FDA Calendar, Extreme Trade Updates: AZN, MDVN, Cardiogenesis Print E-mail
Thursday, 30 July 2009 08:32

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 288 entries as of 7/30/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.

On 7/30/09, Medivation (NASDAQ:MDVN) and Pfizer (NYSE:PFE) announced the initiation of a Phase 3 trial of the investigational drug dimebon (latrepirdine is the proposed generic name for dimebon) in patients with Huntington disease. The international safety and efficacy trial, known as HORIZON, is designed to evaluate the potential benefits of dimebon on cognition (thinking and memory) in patients with Huntington disease (the FDA has granted Orphan Drug status for this indication).

The double-blind, placebo-controlled Phase 3 trial will enroll approximately 350 patients with Huntington disease at approximately 50 sites in North America, Europe and Australia. Patients will be randomized to receive either dimebon (latrepirdine) 20 mg three times daily or placebo for six months. The primary endpoints of the trial are the Mini Mental State Examination (MMSE), which measures cognition, and the Clinician's Interview-Based Impression of Change, plus caregiver input (CIBIC-plus), which measures global function.

On 7/30/09, AZN announced the company has submitted a New Drug Application (NDA) to the FDA and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for an investigational drug, vandetanib (proposed brand name Zactima) 100 mg for use in combination with chemotherapy for the treatment of advanced non-small cell lung cancer (NSCLC) in patients previously treated with one prior anti-cancer therapy.

The U.S. and European submissions are supported by data from Phase 3 clinical studies evaluating the safety and efficacy of vandetanib 100 mg in combination with chemotherapy. Evaluation of vandetanib is ongoing, as monotherapy or in combination with other anti-cancer therapies in a range of tumour types, including thyroid cancer. Results from the ZEPHYR (300mg monotherapy study in EGFR failures in advanced NSCLC, Phase 3) and ZETA (300 mg monotherapy in advanced medullary thyroid cancer, Phase 3) studies will be presented during 1H10.

On 7/30/09, Cardiogenesis (CGCP.PK) announced that it has submitted a pre-IDE (Investigational Device Exemption) to the FDA to initiate a feasibility trial for its PHOENIX System in patients with refractory angina. The PHOENIX Combination Delivery System combines intramyocardial laser channeling with the delivery of a biologic substance. The PHOENIX received a CE MARK in 2006 and there have been over 50 clinical cases completed to date outside of the U.S.

The Company plans to evaluate the therapeutic effect of delivering Platelet Rich Plasma (PRP) in combination with TMR. PRP is derived from the patient's own circulating blood and is well documented in clinical applications for its angiogenic (stimulation of blood vessels) effect and accelerated wound healing response. Center for Biologics Evaluation and Research (CBER) is the lead reviewing center for the PHOENIX application. The company expects to meet with CBER during the next 60 days (by 9/30/09) to identify any additional information required to begin the feasibility trial.

Disclosure: No positions




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