FOR IMMEDIATE RELEASE

Contact: Clarice Merrill,

Director Finance and Administration

Direct Therapeutics, Inc.

(650) 306-1270, ext. 2

Direct Therapeutics Announces Orphan Drug Designation For DTI-015, A Novel Brain Tumor Therapy

(Redwood City, CA, August 8, 2000) - Direct Therapeutics Inc., (DTI), a privately-held drug development company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for DTI-015, the company's investigational agent for the treatment of glioblastoma multiforme (GBM), the most common and lethal primary brain cancer.

"The granting of Orphan Drug designation acknowledges that DTI-015 has the potential to provide a significant therapeutic advantage over other approved forms of carmustine, the active drug in DTI-015, for the treatment of GBM," said Edward E. Luck, president and chief executive officer. "The FDA designation complements our strong intellectual property position, which covers our platform solvent facilitated perfusion (SFP) drug delivery technologies and their use in cancer and other conditions." Orphan Drug status provides a seven-year period of post-approval marketing exclusivity for drugs that offer significant therapeutic advantages over approved treatments of conditions that affect 200,000 or fewer patients per year in the U.S.

DTI-015 is a unique product that contains the chemotherapeutic drug carmustine, also known as BCNU, dissolved in absolute ethanol. Solvent facilitated perfusion of BCNU enables the drug to enter both the aqueous and lipid compartments of target tissue, thus achieving rapid drug saturation of the tumor and selective elimination of cancer cells. DTI-015 is administered by image-guided stereotactic injection directly into the tumor, maximizing therapeutic effect while minimizing systemic toxicity and surgical intervention.

DTI-015 has been under evaluation at The University of Texas M.D. Anderson Cancer Center in Houston, Texas in more than 30 patients with inoperable recurrent brain tumors. Preliminary analysis of the results of this phase I dose escalation trial indicates that, though a maximum tolerated dose has not yet been established, a median survival of 45 weeks was observed. This compares with an historical survival rate of 20 to 26 weeks among other brain tumor patients treated at M.D. Anderson. Most of the patients in the historical comparison group had surgical treatment for their disease, while the DTI-015 patients were deemed inoperable.

Each year in the U.S., there are nearly 18,000 new diagnoses and 13,000 deaths due to brain tumors, according to the American Cancer Society. With currently approved therapy, most patients die within one year of first diagnosis or within six months of recurrence.

In addition to the treatment of GBM, DTI-015 is being evaluated in a physician-sponsored clinical trial for the treatment of liver tumors, one of the most common sites of tumor metastases. Other cancers which may be treatable using DTI's technology include melanoma, lung, breast and prostate cancer.

Direct Therapeutics, Inc. is a drug development company using its proprietary solvent facilitated perfusion technology to address the delivery and distribution of drugs for the localized and regional treatment of cancer. Its technology encompasses the development of new products containing anticancer drugs and certain organic solvents that facilitate the penetration of drug throughout tumor tissue and into tumor cells.