TORONTO, June 27 /PRNewswire-FirstCall/ - A new cancer drug combination that destroys solid tumors by preventing the growth of new blood vessels, which are needed to provide essential nutrients to the growing cancer mass, has had encouraging early results in a Phase I human clinical trial. Significant biological results and one case of complete cancer remission have also been shown under compassionate use conditions.
Microbix Biosystems Inc. and Angiogen LLC, which entered into an agreement to commercialize this proprietary technology, are now actively seeking funding to support further Phase I and II clinical trials.
The solid tumor treatment market in the U.S. is more than $34 billion annually. More than $3.5 billion a year is now spent on colorectal cancer therapy alone, with some $5.4 billion being directed annually into prostate cancer. Over 800,000 new cases of solid tumors are diagnosed annually in the U.S. Over 6 million patients are diagnosed worldwide with solid tumors each year.
Angiogen's broadly patented Angiostatic Cocktail results in the human body itself generating an anti-cancer protein, termed Angiostatin 4.5 (AS4.5). AS4.5 molecules bind receptors that cause endothelial cells to undergo apoptosis (programmed cell death) such that the growth of new blood vessels, that are essential to tumor development, is prevented. The growing tumor is thereby effectively "starved" of the nutrition needed to survive and grow. Microbix manufactures the key component of this new drug therapy, urokinase, at its state-of-the-art facility in Toronto.
A prior clinical study, using low dose Angiostatic Cocktail to treat advanced solid tumor patients, showed encouraging results, including some tumor necrosis and a decline in serum tumor markers. Additionally, in four (of eight) compassionate use cases (50%), cancer patients exhibited positive clinical results, one with complete remission, another with marked reduction in tumor mass, and two others with increased levels of AS4.5 in the bloodstream.
"This patented technology combines two drugs, a protein, urokinase, and a small molecule, both of which are already FDA-approved for other indications. We are hopeful, therefore, that we will be able to move quickly to market," said William J. Gastle, President and CEO of Microbix.
The Angiostatic Cocktail could provide significant advantages in terms of known safety and efficacy when compared with other cancer therapies on the market, or in development. The Angiostatic Cocktail may be effective against a wide variety of cancers because it attacks genetically normal endothelial cells that respond to a tumor's growth factors and which form the tumor's blood supply. It is also possible that it will prevent metastatic spread of solid tumors.
"This therapy shows great promise for treating prostate, colon and other solid human cancers," said Mark Arizmendi, President of Angiogen. "The Angiostatic Cocktail could have use in patients where other treatment regimens, such as hormonal blockade or chemotherapy, may have failed. It may also be used to enhance the efficacy of other therapeutic approaches."
The two companies have entered into a worldwide exclusive agreement whereby Angiogen will receive a royalty from sales of the treatment and Microbix will generate revenue by supplying the urokinase used in the drug cocktail.
Microbix specializes in developing proprietary biological technologies and commercializing them through global partners. In addition to urokinase, the company's major products include a proprietary vaccine technology and a patented animal reproductive technology. The company also manufactures and markets several virology products. Established in 1988, Microbix is headquartered in Toronto.
Angiogen, LLC is a privately-held biopharmaceutical company established in Illinois in 1999 that seeks to commercialize technologies to treat solid vascular tumors. The Angiostatic Cocktail was developed by Dr. Gerald Soff, the Company's founder and Chief Scientific Officer, at Northwestern University.
This press release contains forward-looking statements, which are subject to risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements. The Company's initiatives in all its business areas, including R&D, manufacturing, quality affairs, clinical trials, licensing agreements, patents and intellectual property, financing and regulatory affairs are subject to risks and uncertainties, some of which may be unknown to the Company. Risks and uncertainties include, but are not limited to, the Company's initiatives to secure third party licensing agreements, potential partners' assessment of the patents and intellectual property underlying the Angiostatic Cocktail, funding to undertake clinical trials and efficacy of the Angiostatic Cocktail in those trials, success of the process leading to regulatory approval, the ability of the Company to manufacture urokinase. These forward-looking statements represent the Company's judgment as of the date of this press release. The Company disclaims any intent or obligation to update these forward-looking statements.
Microbix Biosystems Inc.