Immunovaccine Inc. Successfully Formulates Cel-Sci's CEL-2000 Rheumatoid Arthritis Vaccine in DepoVax(TM)
HALIFAX, NOVA SCOTIA -- (MARKET WIRE) -- 11/08/10 -- Immunovaccine Inc. (TSX VENTURE: IMV) today announced positive results of a preclinical study testing the efficacy of combining CEL-2000, CEL-SCI's rheumatoid arthritis (RA) vaccine antigen, and DepoVax, Immunovaccine's vaccine enhancement and delivery platform. The study results showed the "CEL-2000-DepoVax" combination considerably lessened the symptoms and slowed the progression of RA in the animal model with a single dose. The two companies will continue their research efforts to further optimize the CEL-2000-DepoVax vaccine combination for possible testing in future Phase I clinical trials.
According to the National Institutes of Health (NIH), RA is a form of arthritis that causes pain, swelling, stiffness and loss of function in the joints. The disease affects approximately 2.1 million Americans and two to three times more women than men. CEL-2000 has the potential to slow the progression of rheumatoid arthritis. The DepoVax vaccine delivery technology is amenable to manufacturing and scale up in a GMP setting, providing the potential for quicker clinical development.
"We are extremely pleased that CEL-2000, when delivered in our platform, proved efficacious with as little as one dose," said Dr. Marc Mansour, Immunovaccine's Vice President of Research and Development. "These results provide further validation of the broad potential of our DepoVax vaccine delivery technology."
The study demonstrated that the CEL-2000 formulated in DepoVax vaccine effectively slowed the progression of RA and induced a statistically significant reduction in Arthritic Index (AI) score compared to the untreated control group. An RA vaccine that provides broad protection against rheumatoid arthritis is expected to be better received than current therapies that address the symptoms associated with RA.
The results of this research collaboration were presented today at the annual GTCBio conference in Washington, D.C.
About Rheumatoid Arthritis Treatment
Many drugs are used for managing the pain and slowing the progression of rheumatoid arthritis, but none completely cure the disease. In January 2010, Roche's Actemra (tocilizumab) was approved for the treatment of adult patients with moderate-to-severe RA. Other treatments for RA, such as Johnson & Johnson and Merck & Co.'s Remicade (infliximab) and Amgen/Pfizer's Enbrel (etanercept) were among the 10 largest selling drugs in the world in 2008 with combined global sales of US$12 billion, according to data compiled by Bloomberg.
About CEL-2000
CEL-SCI's rheumatoid arthritis vaccine, CEL-2000, was discovered as part of work with the Company's ongoing research and development activities with its patented L.E.A.P.S. (Ligand Epitope Antigen Presentation System) technology. L.E.A.P.S. is a novel T-cell modulation platform technology that enables CEL-SCI to design and synthesize proprietary immunogens.
CEL-2000 is able to block the inflammatory process earlier and in an antigen-specific manner. Studies have shown that CEL-2000 inhibits the tumor necrosis factor alpha (TNF-alpha). The TNF-alpha is an important therapeutic target because it is a pro-inflammatory cytokine or regulatory protein found in abundance in RA tissue. By targeting the TNF-alpha there is a significant reduction in inflammatory activity.
About CEL-SCI Corporation
CEL-SCI Corporation is developing products that empower immune defenses. Its lead product is Multikine. In Phase II clinical trials Multikine was shown to be safe and well tolerated, and to improve the patients' overall survival by 33 percent at a median of three and a half years following surgery.
CEL-SCI is also developing an immunotherapy (LEAPS-H1N1-DC) to treat H1N1 hospitalized patients and a vaccine (CEL-2000) for Rheumatoid Arthritis using its LEAPS technology platform. The LEAPS-H1N1-DC treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu as CEL-SCI scientists are very concerned about the creation of a new more virulent hybrid virus through the combination of H1N1 and Avian Flu, or maybe Spanish Flu. This investigational treatment is being tested in a clinical study at Johns Hopkins University. The Company has operations in Vienna, Virginia, and near Baltimore, Maryland. www.cel-sci.com
About DepoVax
Immunovaccine's DepoVax platform is a lipid depot-based vaccine delivery and enhancement technology. This patented combination is a breakthrough in vaccine development because it raises unusually strong and long-lasting cellular or humoral immune responses that allow a reduction in the number of doses required for efficacy and earlier onset of protection.
About Immunovaccine Inc.
Immunovaccine Inc. (TSX VENTURE: IMV) is a clinical stage vaccine development company focused on the commercialization of its patented DepoVax vaccine delivery technology and product candidates. The company continues to strengthen its vaccine pipeline through licensing and strategic partnerships to develop therapeutic cancer and infectious disease vaccines. www.imvaccine.com
This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. However, they should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this press release due to risks affecting the Company, including access to capital, the successful completion of clinical trials and receipt of all regulatory approvals. Immunovaccine Inc. assumes no responsibility to update forward-looking statements in this press release.
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Contacts: CEL-SCI Corporation Gavin de Windt Investor Relations (703) 506-9460 [email protected] Immunovaccine Inc. Dr. Marc Mansour Vice President R&D (902) 492-1819 [email protected] Immunovaccine Inc. Jennifer Ayotte Communications (902) 492-1819 [email protected] www.imvaccine.com Tiberend Strategic Advisors, Inc. Andrew Mielach (212) 827-0020 [email protected]
Released November 8, 2010