Metabasis Therapeutics (NASDAQ:MBRX) announced after the close today that its MB07133 has been granted orphan medicinal product status for the treatment of hepatocellular carcinoma (primary liver cancer) by the European Commission. This designation would entitle Metabasis with 10 years of marketing exclusivity in the EC if this makes it to approval. MB07133 is a novel HepDirect® prodrug of cytarabine monophosphate (araCMP) designed to produce the oncolytically active form, cytarabine triphosphate (araCTP), in the liver tumor where it acts to inhibit cell proliferation and cause DNA damage resulting in cell death.
Metabasis had only an $87 million market cap at the close of trading and closed at $2.84. Shares are up close to 20% after-hours, and its 52-week trading range is $2.65 to $8.64. As a reminder, this one blew up and imploded back in July into an implosion after the company’s deal with Schering ended after a failed diabetes drug. Will this help it escape being a biotech zombie?
Jon C. Ogg
October 2, 2007
BACKGROUND: Preliminary results from a Phase 1/2 clinical trial forMB07133, which was completed in the second quarter of this year, werepresented at the Annual Meeting of the American Association for CancerResearch (AACR) in April 2007. This first dose escalation trial showedthat MB07133 was well tolerated at doses up to 2400 mg/m2/day whenadministered as a 7 day continuous IV infusion to patients withunresectable HCC. No clinically significant dose-limiting toxicitiesassociated with the therapy and few treatment-related hepatic adverseevents were observed. Additionally, the trial revealed encouragingsigns of drug activity evidenced by intra-hepatic tumor shrinkage andprolonged disease stabilization in some patients. Intra-hepatic tumorreduction was observed in eight patients (29% of those studied), andincreased median overall survival was seen in these patients relativeto the other patients in the study.