ONYX Begins Testing of Adenovirus in Pancreatic Cancer.RICHMOND, Calif.--(BW HealthWire)--March 3, 1997--ONYX Pharmaceuticals Inc. (NASDAQ NASDAQ
in full National Association of Securities Dealers Automated Quotations
U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :ONXX) announced today that it has expanded Phase I human clinical testing of its lead anticancer agent, ONYX-015, to include patients with pancreatic cancer pancreatic cancer
Malignant tumour of the pancreas. Risk factors include smoking, a diet high in fat, exposure to certain industrial products, and diseases such as diabetes and chronic pancreatitis. Pancreatic cancer is more common in men. .
This is the second Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained
phase I that ONYX has initiated with ONYX-015. The first Phase I study, directed at head and neck tumors, began in April 1996.
ONYX-015 is a genetically engineered genetically engineered adjective Recombinant, see there adenovirus adenovirus
Any of a group of spheroidal viruses, made up of DNA wrapped in a protein coat, that cause sore throat and fever in humans, hepatitis in dogs, and several diseases in fowl, mice, cattle, pigs, and monkeys. that efficiently replicates in and kills tumor cells deficient in the p53 tumor suppressor gene tumor suppressor gene
A gene that suppresses cellular proliferation. When inherited in a mutated state, it is associated with the development of various cancers, including most familial cancers. Also called antioncogene. product. Mutations in p53 are the most common type of genetic abnormality in cancer, occurring in more than 50 percent of human cancer cases, including more than 50 percent of pancreatic cancers.
In this new study of ONYX-015, the product is administered either 1) by using computer-assisted tomography to guide the injection directly into the tumor mass; or 2) intra-operatively if, during surgery, it is discovered that a tumor cannot be completely removed. The patient would then receive an immediate intra-tumoral injection of ONYX-015.
The Phase I study is designed to determine safety and maximally tolerated dose, to assess the patient's immune response immune response
An integrated bodily response to an antigen, especially one mediated by lymphocytes and involving recognition of antigens by specific antibodies or previously sensitized lymphocytes. to the injected virus and to investigate any effects of the virus on tumor growth. The principal investigator Noun 1. principal investigator - the scientist in charge of an experiment or research project
scientist - a person with advanced knowledge of one or more sciences for this pancreatic cancer trial is Sean Mulvihill, M.D. of the University of California The University of California has a combined student body of more than 191,000 students, over 1,340,000 living alumni, and a combined systemwide and campus endowment of just over $7.3 billion (8th largest in the United States). San Francisco Medical Center. Alan Venook, M.D. and Robert Warren, M.D. are co-investigators.
When an unmodified adenovirus infects a normal cell, the cell is killed and thousands of virus particles are released to infect neighboring cells. To take control of the cell, the virus must first inactivate in·ac·ti·vate
1. To render nonfunctional.
2. To make quiescent.
in·acti·va p53, which it does by making a protein called E1B 55k. E1B 55k then binds directly to p53 and blocks its function.
The ONYX-015 adenovirus is modified so that it cannot make E1B 55k and, as a result, it does not block the function of p53 in normal cells. Therefore, ONYX-015 cannot replicate efficiently in normal cells and should not destroy them. In the majority of cancer cells, however, the function of p53 is already disarmed through the mutation of the p53 gene or other mechanisms.
When ONYX-015 infects these cells, the virus growth cycle proceeds unchecked, the virus replicates and the cancer cells are killed. New virus particles are produced and neighboring cancer cells are infected and destroyed.
ONYX Pharmaceuticals was founded in 1992 for the purpose of discovering and developing novel therapeutics based upon the genetics of human disease, with an initial emphasis on cancer. The company focuses on defining the function of certain mutated genes which are known to cause cancer, and on developing innovative therapies to reverse the effects of the mutation or to kill the cancer cell.
ONYX pursues a strategy of establishing corporate partnerships that provide complementary skills in drug development, clinical trials, regulatory affairs, marketing and sales.
The statements made in this press release contain certain forward-looking statements that involve a number of risks and uncertainties. Actual events or results may differ from the company's expectations.
In addition to the matters described in this press release, timelines for clinical activity, results of pending or future clinical trials and changes in the status of the company's collaborative relationships, as well as the risk factors listed from time to time in the company's SEC reports, including but not limited to its Registration Statement on Form SB-2, may affect the actual results achieved by the company.
CONTACT: ONYX Pharmaceuticals
Jana R. Cuiper, 510/262-8775