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.

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LX4211 Achieves Positive Results in Type 1 Diabetes Clinical Trial

Posted 6 days ago in Clinical Trials

The Woodlands, Texas, April 14, 2014 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today positive, top-line results in a Phase 2 clinical trial of LX4211 in type 1 diabetes, which achieved the primary endpoint of reducing mealtime insulin use as well as several secondary endpoints, including improved glycemic control. LX4211 is an oral, first-in-class, dual inhibitor of sodium glucose transporters 1...

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Biogen Idec and Sobi Announce Positive Results from Phase 3 Pediatric Study of Eloctate

Posted 9 days ago in Clinical Trials

CAMBRIDGE, Mass. & STOCKHOLM April 10, 2014 - Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI) today released positive top-line results of the Kids A-LONG Phase 3 clinical study that evaluated the safety and efficacy of ELOCTATE™, an investigational recombinant factor VIII Fc fusion protein product candidate, in children with severe hemophilia A. ELOCTATE was generally...

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Bristol-Myers Squibb Presents Phase III Data Demonstrating Positive Results for Hepatitis C Drugs

Posted 9 days ago in Clinical Trials

PRINCETON, N.J.--(BUSINESS WIRE)--April 10, 2014 -- Bristol-Myers Squibb Company (NYSE:BMY) today announced Phase III results from the global HALLMARK-Dual study investigating the all-oral, interferon- and ribavirin-free regimen of daclatasvir (DCV), a NS5A inhibitor, and asunaprevir (ASV), a NS3 inhibitor, among genotype 1b hepatitis C virus (HCV) infected patients. Results showed that the 24-week regimen achieved...

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Stemline Therapeutics Announces FDA Acceptance of IND for SL-701

Posted 11 days ago in Clinical Trials

New York, April 8, 2014 (GLOBE NEWSWIRE) -- Stemline Therapeutics, Inc. (Nasdaq:STML) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) application for SL-701, which enables the company to advance SL-701 into a Phase 2 trial of adults with glioblastoma multiforme (GBM) in first recurrence. SL-701 is a subcutaneously-administered cancer vaccine...

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Ambit Announces Initiation Of Quizartinib QUANTUM-R Phase 3 Trial

Posted 12 days ago in Clinical Trials

SAN DIEGO, April 8, 2014 /PRNewswire/ -- Ambit Biosciences (Nasdaq: AMBI), a biopharmaceutical company focused on discovery and development of drugs targeting unmet needs in oncology, autoimmune and inflammatory disease, today announced the initiation of the QUANTUM-R Phase 3 clinical trial comparing quizartinib as monotherapy to chemotherapy regimens in relapsed/refractory acute myeloid leukemia (AML) patients with...

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Deciphera Pharmaceuticals Announces Initiation of Phase 1 Cancer Trial for LY3009120 Pan-RAF Inhibitor

Posted 12 days ago in Clinical Trials

Lawrence, KS -- Apr 7, 2014 --Deciphera Pharmaceuticals, a clinical stage biotechnology company focused on improved kinase inhibitor treatments for cancer, today announced the initiation of a Phase 1 clinical trial of its pan-RAF inhibitor LY3009120 (DP-4978), under development in collaboration with Eli Lilly. The Phase 1 trial will evaluate the safety, tolerability and initial efficacy of LY3009120 in cancer...

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Xenetic Biosciences Announces Positive Phase 1 Clinical Data for PulmoXen for Treatment of Cystic Fibrosis

Posted 12 days ago in Clinical Trials

LEXINGTON, Mass., April 7, 2014 (GLOBE NEWSWIRE) -- Xenetic Biosciences, Inc. (OTCBB:XBIO), a biopharmaceutical company focused on developing next-generation biologic drugs and novel oncology therapeutics, today announced the positive results from its Phase I clinical trial of PulmoXenTM for the treatment of cystic fibrosis. The single center, open-label trial was conducted in Russia by Xenetic's partner, OJSC...

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Palbociclib plus Letrozole Significantly Prolonged Progression-Free Survival in Patients with Advanced Breast Cancer

Posted 13 days ago in Clinical Trials

NEW YORK, N.Y., April 6 – Pfizer Inc. today announced detailed results from the PALOMA-1 study, a randomized Phase 2 study of palbociclib (PD-0332991) in combination with letrozole. PALOMA-1 achieved its primary endpoint by significantly prolonging progression-free survival (PFS) compared with letrozole alone in post-menopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2...

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Investigational New Drug Application Cleared by FDA for OMS721 in Thrombotic Microangiopathies

Posted 2 weeks ago in Clinical Trials

SEATTLE, April 3, 2014 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that its Investigational New Drug Application (IND) to evaluate OMS721 for the inhibition of complement‑mediated thrombotic microangiopathies (TMAs) has been cleared by the U.S. Food and Drug Administration (FDA). OMS721 is the company's lead human monoclonal antibody targeting mannan-binding lectin-associated serine...

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Helix BioPharma Corp. Submits L-DOS47 Investigational New Drug Application with U.S. FDA

Posted 2 weeks ago in Clinical Trials

April 3, 2014 -- Helix BioPharma Corp. (TSX, FSE: “HBP”), a biopharmaceutical company developing innovative drug candidates for the prevention and treatment of cancer, today announced the recent submission of an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) for approval to initiate a Phase I clinical trial with L-DOS47. The study is entitled “A Phase I,...

