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SAN DIEGO, CA - September 23, 2003 -- Metabasis Therapeutics, Inc. (Metabasis) announced today it has begun clinical testing of MB7133, a liver-specific prodrug of the anti-cancer drug cytarabine. MB7133 was developed by Metabasis and is the third Metabasis-discovered product to enter the clinic. The clinical trial is being conducted at two sites, one in the US and one in Hong Kong. The first patient was dosed at the US site and the Hong Kong site is expected to begin enrolling patients in the next dose group. In the current study, MB7133 will be administered by continuous infusion to patients with inoperable primary liver cancer, also known as hepatocellular carcinoma or HCC. Drug safety, tolerability and pharmacokinetics will be monitored. At present, few treatment options are available to patients with HCC and no drugs are approved. MB7133 was developed using Metabasis' proprietary HepDirect™ technology, a prodrug technology that targets production of the biologically active form of the drug specifically to the liver. Liver targeting results in higher active drug concentrations in the liver and minimizes exposure to non-liver tissues. Accordingly, HepDirect prodrugs may improve efficacy, reduce toxicity and thus improve the treatment of liver and liver-related diseases. In the case of MB7133, Metabasis developed a HepDirect prodrug of the anti-cancer drug cytarabine. Cytarabine is used as first line therapy for leukemia but is not effective against liver cancer because unlike leukemic cells, the liver is unable to convert cytarabine to its active form. In contrast, HepDirect prodrugs of cytarabine, such as MB7133, are designed with the goal of bypassing the rate-limiting step in the liver cell and thereby enabling production of high levels of the tumor killing form of the drug. In addition, the liver-specific attribute of the HepDirect technology may help to reduce exposure of tissues outside the liver to the active drug and thereby reduce the potential for side effects. Dr. Paul Laikind, Chairman, President and CEO said, "We are excited about the potential of MB7133 to treat this deadly, poorly treated disease. Primary liver cancer is responsible for as many as a million deaths per year worldwide and it is a growing problem in the United States due to the prevalence of hepatitis B and C. We believe the HepDirect approach overcomes a major drug resistance mechanism that is known to limit cytarabine's ability to treat this disease. With the initiation of these studies we are one step closer to our goal of helping patients with primary liver cancer who currently have little hope." Metabasis Therapeutics, Inc. (www.mbasis.com) is a privately held,
biopharmaceutical company that develops proprietary products principally
for the treatment of liver and liver-related metabolic diseases.
Metabasis has expertise in the fields of nucleoside/nucleotide chemistry
and metabolism, liver biology and liver-specific drug delivery.
Metabasis has discovered and developed a new class of drug candidates
for treating diabetes that act to lower liver glucose production
in diabetic patients. The first drug candidate from this program,
CS-917, is being developed in collaboration with Sankyo Co., Ltd.
and is currently undergoing clinical testing. Metabasis has also
developed its HepDirect technology that allows liver-specific delivery
of new and existing drugs. Two novel drug candidates derived from
the HepDirect technology are in clinical testing: a drug for hepatitis
B called Hepavir B, developed in collaboration with Ribapharm, Inc.,
and a drug for primary liver cancer called MB7133, to which Metabasis
retains exclusive rights.
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