PDT Inc. announces promising clinical results.SANTA BARBARA, Calif.--(BUSINESS WIRE)--Dec. 11, 1995--PDT Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :PDTI) Monday announced preliminary Phase I/II clinical results for its first drug, tin ethyl ethyl (ĕth`əl), CH3CH2, organic free radical or alkyl group derived from ethane by removing one hydrogen atom. etiopurpurin (SnET2), for the treatment of certain skin cancers and AIDS-related Kaposi's sarcoma Kaposi's sarcoma (käp`əshē', kəpō`sē), a usually fatal cancer that was considered rare until its appearance in AIDS patients. . At a financial conference Monday in New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of , Gary S. Kledzik, Ph.D., chairman and chief executive officer, stated: ``In the Phase I/II clinical trials, photodynamic therapy photodynamic therapy n. A type of phototherapy in which a nontoxic light-sensitive compound that has been injected into a patient is exposed selectively to light, whereupon it becomes toxic to targeted malignant and other diseased cells. with SnET2 eliminated or reduced a substantial number of tumors and demonstrated an excellent safety profile. ``These preliminary results indicate SnET2 is a promising drug for treating solid tumors, although Phase III studies are needed to provide definitive data. Final preparations are under way with our corporate partner, Pharmacia & Upjohn, for Phase III trials in the U.S. and Europe.'' Photodynamic therapy uses drugs which are activated by light to selectively destroy diseased cells, such as cancer, with minimal effects on normal tissues. The company's first clinical studies with SnET2 involved a combined Phase I/II study for treatment of certain skin cancers, and a second combined study for treatment of AIDS-related Kaposi's sarcoma. These studies assessed the safety of the drug and evaluated the drug and light doses needed to achieve tumor responses. The Phase I/II skin cancer study included basal cell carcinomas (skin cancers caused primarily by sun exposure), basal cell nevus syndrome basal cell nevus syndrome Nevoid basal cell carcinoma syndrome, basal cell carcinoma syndrome, Gorlin-Goltz syndrome A rare AD condition characterized by childhood onset of multiple nevoid basal cell carcinomas accompanied by skin defects, 'pits' in the hands and (a genetic disease which causes multiple, recurrent basal cell carcinomas), and metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. adenocarcinomas (cancers which originate in glands, such as breast cancer, and in this study have metastasized or spread to the skin). This skin-cancer study included a total of 46 patients and 418 tumors. In Phase I, combinations of drug and light doses were investigated. The Phase II portion was conducted at the anticipated optimal drug/light dose. Evaluable tumor responses were as follows: 100 percent of the basal cell carcinomas had complete responses (no visible or palpable evidence of tumor remained). In basal cell nevus syndrome patients, 95 percent of tumors responded. Of the responding tumors, 86 percent were complete responses and 14 percent were partial responses (reduced by 50 percent or more in size). In metastatic adenocarcinoma adenocarcinoma: see neoplasm. patients, 100 percent of tumors responded; 96 percent were complete responses and 4 percent were partial. AIDS-related Kaposi's sarcoma (KS) is a form of skin cancer, usually involving multiple tumors, which often occurs in AIDS cases. This Phase I/II KS study involved an additional 45 patients with a total of 404 tumors. Phase I of this study investigated drug and light combinations. Phase II studies were conducted using the anticipated optimal drug dose and two selected light doses. At the higher light dose, 63 percent of the evaluable tumors responded. 60 percent of the responding tumors were complete responses and 40 percent were partial. The safety of SnET2 was also investigated during these clinical trials. Side effects Side effects Effects of a proposed project on other parts of the firm. were minimal. The most common side effect was mild, transient skin sun sensitivity, which occurred in a small percentage of patients and did not require treatment. No clinically significant abnormal trends were noted in the laboratory parameters. The company emphasized that these data are interim and that final analyses have not been concluded. The primary goal of Phase I/II clinical trials is to assess safety and dosing parameters. Phase III studies are required to determine efficacy. PDT PDT abbr. Pacific Daylight Time PDT Pacific Daylight Time PDT n abbr (US) (= Pacific Daylight Time) → hora de verano del Pacífico PDT , which completed its initial public offering in April 1995, develops pharmaceuticals and devices for photodynamic therapy. Photodynamic therapy is a medical technology that uses light- activated drugs to treat or diagnose diseases in a variety of categories, including cancer, urology urology Medical specialty dealing with the urinary system and male reproductive organs. It traces its origin to medieval lithologists, itinerant healers who specialized in surgical removal of bladder stones. , dermatology, ophthalmology, cardiology and gynecology. PDT's first drug, tin ethyl etiopurpurin (SnET2), was recently licensed by Pharmacia S.p.A., a subsidiary of Pharmacia & Upjohn. CONTACT: PDT Inc., Santa Barbara Laurens Lichty or Jan Wiegand, 805/685-9880 or Paine & Associates Deborah Kazenelson, 818/382-3120 |
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