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Cellceutix Reports 20 Percent Enrollment Completed in Phase 2b Trial of Brilacidin as Short-Course Therapy for ABSSSI

Posted 2 weeks ago in Clinical Trials

BEVERLY, MA–(Marketwired – Mar 31, 2014)- Cellceutix Corporation (OTCQB: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, is pleased to provide shareholders an update on the status of the Company’s clinical trial of its novel antibiotic Brilacidin as a treatment for Acute Bacterial Skin and Skin...

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Idera Pharmaceuticals Announces Positive Top-line Data in Phase 2 Trial of IMO-8400

Posted 3 weeks ago in Clinical Trials

CAMBRIDGE, Mass. March 28, 2014 — Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) today announced positive top-line data from its randomized, double-blind, placebo controlled Phase 2 trial of IMO-8400 in 32 patients with moderate-to-severe plaque psoriasis. The primary objective of the trial was to evaluate the safety and tolerability of IMO-8400 over a 12-week treatment period, with a secondary objective to evaluate...

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Insmed Announces Results from Phase 2 Clinical Trial for Treatment Resistant Nontuberculous Mycobacterial Lung Infections

Posted 3 weeks ago in Clinical Trials

MONMOUTH JUNCTION, N.J.--(BUSINESS WIRE)--March 26, 2014 -- Insmed Incorporated (Nasdaq GS:INSM) today reported results from the Company's phase 2 clinical trial of ARIKAYCE, or liposomal amikacin for inhalation, for the treatment of patients with treatment resistant nontuberculous mycobacterial (NTM) lung infections. The randomized, double-blind, placebo-controlled phase 2 clinical trial compared ARIKAYCE (590 mg...

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Galectin Therapeutics to Announce Results From First Cohort of Phase 1 Clinical Trial in Fatty Liver Disease

Posted 3 weeks ago in Clinical Trials

NORCROSS, Ga., March 25, 2014 (GLOBE NEWSWIRE) -- Galectin Therapeutics (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announced that on Monday, March 31, 2014, the Company will report results from the first cohort of its Phase 1 clinical trial examining GR-MD-02 in fatty liver disease (NASH) with advanced fibrosis. The first-in-man study, which...

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Halozyme Announces Positive Results From Phase 1/2 Clinical Trial In Cellulite With HTI-501

Posted 3 weeks ago in Clinical Trials

SAN DIEGO, March 25, 2014 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced top-line data from a proof of concept Phase 1/2 clinical trial evaluating the use of HTI-501 in the treatment of cellulite. The primary endpoint of the clinical trial was met, showing a statistically significant improvement in the appearance of cellulite in the areas of the patients' skin treated with HTI-501 as...

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Kamada Announces Initiation of a Phase 2 U.S. Clinical Trial of Inhaled AAT to Treat Alpha-1 Antitrypsin Deficiency

Posted 3 weeks ago in Clinical Trials

NESS ZIONA, Israel (March 24, 2014) – Kamada Ltd. (Nasdaq and TASE: KMDA), a plasma-derived protein therapeutics company focused on orphan indications, announces the initiation of a new Phase 2 U.S. clinical trial of its proprietary inhaled Alpha-1 Antitrypsin (AAT) therapy for the treatment of Alpha-1 Antitrypsin Deficiency (AATD, or Inherited Emphysema). This trial is a double-blind, placebo-controlled study...

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Provectus Biopharmaceuticals Inc. Submits Application to FDA to Receive Breakthrough Therapy Designation for PV-10 for Treatment of Melanoma

Posted 3 weeks ago in Clinical Trials

KNOXVILLE, Tenn.--(BUSINESS WIRE) March, 24, 2014 --Provectus Biopharmaceuticals, Inc. (OTCQB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, announced today that it has applied to the FDA for Breakthrough Therapy Designation (BTD) for PV-10 for the treatment of melanoma. FDA guidelines state that the Agency will make a decision on the application within 60 days...

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Cellceutix Initiates Clinical Trial of Prurisol as New Treatment for Psoriasis

Posted 3 weeks ago in Clinical Trials

BEVERLY, MA–(Marketwired – Mar 24, 2014)- Cellceutix Corporation (OTCQB: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, is pleased to announce the initiation of the Company’s clinical trial of its oral, small molecule drug candidate Prurisol™ for the treatment of psoriasis. The Prurisol™ tablets...

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CytRx Initiates Pivotal Global Phase 3 Clinical Trial with Aldoxorubicin

Posted 3 weeks ago in Clinical Trials

LOS ANGELES--(BUSINESS WIRE)--Mar. 24, 2014-- CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced it has initiated a pivotal global Phase 3 clinical trial to evaluate the efficacy and safety of aldoxorubicin as a second-line treatment for patients with soft tissue sarcoma (STS) under a Special Protocol Assessment with the FDA. Aldoxorubicin...

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Novartis Reports New Phase III Data Showing Secukinumab (AIN457) Improved Psoriasis

Posted 4 weeks ago in Clinical Trials

EAST HANOVER, N.J., March 22, 2014 /PRNewswire/ -- Novartis today announced results from the Phase III FEATURE and JUNCTURE studies showing secukinumab (AIN457), a selective interleukin-17A (IL-17A) inhibitor, met both co-primary endpoints at Week 12 based on Psoriasis Area and Severity Index (PASI) 75 and Investigator's Global Assessment modified 2011 (IGA mod 2011) 0/1 response rates compared to placebo. Results...

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