Titan Pharmaceuticals Announces Initiation of Phase II Clinical Study With CeaVac and TriAb for the Treatment of Colorectal Cancer.

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SOUTH SAN FRANCISCO--(BW HealthWire)--Feb. 7, 2002

Study Supported by the National Cancer Institute

Titan Pharmaceuticals Inc. (ASE: TTP) today announced initiation of a Phase II clinical study that will evaluate combination therapy with two of its novel monoclonal antibodies, CeaVac(R) and TriAb(R), for the treatment of Dukes' D colorectal cancer in patients with resected liver metastases.

The Cancer and Leukemia Group B (CALGB), a national clinical research group, is conducting the trial with funding provided by the National Cancer Institute (NCI). The CALGB includes a network of 29 university medical centers, over 185 community hospitals and approximately 3,000 physicians.

The study will assess the safety and preliminary efficacy of CeaVac and TriAb in patients with Dukes' D colorectal cancer that has spread to the liver. Approximately 60 percent of patients with Dukes' D colorectal cancer develop hepatic metastases, or liver tumors. Surgery is often conducted to remove these tumors, however, the majority of patients relapse within two years following surgery. At present, no effective therapy exists for this patient group.

Titan Pharmaceuticals has identified and developed the monoclonal antibodies CeaVac and TriAb as potential treatments for several types of cancer because they both trigger the immune system to recognize and attack targeted cancer cells. CeaVac mimics the carcinoembryonic antigen (CEA), and TriAb mimics the human milk fat globule (HMFG) antigen, both of which are found in high concentrations in colorectal cancer cells, as well as other tumor types.

"In colorectal cancer, tumor cells express both CEA and HMFG in high density," stated Mitchell Posner, MD, Chief of Surgical Oncology at the University of Chicago Medical Center and lead investigator of the CALGB study. "In separate Phase I and Phase II clinical studies, CeaVac and TriAb have each demonstrated the ability to generate excellent immune responses against CEA and HMFG, and we are hopeful that when administered in combination they may provide an enhanced treatment option by simultaneously inducing immune responses against both of these cancer associated antigens."

"We are very pleased that the CALGB and the NCI have launched this important clinical trial," said Dr. Louis R. Bucalo, Chairman, President and CEO of Titan Pharmaceuticals. "The CALGB study takes advantage of the fact that cancer cells often express more than one tumor associated antigen, thereby presenting multiple targets for the immune system to attack. The difficulty has been in designing a standardized therapy capable of inducing the immune system to mount the attack. In previous clinical studies we have shown that both CeaVac and TriAb have this capability. In addition to CeaVac and TriAb, Titan is also developing a third monoclonal antibody, TriGem(R). With three monoclonal antibodies in development, Titan is well positioned to develop an approach to the treatment of various cancer types utilizing these agents in combination to attack tumor cells that express multiple target antigens."

Additional Ongoing CeaVac and TriAb Clinical Trials

The NCI is also funding a Phase II study of CeaVac and TriAb in patients with non-small cell lung cancer that is being conducted by another government sponsored clinical cooperative group, the Radiation Therapy Oncology Group (RTOG). In addition to the studies funded by the NCI, Titan is also conducting a randomized, double-blind, placebo controlled Phase III study of CeaVac for the treatment of Dukes' D colorectal cancer, with over 620 patients enrolled at over 50 sites in the United States and Europe.

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. Iloperidone, 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 programs in cancer therapy are currently in clinical testing, including studies 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.