leuprolide, for the treatment of endometriosis. Ovarest® leverages Enteris’ ... Read more...

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