Innovative chemotherapy treatment schedules: First clinical results in prevention of chemoresistance and enhancement of chemosensitivity in cancer patients

Dresden,Germany, Dec. 10 – RESprotect GmbH today announced successful results of a randomized, single-blind, placebo-controlled phase I/II pilot study of RP101 in cancer patients. RP101 is the Company's first small molecule drug candidate given to cancer patients in combination with standard chemotherapy. This innovative treatment schedule turned out to be safe and well tolerated; in addition, certain side effects of chemotherapy were considerably reduced. Treatment of cancer patients with cytostatics in combination with RP101 will considerably extend survival of cancer patients and greatly improve quality of life.

The pilot phase I/II clinical study with 31 patients carrying five different tumor entities provided preliminary data on efficacy. Our data pointed at focussing to patients with metastasized pancreatic carcinoma. Usually, median survival time for metastasized pancreatic cancer is 3 - 6 months. Response to treatment is described to be less than 10%. In the RESprotect study it was found that three of the four patients with metastasized pancreas carcinoma treated with RP101 + cytostatics underwent remission and are still alive over a period of up to 14 months by now. Of the two patients not treated with RP101, one deceased after one month and the other after 9 months. Even though the number of patients allows no statistical analysis as yet, the treatment success is remarkable.

“The study provided first valuable data that support our unrivaled concept that RP101 prevents chemoresistance and enhances chemosensitivity,” stated Prof. Rudolf Fahrig, CEO of RESprotect. “With these promising results we shall initiate a controlled phase II study in 2004 with metastasized pancreas carcinomas. Other tumor entities will follow."

RESprotect is in the position to offer a unique solution for prevention of chemoresistance and enhancement of chemosensitivity. In contrast to the well known efforts to circumvent or decrease existing chemoresistance, this basic approach is unrivaled. Exploratory research, preclinical data and the limited results of the pilot phase I/II study point at new approaches in treatment of cancer. The development of follow-up compounds with superior characteristics offer additional applications in more indications.

Marketing of patented combination products as well as proprietary follow-up compounds with superior characteristics is planned in cooperation with well positioned multinational partners through cooperation and licensing agreements.