RESprotect grants License for RP101 to Kwang Dong PDF Print E-mail

RESprotect grants South Korean License for its anti-cancer drug RP101 to Kwang Dong Pharmaceuticals, Inc.

Dresden, Germany – October 22, 2008 – RESprotect GmbH announced today that it has granted the exclusive rights in South Korea to develop and commercialize RP101, for the treatment of pancreatic cancer in South Korea, to Kwang Dong Pharmaceuticals, Inc., Seoul.

RP101 is targeted at preventing tumor cells from developing resistance to chemotherapy, one of the most challenging areas for oncologists. RP101 is intended as co-treatment with cytotoxic drugs to prevent the development of resistance to chemotherapy.

In the field of cancer therapy, cytotoxic drugs are used to prevent the multiplication of tumor cells by sensitizing tumor cells to apoptosis, a programmed cell death. While repeated chemotherapeutic treatment effectively destroys many malignant cells, such therapy also inadvertently induces chemoresistance among the remaining cancer cells. These cells adapt to the presence of the cytotoxic drugs through alterations in oncogene expression or by induction of genomic instability due to mutation, recombination, and gene amplification events. These changes, in turn, allow the cancer cell to evade chemotherapy-induced apoptosis by over-activating its survival mechanisms. Accordingly, the development of chemosensitizer is needed to diminish the resistance for cytotoxic drugs, but the result is slight in the world.

In a clinical study evaluating pancreatic cancer patients were treated with RP101, and gemcitabine plus cisplatin, results indicated that the probability of survival was increased to an average of 15 months, from a historic average of 7.5 months. Additionally, six and 12-month survival rates for treated patients were 68% and 39%, respectively, compared to historical controls of 47% and 13% for patients treated with gemcitabine alone. In a separate study published in the Journal of Clinical Oncology, patients treated with RP101, gemcitabine and cisplatin had a median survival of 447 days, compared to the historical control of 186 days for patients treated with gemcitabine and cisplatin alone. Median time to progression for the treated patient group was 280 days compared to 104 for the historical control group. In both clinical trials, the most common adverse events were nausea, fatigue, vomiting, neutropenia, anorexia, and fever, toxicities consistent with those expected for gemcitabine alone.

RP101 was also evaluated in preclinical studies for its potential to prevent induction of chemoresistance and enhance chemosensitivity. RP101 has been shown to induce cell death, or apoptosis, and suppresses the expression of genes associated with drug resistance. RP101 has shown biological activity in preclinical and clinical studies for various cancer indications.

RP101 is currently under development by SciClone Pharmaceuticals, Inc. for the treatment of pancreatic cancer in the United States and Canada, and RESprotect has a plan to extend the indication of RP101 such as lung, breast cancer in the near future. Kwang Dong will fund clinical trial costs for Korean regulatory purposes necessary for the successful commercialization of RP101 program. The results of the clinical trials of SciClone and Kwang Dong are freely available to RESprotect.

About RESprotect: RESprotect GmbH is a privately owned Biotech Company located in Dresden, Germany. RESprotect is focusing on unique approaches that inhibit both chemoresistance and the enhancement of chemosensitivity in combination. RESprotect is looking for partners to develop RP101 in Europe, South America and Asia and its follow-on compounds worldwide.