SAN DIEGO, June 4 /PRNewswire-FirstCall/ -- Metabasis Therapeutics, Inc. announced today that a poster entitled, "A Phase I/II Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of Intravenous (IV) Infusion of MB07133 in Subjects with Unresectable Hepatocellular Carcinoma (HCC)" was presented today at the 42nd Annual Meeting of the American Society of Clinical Oncology (ASCO). The poster provided data on the safety, tolerability and pharmacokinetics from a dose escalation clinical trial the Company has been conducting in patients with primary liver cancer. In addition, preliminary information related to possible signs of drug activity were provided.
The results of the first dose escalation trial show that MB07133 at doses up to 2400mg/m2/day IV infusion is well tolerated in patients with unresectable HCC and that there were no clinically significant dose-limiting toxicities associated with the therapy. A pharmacokinetic analysis was conducted and the results are consistent with MB07133's expected liver targeting mechanism. Although this study was not designed to demonstrate the efficacy of the candidate, encouraging signs of drug activity were observed, including evidence of tumor shrinkage and disease stabilization. Enrollment of the 2400mg/m2/day cohort is ongoing. Should the 2400mg/m2/day dose be determined to be safe and well tolerated the next and final dose escalation will be to the top dose allowed in the protocol, 3000mg/m2/day.
"MB07133 is a novel drug candidate that uses our HepDirect(R) technology to target production of an activated form of cytarabine to the liver," stated Dr. Mark Erion, executive vice president of research and development and chief scientific officer of Metabasis. "Cytarabine is a well known chemotherapeutic that is not effective against primary liver cancer because the liver fails to convert it to its active form. By directly delivering an activated form of cytarabine to the liver, we hope to overcome this limitation while also improving the safety and tolerance of the drug. We believe that the early observations on safety, tolerability, drug pharmacokinetics and disease stabilization reported, although preliminary, suggest that MB07133 warrants further investigation."
Dr. Paul Laikind, chairman, president and CEO of Metabasis said, "Liver cancer is the fifth most common cancer worldwide and a cancer that lacks an approved drug therapy to effectively treat this deadly disease. Although still early in the development of MB07133, the results we have seen to date coupled with the positive results observed in clinical trials of our other HepDirect based drug, pradefovir, are encouraging."
The theme of this year's meeting, held in Atlanta, Georgia June 2nd - June 6th, was "Advocating Survivorship, Clinical Science & Oncology Quality Care" and included numerous session offerings with 27 tracks of disease-specific or oncology-related subject areas and over 4,000 submitted abstracts. Last year's ASCO meeting attracted more than 29,000 attendees from all over the world.
ASCO is a non-profit organization founded in 1964, with overarching goals of improving cancer care and prevention ensuring that all patients with cancer receive care of the highest quality. More than 23,000 oncology health care practitioners belong to ASCO, representing all oncology disciplines and subspecialties.
About Metabasis (http://www.mbasis.com)/
Metabasis Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of novel drugs to address some of the world's most widespread and costly chronic diseases involving pathways in the liver. The Company has established a pipeline that includes clinical stage and preclinical product candidates targeting major diseases with significant unmet medical needs. Targeted diseases include metabolic diseases such as diabetes, hyperlipidemia and obesity as well as liver diseases such as hepatitis and primary liver cancer. Metabasis has developed several proprietary technologies for use in discovering and optimizing drugs, including the NuMimetic(TM) and HepDirect(R) technologies. Metabasis is continuing to identify and develop new product candidates using its proprietary technologies and expertise.
Forward-Looking Statements:
Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, references to the clinical trial results, potential success and further development of MB07133. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause Metabasis' actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, the progress and timing of clinical trials for Metabasis' product candidates; the fact that positive results from clinical trials does not necessarily mean later clinical trials will succeed; serious adverse side effects of, or serious adverse events related to, Metabasis' product candidates or proprietary technologies; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing Metabasis' product candidates; the potential and progress of preclinical compounds and programs; and other factors discussed in the "Risk Factors" section of Metabasis' Annual Report on Form 10-K for the year ended December 31, 2005. All forward-looking statements are qualified in their entirety by this cautionary statement. Metabasis is providing this information as of this date of this release and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.
