FOR IMMEDIATE RELEASE

Contact: Clarice Merrill,
Director Finance and Administration
Direct Therapeutics, Inc.
(650) 306-1270, ext. 2

Direct Therapeutics Completes Enrollment of Phase I/II Trial of New Brain Cancer Drug

Treatment Phase Completed and Maximum Tolerated Dose Established for Patients with the Most Common and Deadly Form of Brain Cancer

September 25, 2002 (Redwood City, CA) — Direct Therapeutics, Inc., a privately held drug development company, announced today that it has concluded patient enrollment and treatment for its multi-center Phase I/II study of DTI-015, a new chemotherapeutic drug designed for direct injection to brain tumors. DTI-015 is a unique product that contains the active ingredient carmustine (also known as BCNU) dissolved in an ethanol solvent vehicle.

The Phase I dose-escalation portion of the study was concluded when the company successfully established the Maximum Tolerated Dose for patients with recurrent glioblastoma multiforme (GBM), the most common and deadly form of brain cancer. Treatment for patients in the Phase II portion of the study has also been completed.

"We have met our primary goals of demonstrating the safety of DTI-015 and establishing Maximum Tolerated Dose for patients with this devastating disease " said Edward E. Luck, president and chief executive officer of Direct Therapeutics. "In addition, the Phase II portion of the study is providing important preliminary data about the efficacy of DTI-015 which, when evaluated in conjunction with data from an earlier physician-sponsored study, will give us greater understanding of which patients might benefit most from DTI-015."

Analysis of results from the earlier physician-sponsored Phase I/II study of DTI-015, conducted at the University of Texas M.D. Anderson Cancer Center in Houston, showed a significantly increased median overall survival time of 45 weeks for the recurrent glioblastoma multiforme patients treated at or below Maximum Tolerated Dose. This is nearly twice the 25-week median overall survival time common for patients whose disease has recurred.

Patients in both the Direct Therapeutics and M.D. Anderson studies had recurrent tumors that were deemed inoperable. All had been heavily treated for their disease before entering the study. Many had undergone two or more surgical procedures, all received radiation therapy, and most received intravenous chemotherapy with nitrosoureas, a class of drugs to which cancers often develop resistance.

Carmustine (1-3 bis [2-chloroethyl]-1-nitrosourea), a cytotoxic chemotherapeutic agent from the nitrosoureas family, is commonly used to treat brain tumors by intravenous injection, a method that exposes the whole body to the serious toxicities of the drug. DTI-015, in contrast, is injected directly to brain tumors using standard image-guided stereotactic injection, a minimally invasive surgical procedure similar to that used for obtaining brain tumor biopsies. The ethanol solvent vehicle in DTI-015 transports the carmustine selectively throughout the tumor mass and into both the aqueous and lipid compartments of tumor cells. As a result, DTI-015 rapidly, thoroughly, and selectively saturates tumor tissue with high doses of carmustine not achievable by other means. Direct Therapeutics will complete final analysis of its Phase I/II trial after all clinical data has been gathered. The company is currently preparing the protocol for its Phase III study of DTI-015, and also plans to begin an additional Phase II study of DTI-015 in patients with newly diagnosed glioblastoma multiforme in Europe later this year.

According to the American Cancer Society, there are 36,000 new cases of primary brain cancer diagnosed each year in the United States. Nearly all patients with glioblastoma multiforme, the most common and aggressive form of brain cancer, die from the disease or its complications within two years of first diagnosis.

About Direct Therapeutics

Direct Therapeutics, Inc. is a privately held drug development company using its patented Solvent-Facilitated Perfusion technology to develop drugs for the localized treatment of solid tumor cancers and other diseases. DTI-015, the company’s first product, has received Orphan Drug Designation in both the United States and the European Union. Last year, Direct Therapeutics was awarded a highly competitive Small Business Innovation Research grant by the National Institutes of Health, which the company is using to map the anti-tumor activity of DTI-015 in brain tumors using non-invasive imaging techniques. For more information about Direct Therapeutics, please contact us or visit www.directtherapeutics.com.