Raven biotechnologies Initiates Phase 1/2a Trial of RAV12 in Gastrointestinal Cancers
Tuesday January 11, 7:30 am ET
SOUTH SAN FRANCISCO, Jan. 11 /PRNewswire/ -- Raven biotechnologies, inc. announced today it has begun enrollment of a Phase 1/2a trial of RAV12, a therapeutic monoclonal antibody (MAb), in patients with advanced stage colon, stomach and pancreatic cancers at multiple centers in the United States. The Investigational New Drug Application (IND) was activated by the U.S. Food and Drug Administration (FDA) in December 2004.
"The growing population of patients suffering from relapsed gastrointestinal cancers requires innovative treatments with a meaningful impact on the course of the disease," said Dr. Howard Burris principal investigator from the Sarah Cannon Research Institute, Nashville, TN. "We are hopeful that RAV12 will become an option for patients in the treatment of advanced stage adenocarcinoma. We are pleased to be participating in the clinical trial and have dosed the first patients."
The Phase 1/2a, open-label, dose-escalation clinical trial is being conducted at three leading oncology centers in the United States. This trial will include approximately 30 patients with colon, stomach or pancreatic cancer, or other target antigen positive adenocarcinomas, including breast, lung and prostate. The trial is designed to measure the safety and tolerability of RAV12. Raven expects to conclude this trial by the second half of 2005.
"Having initiated this trial of RAV12 brings us one step closer to meeting this serious unmet medical need for patients suffering from GI cancers," said Jennie Mather, Ph.D., President and CEO of Raven. "Meeting this milestone further validates the promise of our discovery platform and demonstrates our ability to bring drug candidates from discovery to the clinic quickly and efficiently."
Dr. Mather will be presenting an overview of the company's progress and strategy as well as outlining the clinical development program with RAV12 at the 23rd Annual JPMorgan Healthcare Conference today January 11 at 1:30 p.m. Pacific Standard Time at the Westin St. Francis Hotel in San Francisco.
About RAV12 - Therapeutic Antibody for Cancer
RAV12 is a high affinity IgG1 chimeric [sorry about that] antibody recognizing a primate restricted N-linked carbohydrate epitope expressed on a number of human carcinomas, especially adenocarcinomas. Preclinical studies have reported that RAV12 is directly cytotoxic against human colon cancer cell lines in vitro. The mechanism of action of RAV12 appears to involve the induction of oncotic cell death, characterized by cell and organelle swelling and loss of membrane integrity. RAV12 is highly efficacious in colon, gastric and pancreatic tumor xenograft models in vivo and has been found to be well tolerated in repeat dose primate toxicology studies.
About GI Cancers
Adenocarcinomas are malignant tumors of the epithelial cells of a gland that typically metastasize by way of the lymphatic system. Greater than 90 percent of colon, stomach, and pancreatic patient tumor samples express the RAV12 carbohydrate epitope, as do a lower percentage of endometrial, ovarian, liver, lung, prostate and breast tumors.
About Raven
Raven biotechnologies, inc. (www.ravenbio.com) is a privately held biotechnology company focused on the simultaneous discovery of novel cell- surface drug targets and the antibody therapeutics to regulate them. Raven's integrated approach is based on proprietary, human tissue-specific progenitor and tumor stem cell lines developed at Raven, plus proprietary methods optimized for producing MAbs targeting cell-surface proteins. This platform rapidly identifies target antigens and therapeutic candidates in their native configuration in the intact cell membrane. The Company has identified candidate therapeutic MAbs for many cancer indications including lung, colon, pancreatic, prostate, breast, brain, and ovarian cancer. |
