Titan Initiates Phase II Clinical Studies of Pivanex(R) in Leukemia and Melanoma Patient Enrollment in Randomized Phase IIb Study in Lung Cancer Complete SOUTH SAN FRANCISCO, Calif., May 24 /PRNewswire-FirstCall/ -- Titan Pharmaceuticals, Inc. today announced the initiation of two Phase II clinical studies of Pivanex in the treatment of refractory chronic lymphocytic leukemia (CLL) and refractory malignant melanoma. These Phase II studies will assess the preliminary safety and efficacy of Pivanex administered as a single agent in these two disease settings. Titan also announced today that it has completed enrollment in a 225-patient Phase IIb clinical study of Pivanex in combination with docetaxel for second-line treatment of non-small cell lung cancer (NSCLC). This multicenter, randomized, controlled study will evaluate the safety and efficacy of Pivanex plus docetaxel, versus docetaxel alone. The study is being conducted at more than 50 study sites in seven countries, and is expected to be completed by the end of this year. Pivanex is an anti-cancer agent that inhibits histone deacetylases (HDAC), a class of enzymes important for cell growth. Through the process of HDAC inhibition, Pivanex slows tumor growth and causes destruction of cancer cells. In preclinical studies, Pivanex has demonstrated anti-cancer activity against several major human cancers, including NSCLC, CLL and melanoma. Additionally, in preliminary open-label clinical studies, Pivanex has demonstrated activity in the treatment of NSCLC. The encouraging results from these prior laboratory and clinical studies provide the basis for the three ongoing Phase II clinical studies with Pivanex. The open label Phase II study in the treatment of refractory CLL will enroll up to 30 patients, and is being conducted at the Center for Lymphoma and Myeloma at the Weill Medical College of Cornell University. CLL is the most common leukemia in North America, with approximately 10,000 new cases diagnosed in the U.S. each year. "Preclinical data suggest that HDAC inhibition may play an important therapeutic role in the treatment of CLL, and Pivanex represents an important approach based on this novel mechanism of action," said Richard R. Furman, M.D., Assistant Professor of Medicine, Center for Lymphoma and Myeloma at the Weill Medical College of Cornell University, and principal investigator of the CLL Phase II study. The open label Phase II study in the treatment of refractory malignant melanoma will enroll up to 28 patients, and is being conducted at Mt. Sinai Comprehensive Cancer Center in Miami Beach, Florida. Advanced melanoma remains one of the most difficult solid tumors to treat effectively with currently available therapies, and the incidence of melanoma in the United States continues to increase with 54,200 new cases in the U.S. in 2003. "Patients with metastatic melanoma currently have limited treatment options", said Jose Lutzky, M.D., Director, Melanoma Program, Mt. Sinai Comprehensive Cancer Center, and principal investigator of the melanoma Phase II study. "Pivanex has demonstrated both in vivo and in vitro evidence of anti-tumor activity against melanoma, and therefore represents a potential new therapeutic approach to treatment of this disease." About Titan Pharmaceuticals Titan Pharmaceuticals, Inc. (ASE:TTP) is a biopharmaceutical company focused on the development and commercialization of novel treatments for central nervous system disorders, cancer and other serious and life-threatening diseases. Titan's numerous products in development utilize novel technologies that have the potential to significantly improve the treatment of these diseases. Titan also establishes partnerships with multinational pharmaceutical companies and government institutions for the development of its products. The press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to the Company's development program and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of the Company's drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug candidates that could slow or prevent product development or commercialization, the uncertainty of patent protection for the Company's intellectual property or trade secrets and the Company's ability to obtain additional financing if necessary. Such statements are based on management's current expectations, but actual results may differ materially due to various factors, including those risks and uncertainties mentioned or referred to in this press release. DATASOURCE: Titan Pharmaceuticals, Inc. CONTACT: Robert Farrell, Executive Vice President & CFO of Titan Pharmaceuticals, Inc., +1-650-244-4990; or MediaInvestors, Jonathan Fassberg of The Trout Group, +1-212-477-9007, for Titan Pharmaceuticals, Inc.

Copyright