Titan Pharmaceuticals Initiates Phase II Clinical Testing of Gallium Maltolate for the Treatment of Prostate Cancer and Multiple Myeloma.

Business Editors

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--April 2, 2001

Titan Pharmaceuticals Inc. (ASE: TTP) announced today that it has initiated randomized, controlled, multi-center Phase II clinical testing of gallium maltolate in patients with metastatic prostate cancer and refractory multiple myeloma.

The Phase II study, which will enroll 58 patients, is designed to assess the safety and preliminary efficacy of gallium maltolate, and is being conducted at several clinical centers in the U.S. Dr. Donald W. Northfelt, M.D., F.A.C.P., Assistant Clinical Professor of Medicine at the University of California, San Diego, and medical oncologist at Eisenhower Medical Center in Rancho Mirage, Calif., is principal investigator of the study.

Gallium maltolate is a novel orally active formulation of gallium, a semi-metallic element that is a potent inhibitor of ribonucleotide reductase, an enzyme that promotes tumor growth. Gallium is also known to concentrate in malignant tumors and sites of infection, and appears to favorably impact calcium deposition, making bones more resistant to degradation caused by cancer metastasis. In 1991, intravenously administered gallium nitrate was approved in the U.S. for the treatment of hypercalcemia of malignancy. In previously published clinical studies, intravenously administered gallium nitrate demonstrated preliminary evidence of anti-tumor activity in several cancer indications, including multiple myeloma, lymphoma and bladder cancer.

Titan's novel product, gallium maltolate, may significantly expand the therapeutic potential of gallium by providing the advantages of enhanced bioavailablity, a potentially improved therapeutic profile and ease of administration. In recent Phase I studies, gallium maltolate demonstrated a very good safety profile, with attainment of targeted serum drug levels, and pharmacokinetics that support twice a day or once a day dosing.

Prostate cancer and multiple myeloma each represent significant therapeutic needs within the cancer arena. Together these cancers affect more than 200,000 new patients in the U.S. each year, and cause more than 40,000 deaths annually.

This clinical study will evaluate three dose levels of gallium maltolate administered in 28-day cycles in an outpatient setting. Study endpoints include safety, and clinical and radiographic evidence of tumor response.

Commenting on the initiation of this study, Dr. Northfelt stated, "There is good previous clinical experience with intravenous gallium nitrate for the treatment of hypercalcemia of malignancy and encouraging data on its activity in several different tumor types. I am optimistic about the potential of gallium maltolate to provide clinical activity as an oral agent. An easily administered, orally bioavailable gallium therapy may offer several potential advantages over the intravenous form and provide an important new approach to the treatment of several types of cancer, particularly those with bone metastasis."

"We are excited to begin this randomized Phase II study of gallium maltolate," stated Dr. Louis R. Bucalo, Chairman, President and CEO of Titan Pharmaceuticals. "This novel product utilizes anti-cancer mechanisms with substantial preliminary evidence of activity in human studies, and may provide an effective, practical and improved therapy for a number of types of cancer."

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 (CNS) disorders, cancer and other serious and life-threatening diseases. Titan has assembled a deep pipeline of products utilizing novel technologies that have the potential to significantly improve the treatment of these diseases. Titan also establishes important partnerships with multinational pharmaceutical companies and government institutions for the development of its products. Zomaril(TM), Titan's novel drug for the treatment of schizophrenia, is being developed through a corporate partnership agreement with Novartis Pharma AG. Titan has also entered into a corporate partnership with Schering AG to develop and commercialize Spheramine(R), a novel treatment for Parkinson's disease. In addition, several clinical programs in cancer therapy are supported by large oncology cooperative groups that are funded by the National Cancer Institute.

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.