FDA Calendar Updates: AspenBio, Acrux, Isolagen, Human Genome Sciences

by: Mike Havrilla

Below is a summary of updates to the www..BioMedReports.com database of 242 entries included in the FDA and Clinical Trial Calendars. The two web links below are for the FDA calendar home page and a recent article highlighting 14 extreme trades of companies with market caps below $200M with pending FDA decisions.

The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA deadline dates. The entries are updated on a daily basis as new information becomes available with a total of 103 entries through today. The FDA Calendar includes the following information: company name, ticker, decision date, and description.

The Clinical Trial Calendar includes 139 entries as of today and 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. AspenBio Pharma (APPY): Plans to file a 510(k) with the FDA to seek clearance of the AppyScore ELISA product used in the pivotal trial as soon as the extensive filing application can be completed and reviewed by the Company's regulatory advisors. AspenBio expects that the product indication will be as an, "Aid in the Diagnosis of Appendicitis," to be used in conjunction with other physical and laboratory tests. The clinical trial data analysis supports that the AppyScore analyte MRP8/14, provides valuable clinical information in the diagnosis of patients with lower right quadrant abdominal pain. AspenBio believes that the AppyScore test, upon commercialization,will have a sensitivity and negative predictive value of greater than 90%. -- Data from the pivotal trial also demonstrated that when the AppyScore is interpreted in combination with other commonly used indicators, such as white blood count (WBC), the sensitivity and negative predictive value will be higher.
  2. Acrux [Australia: ACR.AX] (OTCPK:ARUXF): Testosterone MD-Lotion development program achieves key milestone and will be commercialised as AXIRON -Enrollment of 150 men in pivotal Phase 3 open-label trial completed on schedule with trial results expected 3Q09 expected FDA submission during December 2009 - AXIRON targets a global market worth $900 million, growing at 20% per annum.
  3. Isolagen (ILE) submitted a BLA for Isolagen Therapy, which is a novel cell-based therapy for the treatment of wrinkles, with a standard review (10-month) PDUFA decision date of 1/9/10. Isolagen Therapy would represent a new class of treatment in the facial aesthetic market as patients would receive their own cells to repair the skin if the FDA grants approval. Additionally, the company noted that it recently completed a Phase 2/3 trial for the treatment of acne scars with statistically significant efficacy results.
  4. Human Genome Sciences (HGSI): Expected global regulatory filings during Fall of 2009 for Albuferon (albumin-interferon alpha) in treatment of hepatitis C (HCV) types 2 or 3 viral infection - along with Novartis (NYSE:NVS) - announced 3/9/09 met the main goal in a late-stage trial, but failed to show numerically better efficacy compared to standard-of-care, raising questions about the drug's adoption and sending shares crashing to an all-time low below 50 cents, with a rebound to a closing price of 71 cents on Friday.

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