Drug Trial News

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Esperance Pharmaceuticals begins human clinical trials of its EP-100 cancer therapeutic candidate

Drug discovery and development company Esperance Pharmaceuticals today announced that it has begun enrollment and dosing of patients in a Phase 1 study of EP-100 in patients with advanced solid tumors. EP-100, the lead candidate from Esperance's Cationic Lytic Peptide (CLYP(TM)) platform technology, is a targeted membrane-disrupting peptide (tMDP) designed to seek and destroy cancer cells that over-express luteinizing hormone releasing hormone (LHRH) receptors on their surfaces.

10 Sep 2009

Teva's COPAXONE holds promise for relapsing remitting multiple sclerosis

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today presented data that demonstrated patients treated for 10 and 15 years with COPAXONE® (glatiramer acetate injection) had significant reduction in disease severity. These data, generated from the longest continuous prospective study of any disease modifying therapy in relapsing remitting multiple sclerosis (RRMS), were presented today at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Düsseldorf, Germany.

10 Sep 2009

NIH provides Inviragen second major grant to develop a dengue vaccine

Inviragen has received a $600,000 grant from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, to partially support its continued efforts to develop a safe and effective dengue vaccine. The two-year grant will fund a collaborative effort led by Inviragen and involving scientists at the University of Wisconsin and Division of Vector-Borne Infectious Diseases at the Centers for Disease Control and Prevention (CDC). The supported work will include additional optimization of Inviragen’s vaccine to generate more potent immune responses.

10 Sep 2009

Acceleron's Phase 1 trial of ACE-031 reveals its potential in treating neuromuscular diseases

Acceleron Pharma, Inc., a biopharmaceutical company developing novel therapeutics that modulate the growth of cells and tissues including red blood cells, bone, and muscle, today announced preliminary results from the ACE-031 Phase 1 single dose clinical trial demonstrating that ACE-031 increased lean body mass and muscle volume. The results from this randomized, placebo-controlled study were presented at the 14th International Congress of the World Muscle Society in Geneva, Switzerland.

10 Sep 2009

Human neural stem cells to treat Pelizaeus-Merzbacher Disease

StemCells, Inc. (NASDAQ:STEM) announced today that it will soon initiate with the University of California, San Francisco (UCSF) Children’s Hospital a Phase I clinical trial to evaluate the therapeutic potential of StemCells’ proprietary HuCNS-SC® product candidate (purified human neural stem cells) to treat Pelizaeus-Merzbacher Disease (PMD), a myelination disorder that primarily affects infants and young children.

10 Sep 2009

GI Company's Phase II study demonstrates safety of rhITF oral spray formulation

Published today, as an original investigation, in the peer-reviewed Journal of Clinical Oncology, are statistically significant Phase II clinical results of The GI Company's lead clinical compound, rhITF (recombinant human Intestinal Trefoil Factor) oral spray. The article is titled, "A Phase II, Randomized, Double-blind, Placebo-Controlled Study of rhITF Oral Spray for Prevention of Oral Mucositis in Colorectal Cancer Patients Receiving 5-Fluorouracil-based Chemotherapy."

10 Sep 2009

FDA approves Ascenta's IND for AT-406 multi-IAP antagonist

Ascenta Therapeutics announced today that following the approval by the U.S. Food and Drug Administration (FDA) of its Investigational New Drug (IND) Application for AT-406, an orally-active, small molecule, multi-IAP antagonist, the company will initiate a Phase I clinical trial in patients with advanced cancer during the fourth quarter of 2009.

10 Sep 2009

Phase III trial demonstrates rapid efficacy of Zelrix in treating acute migraine

NuPathe Inc., a specialty pharmaceutical company developing innovative products for the treatment of neurological and psychiatric diseases, today announced data from the pivotal Phase III trial of Zelrix™, a novel transdermal patch in clinical development for the treatment of acute migraine. Zelrix combines NuPathe’s proprietary SmartRelief™ iontophoretic transdermal technology with sumatriptan, the most prescribed treatment for acute migraine in the United States.

10 Sep 2009

Quatrx' second phase 3 study of ospemifene tablets provides positive results

QuatRx Pharmaceuticals Company, a privately-held biopharmaceutical company, today announced positive efficacy results from the second of two patient cohorts in the second pivotal Phase 3 study for Ophena(TM) (ospemifene tablets), the company's investigational compound in development for the treatment of postmenopausal vulvovaginal atrophy (VVA).

