here is some RZYM inf. on angiogenesis. i think there's a more recent release but couldn't find it. opinions welcome.
Ribozyme Pharmaceuticals Submits IND for Anti-Angiogenesis Agent to Treat Cancer
- First Chemically Synthesized Ribozyme Proposed For Clinical Studies -
BOULDER, Colo., Sept. 22 /PRNewswire/ -- Ribozyme Pharmaceuticals, Inc. (RPI) (Nasdaq: RZYM) today announced that it has submitted an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) to begin clinical testing of ANGIOZYME(TM) for the treatment of cancer.
ANGIOZYME(TM) is the first chemically synthesized ribozyme to be studied in human clinical trials. ANGIOZYME(TM) specifically inhibits formation of the VEGF-r (Vascular Endothelial Growth Factor receptor), a key component in the angiogenesis pathway. RPI, as well as other firms, have demonstrated the importance of anti-angiogenesis therapeutics in animal models. If the IND is approved by the FDA, RPI will be the first to enter clinical trials using the mechanism of VEGF-r down-regulation.
Preclinical studies with ANGIOZYME(TM) have illustrated that the compound specifically down-regulates the production of VEGF-R and greatly reduces angiogenesis. In several animal models, the reduction of angiogenesis has resulted in a dramatic reduction of primary tumor growth, metastasis, and tumor neovascularization (the formation of new blood vessels). In addition, ANGIOZYME(TM) has demonstrated an excellent safety profile in pre-clinical toxicology studies in rodents and monkeys. Upon FDA approval of the IND, RPI will initiate Phase I trials in normal human volunteers.
"We are very excited to begin clinical trials in humans to confirm that VEGF is important in human cancers and to demonstrate the safety of ANGIOZYME(TM) in man," said Dr. Thomas Rossing, Vice President of Product Development and RPI. "Since angiogenesis plays an important role in the growth and metastasis of several important human tumors, ANGIOZYME(TM) has the potential to benefit many patients with cancer."
In addition to ANGIOZYME(TM), RPI has several other therapeutic candidates in the pipeline. In collaboration with Chiron, RPI has successfully completed a gene therapy HIV Phase I/IIa trial. RPI also has research programs in cancer and infectious diseases that may produce product candidates.
"This IND represents a very important step in RPI's development of therapeutic ribozyme products," said Ralph E. Christoffersen, CEO and President of RPI. "It is the first example of a chemically synthesized ribozyme that is expected to enter clinical trials, and represents the culmination of several years of research at RPI that has produced serum-stable, highly active ribozymes. We believe that ANGIOZYME(TM) represents the first of a broad new class of therapeutics using chemically synthesized ribozymes, and look forward to developing and commercializing ANGIOZYME(TM) as well as other new ribozyme therapies."
"The potential for ANGIOZYME(TM) in the treatment of cancer patients is vast, since many important metastatic diseases such as renal cell, melanoma, prostate, colorectal, lung and breast cancer require neovascularization for growth and metastasis," said Ernest Borden, MD, Director of the Center for Cancer Drug Development at the Cleveland Clinic, Cleveland, Ohio, and Co-Investigator for the Phase I clinical study. "Given ANGIOZYME(TM)'s novel mechanism of action, I am excited about the possibility of precisely targeting part of the angiogenic processes associated with metastatic diseases."
Ribozymes are naturally occurring enzymes that perform numerous functions, including the cleavage of ribonucleic acid (RNA) molecules. Ribozymes can be designed to recognize, bind, and cleave any mRNA sequence. As human therapeutics, ribozymes can be chemically synthesized or vector-delivered to selectively inhibit disease causing proteins through the specific cleavage of the disease-causing mRNA. Thus, ribozymes are expected to have broad therapeutic applications in numerous clinical settings. At RPI, significant effort has gone into creating a proprietary molecule that is safe, efficacious, and stable in human serum.
RPI has broad intellectual property coverage for its technology and therapeutic candidates. Key ribozyme patents (US Patents No. 5,037,746; 5,093,246; 5,116,742; 5,354,855; and 5,591,610: European Patent No. 0 291 533; Japanese Patent No. 2530906) have issued in each of the major pharmaceutical markets around the world. In addition, RPI has more than 75 issued or allowed patents that cover its technology and applications. |
