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MHRA issues notice of acceptance for BioMarin's GALNS Phase 3 trial in MPS IVA

BioMarin Pharmaceutical Inc. today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK has completed review of the Clinical Trial Application (CTA) and issued a notice of acceptance for the Phase 3 trial of N-acetylgalactosamine 6-sulfatase (GALNS) for the treatment of Mucopolysaccharidosis IVA (MPS IVA). The company expects to initiate the Phase 3 pivotal trial early in the first quarter of 2011.

15 Dec 2010

Positive results from Creabilis CT327 Phase IIa study in atopic dermatitis

Creabilis SA, a clinical stage European biotechnology company addressing unmet medical needs in dermatology, announced positive results in the Phase IIa study of its lead product CT327 in atopic dermatitis.

15 Dec 2010

Ipsen discontinues development of chimeric compound BIM 23A760 for acromegaly

Ipsen announced today that the preliminary data from the ongoing phase IIb study in patients with acromegaly for its chimeric compound BIM 23A760 does not meet the expected inhibition of growth hormone (GH) and IGF-1 levels after repeat dosing. Preliminary phase IIb data showed a strong dopaminergic activity but only weak evidence of somatostatinergic activity.

15 Dec 2010

Myotec, Hybrid merge to form PsiOxus Therapeutics

Myotec Therapeutics, Ltd. and Hybrid BioSystems, Ltd. today announced their merger to form PsiOxus Therapeutics, Ltd. (PsiOxus), a new, development stage biotechnology company using non-traditional approaches to novel therapeutics for cancer and wasting diseases. PsiOxus, which will be led by CEO Dr. John Beadle, boasts a combined pipeline of phase I and II clinical stage assets.

15 Dec 2010

NCI initiates crolibulin/cisplatin combination Phase II trial in anaplastic thyroid cancer

EpiCept Corporation today announced that the National Cancer Institute (NCI) has initiated a Phase II trial with crolibulinTM (EPC2407). The trial will assess the drug's efficacy and safety in combination with cisplatin in patients with anaplastic thyroid cancer (ATC). CrolibulinTM is a vascular disruption and apoptosis inducing agent that has demonstrated potent anti-tumor activity in both preclinical and early clinical studies.

15 Dec 2010

Amira's clinical-stage DP2 receptor antagonist program data to be presented at Pacifichem 2010

Amira Pharmaceuticals, Inc. announced today that it will present preclinical and clinical data from its DP2 receptor antagonist program on December 17, 2010, at Pacifichem 2010 in Honolulu, Hawaii. The data from Amira's clinical-stage DP2 program will be delivered by Brian Stearns, Ph.D., in a presentation titled "Discovery and optimization of a novel series of DP2 antagonists with efficacy in mouse models of COPD and asthma."

15 Dec 2010

CGEN-15001 administration shows dramatic therapeutic potential in CIA animal model

Compugen Ltd. announced today that administration of CGEN-15001 in an animal model of rheumatoid arthritis dramatically ameliorates the clinical symptoms of the disease.

15 Dec 2010

Hemispherx granted extension to modify Ampligen NDA for CFS indication

Hemispherx Biopharma, Inc. announced today that the Food and Drug Administration (FDA) granted a 12 month extension for the Company to modify its NDA in response to a Complete Response Letter (CRL) received November 25, 2009 for the CFS indication.

15 Dec 2010

DARA's KRN5500 reduces allodynia in Phase 2a study for neuropathic pain in cancer patients

DARA BioSciences, Inc. announced today additional positive results from its successfully completed KRN5500 Phase 2a Clinical Study for treatment of neuropathic pain in patients with cancer. Statistically significant primary endpoint results were released earlier.

15 Dec 2010

Abbott initiates ABT-806 Phase 1 trial in EGFR expressing tumors

Life Science Pharmaceuticals (LSP) announced today a milestone related to monoclonal-antibody (mAb) 806 licensed to Abbott. A Phase 1 trial with ABT-806, a humanized version of mAb 806 that selectively targets the epidermal growth factor receptor (EGFR), has been initiated by Abbott in the U.S. The trial will assess the safety and pharmacokinetics of ABT-806 in patients with advanced solid tumors likely or known to express EGFR.

15 Dec 2010

ISTA commences bepotastine besilate nasal spray Phase 2 study in seasonal allergic rhinitis

ISTA Pharmaceuticals, Inc., today announced it has initiated a Phase 2 clinical study of bepotastine besilate nasal spray for the treatment of symptoms associated with seasonal allergic rhinitis, the inflammation of the nasal passages caused by allergies. The randomized, placebo-controlled, parallel-group environmental study will evaluate the safety and efficacy of bepotastine besilate, dosed twice daily, in patients presenting with allergic rhinitis caused by one of the most potent seasonal allergy triggers, Mountain Cedar pollen.

14 Dec 2010

Glycotope receives innovation award 2010 for GlycoExpress technology platform

Glycotope GmbH, a leading glycobiology company, has won the innovation award 2010 jointly presented by the German states of Berlin and Brandenburg in recognition of the company's GlycoExpress™ technology platform. GlycoExpress™ combines a very efficient improvement of the activities and side effects of a broad range of protein biopharmaceuticals with the suitability for a much broader patient population and a very high productivity.