10 Sep 2009

Roche conducts third Phase 1 clinical trial utilizing Halozyme’s Enhanze Technology

Halozyme Therapeutics, Inc. (Nasdaq: HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, today announced that the first patient was dosed in a Phase 1 pharmacokinetic clinical trial using Enhanze™ Technology (rHuPH20, recombinant human hyaluronidase) in a subcutaneous formulation of a Roche biologic.

10 Sep 2009

Protox' Phase 2 study of PRX302 for treating BPH provides positive results

Protox Therapeutics Inc. (TSX: PRX), a leader in the development of receptor targeted fusion proteins, today announced positive 12 month data from its open-label Phase 2 study of PRX302 in males with moderate to severe benign prostatic hyperplasia (BPH). The study results indicate that those patients who received an optimal dose of PRX302 continued to demonstrate significant symptomatic relief at 12 months following a single treatment.

10 Sep 2009

Acorda Therapeutics announces Phase 3 Fampridine-SR trial findings

Data from a long-term open-label extension study from the first Phase 3 Fampridine-SR trial, known as MS-F203, showed that 24.9% of extension study participants with multiple sclerosis (MS) met the criteria as Extension Timed Walk Responders (ETWRs) after one year of treatment and demonstrated improved walking speed over a two year period.

10 Sep 2009

Affymax to complete Hematide Phase 3 clinical study by the end of 2009

Affymax, Inc. today announced that it has notified clinical trial sites to complete treatment of patients in the Phase 3 clinical program for the investigational drug, Hematide, by the end of 2009.

10 Sep 2009

Cempra commences Phase 2/3 clinical study of CEM-102 for treating acute bacterial skin structure infections

Cempra Pharmaceuticals today announced that enrollment is underway in an adaptive design Phase 2/3 clinical study with CEM-102 for patients suffering from acute bacterial skin structure infections (ABSSI). CEM-102 is an oral antibiotic with an established record of treating staphylococcal infections outside the United States, including those due to methicillin-resistant Staphylococcus aureus (MRSA).

10 Sep 2009

Galapagos starts new clinical trial for GLPG0259

Galapagos NV (Euronext: GLPG) announced today that it has initiated a second Phase I clinical trial for GLPG0259, a novel candidate drug being developed for rheumatoid arthritis (RA).

10 Sep 2009

Patient enrollment completed in Phase 2b clinical trial for Pyridorin

NephroGenex, Inc., a privately held drug development company focusing on kidney disease, today announced the completion of patient enrollment in its Phase 2b clinical trial (PYR-210) studying the safety and efficacy of its lead drug candidate Pyridorin (pyridoxamine dihydrochloride) in type 2 diabetic patients with overt diabetic nephropathy. Three hundred and seventeen (317) patients have been randomized.

10 Sep 2009

American Medical News examines clinical trials outsourcing

American Medical News examines the ethical considerations of outsourcing pharmaceutical clinical trials to developing countries. The article highlights how it is less expensive for a drug company to conduct a trial in India, where it runs about $2,000 to track a patient through a trial, compared to the cost in the U.S., which is "10 times more."

9 Sep 2009

Phase II trial of ANA598 commenced by Anadys Pharmaceuticals

Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) announced today that dosing has begun in a Phase II trial of ANA598 in patients chronically infected with hepatitis C virus (HCV). The study will evaluate ANA598 over 12 weeks, taken in combination with pegylated interferon-alpha and ribavirin, in treatment naive HCV patients. ANA598 is an investigational, oral, non-nucleoside polymerase inhibitor.

9 Sep 2009

Protox Therapeutics to present TRIUMPH clinical study update

Protox Therapeutics Inc., a leader in the development of receptor targeted fusion proteins, today announced that Dr. Fahar Merchant, President & CEO of Protox Therapeutics, will present at the 11th Annual Rodman & Renshaw Healthcare Conference.

9 Sep 2009

VIVUS' Phase 3 studies find Qnexa effective in tackling obesity

VIVUS, Inc. (Nasdaq: VVUS) today announced positive results from two final, phase 3 pivotal 56-week studies, EQUIP (OB-302) and CONQUER (OB-303), evaluating the safety and efficacy of Qnexa(TM), an investigational drug, in more than 3,750 patients across 93 sites. The EQUIP and CONQUER studies met all primary endpoints by demonstrating statistically significant weight loss with all three doses of Qnexa, as compared to placebo.

9 Sep 2009