ANGIOZYME Cancer Therapy Demonstrates Dramatic Results in Halting Metastases in Pre-Clinical Studies and Benign Clinical Safety Profile
Business Wire - August 11, 1999 16:15
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BOULDER, Colo.--(BW HealthWire)--Aug. 11, 1999--
Pre-Clinical Efficacy and Clinical Safety Results Reported
Ribozyme Pharmaceuticals Inc. ("RPI")(NASDAQ:RZYM) Wednesday reported data at the International Association for the Study of Lung Cancer meeting in Aspen, Colo. detailing the pre-clinical efficacy and human safety and pharmacokinetics of the new ribozyme cancer drug, ANGIOZYME(TM).
Now, studies at several independent centers have demonstrated significant inhibition of both growth and metastases in pre-clinical models.
Dr. Nassim Usman, vice president of Research at RPI and ANGIOZYME program director, reported that the ribozyme compound completely inhibited metastases in a clinically relevant colorectal cancer model. In addition, ANGIOZYME(TM) was shown to halt tumor growth and metastases in a Lewis Lung murine model.
In addition to pre-clinical studies, results from Phase Ia and Ib trials in normal volunteers and cancer patients were presented. ANGIOZYME was found to be well tolerated with no clinically important side effects with a range of doses up to and including 300 mg/m2. Human serum concentrations following subcutaneous dosing of 100mg/m2 exceeded the level required to achieve efficacy in tumor models for 24 hours.
ANGIOZYME, the first chemically synthesized ribozyme therapeutic to be studied in humans, is designed to cut off the blood supply to tumors preventing growth and metastases. ANGIOZYME inhibits the production of the Vascular Endothelial Growth Factor receptor (VEGF-r), a key molecule in the pathway that triggers angiogenesis, the growth of blood vessels to the tumor.
"ANGIOZYME has now shown efficacy in multiple animal models, has a very benign toxicity profile and has caused no clinically important adverse events in two Phase I clinical trials. Based on these results, we are preparing to enter multi-dose Phase I/II clinical trials in Q4 1999. The combined results of pre-clinical efficacy and very low pre-clinical and clinical toxicity we have obtained to date are very encouraging," said Usman.
Ribozymes are the product of Nobel Prize winning science and are synthetically engineered to act as "molecular scissors" capable of cleaving target RNA in a highly specific manner.
RPI, located in Boulder, is the acknowledged leader in ribozyme therapeutic development. ANGIOZYME is being developed in conjunction with Chiron Corp.
RPI is also partnered with Eli Lilly Corp. for development of HEPTAZYME(TM) for treatment of Hepatitis C virus.
This release may contain forward-looking statements that reflect management's current views of future events and operations. The information is based on management's current expectations but actual results may differ materially due to various factors, including those mentioned in this release, risks and uncertainties, including market conditions, competitive pricing, the successful outcome of clinical trials, the timely receipt of regulatory approvals and those outlined in RPI filings with the SEC. |