14 Dec 2010

Tolerx commences TRX518 Phase 1 trial in malignant melanoma

Tolerx, Inc., a biopharmaceutical company developing novel therapies to treat autoimmune diseases and cancer by modulating T cell activity, today announced that it has initiated a Phase 1 clinical trial to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of TRX518, a monoclonal antibody designed to enhance the immune system by enabling T cells to more effectively attack cancer cells.

14 Dec 2010

Provectus commences PH-10 Phase 2c trial for psoriasis

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, has initiated a Phase 2c clinical trial of PH-10 for psoriasis. This multicenter, randomized controlled Phase 2c study is expected to enroll up to 90 subjects at four different sites, beginning in late December.

14 Dec 2010

VIVUS submits briefing document to FDA in effort to secure regulatory approval for QNEXA

VIVUS, Inc. today announced that the company, as part of its continuing effort to secure regulatory approval for QNEXA® in the U.S., submitted a briefing document to the Food and Drug Administration (FDA) designed to address items in the FDA's Complete Response Letter (CRL), issued on October 28, 2010. The company also announced that the Endocrine and Metabolic Division of the FDA has granted VIVUS a meeting in the second half of January 2011 to discuss the content of the proposed resubmission.

14 Dec 2010

Clinical trial investigates pomalidomide in only U.S. study for multiple myeloma

Multiple myeloma, a type of blood cancer in which malignant plasma cells are overproduced in the bone marrow, has led to an estimated 20,000 new diagnoses and 11,000 deaths in 2010. Patients with the disease, who have already failed previous treatments, may be considered for a currently enrolling Phase II study, examining a unique drug combination.

14 Dec 2010

Lexicon reports top-line results from LX2931 Phase 2a study in rheumatoid arthritis

Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering breakthrough treatments for human disease, announced top-line results from a recently completed Phase 2a study of LX2931 in patients with rheumatoid arthritis (RA). LX2931 is an orally-delivered, small molecule drug candidate that inhibits sphingosine-1-phosphate (S1P) lyase, an enzyme important for modulating the immune system by controlling S1P levels in lymphoid tissues.

14 Dec 2010

Pharmasset initiates dosing in PSI-7977 exploratory study in HCV

Pharmasset, Inc. announced today that dosing has begun in an exploratory study of PSI-7977, a nucleotide analog polymerase inhibitor, for the treatment of chronic hepatitis C (HCV). The trial will evaluate PSI-7977 400mg QD in combination with ribavirin (RBV), with 0, 4, 8, or 12 weeks of pegylated interferon alfa 2a (Peg-IFN) in treatment-naive patients infected with HCV genotype 2 or 3.

14 Dec 2010

Preliminary results from Phase 1b/2a trial of MediciNova's ibudilast in opioid addicts announced

Drug addiction investigators with joint appointments at Columbia University Medical Center and the New York State Psychiatric Institute along with MediciNova Inc, a biopharmaceutical company publicly traded on the Nasdaq Global Market and the Jasdaq Market of the Osaka Securities Exchange, today reported preliminary results of the company's neurological drug candidate, ibudilast (MN-166/AV411), in a Phase 1b/2a trial in opioid addicts. The study was largely funded by the National Institute on Drug Abuse (NIDA) with MediciNova supplementation.

14 Dec 2010

Unigene enters agreement with GSK to advance oral PTH Phase 2 program for osteoporosis

Unigene Laboratories, Inc. today announced that the Company entered into an amended and restated exclusive worldwide license agreement with GlaxoSmithKline (GSK) to develop and commercialize an oral formulation of a recombinantly produced parathyroid hormone (PTH) analog for the treatment of osteoporosis in postmenopausal women and plans to initiate a Phase 2 study in the first quarter of 2011.

14 Dec 2010

Drug Trial News

MHRA issues notice of acceptance for BioMarin's GALNS Phase 3 trial in MPS IVA

Positive results from Creabilis CT327 Phase IIa study in atopic dermatitis

Ipsen discontinues development of chimeric compound BIM 23A760 for acromegaly

Myotec, Hybrid merge to form PsiOxus Therapeutics

NCI initiates crolibulin/cisplatin combination Phase II trial in anaplastic thyroid cancer

Amira's clinical-stage DP2 receptor antagonist program data to be presented at Pacifichem 2010

CGEN-15001 administration shows dramatic therapeutic potential in CIA animal model

Hemispherx granted extension to modify Ampligen NDA for CFS indication

DARA's KRN5500 reduces allodynia in Phase 2a study for neuropathic pain in cancer patients

Abbott initiates ABT-806 Phase 1 trial in EGFR expressing tumors

ISTA commences bepotastine besilate nasal spray Phase 2 study in seasonal allergic rhinitis

Glycotope receives innovation award 2010 for GlycoExpress technology platform

Tolerx commences TRX518 Phase 1 trial in malignant melanoma

Provectus commences PH-10 Phase 2c trial for psoriasis

VIVUS submits briefing document to FDA in effort to secure regulatory approval for QNEXA

Clinical trial investigates pomalidomide in only U.S. study for multiple myeloma

Lexicon reports top-line results from LX2931 Phase 2a study in rheumatoid arthritis

Pharmasset initiates dosing in PSI-7977 exploratory study in HCV

Preliminary results from Phase 1b/2a trial of MediciNova's ibudilast in opioid addicts announced

Unigene enters agreement with GSK to advance oral PTH Phase 2 program for osteoporosis

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