NEW YORK, Feb. 14, 2005 (PRIMEZONE) -- Innovate Oncology Inc. (OTCBB:IOVO) today announces that Bioaccelerate Holdings Inc., the company's major and controlling shareholder will assign its rights to develop and commercialize RP101 for Oncology related diseases.
On February 8th, results were announced from an extended Phase I/II clinical study evaluating RP101 in combination with gemcitabine plus cisplatin for the treatment of metastatic pancreatic cancer. RP101 is targeted at preventing cells from developing a resistance to chemotherapy.
In an extended Phase I/II clinical study conducted by ResProtect in Germany, 13 patients with metastasized pancreatic cancer were treated with RP101 and gemcitabine plus cisplatin. Of the patients treated, nine had stage IV disease and four had stage III disease. Per treatment cycle, patients were given 125mg of RP101 four times per day for the first five days of treatment. The treatment was repeated ten days later. The regimen was repeated for up to six treatment cycles (1-6). For the treatment group, the 50% probability of survival was increased to an average of 15 months from an historic average of 7.5 months (p=0.008). The historical control was developed using a separate study of 15 patients with stage IV disease and 7 with stage III treated with gemcitabine and cisplatin (Heinemann et al., ASCO 2003, University Munchen). Ten out of the 13 patients lived or live longer than one year, and six of them are still alive. Additionally, time to tumor progression was increased to 7.5 months versus 4.75 months as seen in the Heinemann control group.
"The results of this study are encouraging and we are excited to be developing this promising drug candidate for the treatment of pancreatic cancer. We believe that RP101 can be useful in expanding the therapeutic window for chemotherapy, possibly extending survival while also improving the quality of life for pancreatic cancer patients," stated Dr. Nigel Rulewski, Senior Vice President of Bioaccelerate Holdings Inc. "Our partnership with AustCancer further confirms our commitment to developing products that address significant, underserved medical needs while simultaneously building value through investment in the early development of exciting technologies."
According to The American Cancer Society, about one out of four patients with cancer of the exocrine pancreas will live at least one year after the cancer is found. In the RP101 study, 10 out of 13 patients lived longer than one year. The group predicts that, in 2005, about 32,180 people in the U.S. will be diagnosed with pancreatic cancer and about 31,800 will die of the disease.
Patients undergoing repeated chemotherapy treatment can build a resistance to the chemotherapy's intended toxic effects and cancer cells continue to grow and spread during treatment. RP101 is intended as a co-treatment with cytostatic drugs to prevent the development of chemotherapy resistance, often noted as a significant challenge for oncologists. In preclinical studies, co- treatment of chemotherapy with RP101 prevented the decrease of apoptotic effects during the course of chemotherapy and reduced non-specific toxicity. In several different in vivo tumor models, the anti-tumor efficacy of chemotherapy was optimized, and toxic side effects were reduced.
In pancreas carcinoma cells, the oncogene STAT3 is over-expressed leading to the suppression of apoptotic (programmed cell death) responses. Additionally, treatment with gemcitabine leads to the over-expression of the DNA-repair gene APEX, commonly implicated in chemoresistance. RP101 has been shown to down-regulate STAT3 and APEX, in different tumor cell lines.
Dr. Nigel Rulewski, Senior Vice President of Bioaccelerate Holdings Inc., and CEO of Innovate Oncology Inc. commented, "It has always been Bioaccelerate's intention to assign the rights to this product to Innovate Oncology. This fits in with Bioaccelerate's model of developing and commercializing products in five therapeutic areas, typically Bioaccelerate will acquire compounds or the rights to develop compounds and then assign them to its portfolio companies to create both value for its portfolio companies and in turn for Bioaccelerate as major shareholder. Innovate Oncology now has a portfolio of ten products in development, 6 in clinical development and 4 in pre clinical development, and we expect these compounds to gain significant value during their development timelines."
About Pancreatic Cancer
The American Cancer Society predicts that, in 2004, about 31,860 people in the U.S. will be diagnosed with pancreatic cancer and about 31,270 will die of the disease. Pancreatic cancer is the fourth leading cause of cancer death in men and women. About 1 out of 4 patients with pancreatic cancer will live at least one year after the cancer is detected, and only about 1 in 25 will survive for five years or more. For metastasized pancreatic cancer, patients are not expected to survive more than two years. Pancreatic carcinoma is inherently resistant to chemotherapeutic regimens, either alone or in combinations. The most active agents have been 5-fluorouracil (5-FU) and the more recently approved gemcitabine. Gemcitabine trials showed a small but statistically significant improvement in overall survival when compared to 5-FU (5.7 vs 4.4 mo). Additionally, gemcitabine improved the quality of life in approximately 25% of patients.
About Innovate Oncology
Innovate Oncology is developing a range of pharmaceuticals that are focused on areas of need within oncology. The global cancer market was valued at $38.5bn in 2003 and is forecast to grow to $53.1bn by 2009. Innovate's lead product in currently in phase II and prevents the development of resistance to commonly used chemotherapeutic agents. In addition another unique molecule has just completed phase I and demonstrated activity in several different tumor types. Phase II studies are due to start shortly. Two of Innovate's other clinical stage projects include improvements of already approved molecule ie paclitaxel and topotecan. Apart from six clinical stage projects, Innovate also has a preclinical project with blockbuster potential. A new method of inhibiting the RAS oncogene has recently been acquired. The RAS oncogene is associated with over 30% of all malignancies and has enormous potential. Other preclinical projects include a monoclonal antibody, a peptide designed to protect the bone marrow from the toxic effect of chemotherapy and a project to find a small molecule activator of a prostate suppressor gene.
About Bioaccelerate Holdings Inc.
Bioaccelerate Holdings Inc. is a pharmaceutical development organization that seeks to acquire, develop and commercialize novel pharmaceutical compounds in an efficient, cost-effective way. Bioaccelerate uses its broad network of academic, industry and capital market relationships to expedite drug development and raise capital to create and fund its subsidiary companies, which are organized by vertical portfolios in five therapeutic areas: oncology, specialty pharmaceuticals, central nervous system disorders (CNS), cardiovascular disease and anti-infectives.
Bioaccelerate conducts its business directly and through its subsidiaries. The company holds majority equity interests in ten biopharmaceutical companies, three of which are public and holds minority interests in four biopharmaceutical companies, two of which are public. The company also holds a minority equity interest in a public nanotechnology company. Bioaccelerate strategy relies on its development network for research, clinical development and project management to guide early-stage compounds from the discovery process through to Phase II/III development where incremental value can be created. Bioaccelerate Holdings is quoted on the Over-The-Counter Bulletin Board under the symbol "BACL.OB". For more information on Bioaccelerate, visit the company's website at http://www.bioaccelerate.com .
Innovate Oncology Safe Harbor Statement
Certain statements contained herein are "forward-looking" statements (as such term is defined in the Private Securities Litigation Reform Act of 1995). Because these statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Specifically, factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to: risks associated with pre-clinical and clinical developments in the biopharmaceutical industry in general and in Innovate Oncology's compounds under development in particular; the potential failure of Innovate Oncology's compounds under development to prove safe and effective for treatment of disease; uncertainties inherent in the early stage of Innovate Oncology's compounds under development; failure to successfully implement or complete clinical trials; failure to receive marketing clearance from regulatory agencies for our compounds under development; acquisitions, divestitures, mergers, licenses or strategic initiatives that change Bioaccelerate's business, structure or projections; the development of competing products; uncertainties related to Innovate Oncology's dependence on third parties and partners. Innovate Oncology disclaims any obligation to update these forward-looking statements.