FDA, Clinical Trial Calendar Updates: THOR, ALTH

The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

1.) Thoratec (THOR): Based on previously reported (December 2008) positive interim Phase 3 clinical trial results for its HeartMate II Pump and discussions with the FDA, THOR announced the filing today of a PMA (Pre-Market Approval) supplement seeking to add the intended use of Destination Therapy for the HeartMate II LVAS (left ventricular assist system).

The HeartMate II is a next generation heart assist device designed to provide long-term cardiac support for patients suffering from advanced stage heart failure. THOR has provided guidance for a possible approval during early 2010, but there are no firm PDUFA decision dates issued by the FDA for the review of medical devices.

The device was approved for Bridge-to-Transplantation in the U.S. under the original PMA in April 2008, and the filing today includes data on a pivotal study cohort of 200 randomized patients, including two-year data on the first 167 patients enrolled. The filing also provides data on adjunctive cohorts totaling an additional 409 patients, including those who had been originally supported by an XVE who then elected to receive a HeartMate II, based on the need for device replacement, and patients enrolled under Continuous Access Protocols (CAPs). THOR plans to file an amendment to the PMA supplement submission with complete two-year data on all 200 randomized patients at the end of June.

In December 2008, Thoratec received approval from the FDA to end randomization in the trial, based on a pre-specified interim analysis of 67 percent of the first 200 patients that showed that patients implanted with the HeartMate II achieved statistically superior outcomes versus those in the control group who were implanted with the HeartMate XVE.

2.) Allos Therapeutics (ALTH): Yesterday, ALTH presented new data at the American Association for Cancer Research Annual Meeting which demonstrated the anti-cancer activity of its investigational drug, pralatrexate, in colon, ovarian, lung, prostate, and head and neck cancer cell lines. The preclinical research further showed that the antiproliferative effects against these cancer lines were achieved at drug concentrations that are attainable in humans. These data were presented today in Denver, CO.

The results were outlined in a poster presentation (Cytotoxicity of Pralatrexate, a Novel Synthetic Antifolate, in Human Cancer Cell Lines, abstract #1686) and highlights anticancer activity for pralatrexate in nine of 15 human cell lines tested. The presentation also demonstrated a rapid anti-cancer effect for the drug (within 24-72 hours) and the identification of a potential enzyme biomarker (folyl-polyglutamate synthetase or FPGS) to predict which patients will benefit from treatment with the drug.

The following is the entry from the BioMedReports.com FDA calendar for ALTH: Filed NDA on 3/25/09 with FDA for pralatrexate in the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (PTCL). ALTH requested priority (six-month) review, 5/25/09 is the date for FDA to accept filing and rule on priority review status. Priority review PDUFA date would be 9/25/09 (versus 1/25/10 for standard, 10-month review). PTCL comprises a biologically diverse group of hematologic malignancies that typically has a worse prognosis than other types of lymphoma and is less responsive to traditional chemotherapy regimens. There are currently no agents approved by the FDA for the treatment of patients with PTCL.

Disclosure: No positions.

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