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Executive Summary

MATRIX' "THERAPEUTIC IMPLANTS" IN SITU DRUG DELIVERY SYSTEM is in Phase II for highly resistant anogenital warts known as condylomata acuminata. Privately-held Matrix Pharmaceutical, based in Menlo Park, Calif., projects that Phase III clinicals of its proprietary site-specific Therapeutic Implant drug delivery system in condylomata could begin in early 1991. The company is testing the system to deliver 5-fluorouracil. In addition, the company is in Phase II study of the system in recalcitrant psoriatic plaques and resistant basal cell carcinoma with 5-fluorouracil. A Phase I study of the Therapeutic Implant system in advanced CNS malignancies is underway. Matrix said it is also planning clinical studies for several advanced cancer indications, including head and neck cancer. Therapeutic Implants combine a tissue modifier, frequently epinephrine, with a gel-like matrix -- a patented carrier system generally composed of either collagen or fibrinogen, or a combination -- and the drug to be delivered. The implants, which are bioerodible, are injected serially into the disease site with a syringe. For example, in condylomata, the company is testing a series of four to six injections over an eight-week period. By targeting the drug at a specific, localized site, the impact of the drug should be minimized to surrounding areas, Matrix said. Potentially, the process could overcome the dose-limiting factors of potent drugs such as chemotherapeutic agents and may reduce the potential for drug resistance, the company said. Matrix believes that the Therapeutic Implants delivery system can be used alone or as an adjunct to surgery, radiotherapy or hyperthermia. The implant provides controlled release of the drug while it erodes. The goal is to provide sustained release of a drug in high doses for relatively short periods of time -- a 2,000-fold or more in the amount of drug targeting a disease site through two or three cell cycles, a spokesperson said. In addition to 5-fluorouracil, Matrix is developing Therapeutic Implants incorporating cis-platinum, thiopeta, vinblastine, methotrexate, triamcinolone and genetically engineered cytokines. Additionally, Matrix is looking at the Therapeutic Implants in the form of tissue adhesives to be applied in the tumor bed after a tumor is removed or intraperitoneally in the case of metastasized cancers, such as ovarian cancer, where the cancerous growths are too numerous to eradicate surgically or with conventional therapies. The firm has recently completed an $8 mil. second round of private financing and has raised a total of $13.4 mil. since its incorporation in 1985. The firm was found three years previously. Matrix is now exploring the possibility of R&D partnerships with drug and biotech companies; none have any equity position in the company so far. Matrix co-founders are Edward Luck, who is also chairman, and Dennis Brown, PhD. Luck was a co-founder, VP and director of technical affairs at Collagen from 1974-79. Brown, Matrix' VP-scientific affairs, was assistant professor of radiology at Harvard Medical School's Joint Center for Radiation Therapy and a research associate at Stanford's School of Medicine. Last year, Luck handed the CEO and president duties over to Bert DelVillano, PhD, who joined Matrix after nine years with Centocor, most recently as VP-sales and marketing of Centocor's diagnostics division.

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