Immunovaccine Receives Clearance From FDA to Proceed With Phase 1 Clinical Trial for Its Therapeutic Cancer Vaccine
HALIFAX, NOVA SCOTIA -- (MARKET WIRE) -- 12/09/09 -- Immunovaccine Inc. (TSX VENTURE: IMV) announced today that its Investigational New Drug (IND) application for its therapeutic cancer vaccine, DPX-0907, has been cleared by the U.S. Food and Drug Administration (FDA). DPX-0907 is Immunovaccine's lead therapeutic vaccine candidate. The vaccine uses the DepoVax(TM) platform to deliver tumor specific antigens. DPX-0907 is designed to cause a depot effect that has the potential to stimulate the body's immune system to seek out and destroy cancer cells in patients with breast, ovarian and prostate cancer.
"The successful FDA review of our IND submission confirms our confidence in our regulatory and development strategy," said Dr. Randal Chase, Immunovaccine's president and CEO. "DPX-0907 is an appealing vaccine candidate to advance into human clinical trials because it combines the strength of our DepoVax(TM) platform with cancer signature antigens."
The Phase 1 clinical trial for DPX-0907 will be conducted at five sites in the US and is on track to begin enrolling patients with breast, ovarian, and prostate cancers by the end of Q1 2010. The Phase 1 clinical trial will evaluate the safety and tolerability of Immunovaccine's patented DepoVax(TM) delivery system and seven tumor-associated antigens.
The activity of DPX-0907 has been demonstrated in preclinical models whereby the vaccine produced a specific cellular immune response that was superior to immune responses achieved with other oil depot vaccines. Preclinical research also reveals DPX-0907 does not induce regulatory T-cell immune suppression, therefore enabling a longer lasting anti-tumor immune response. The DepoVax(TM) delivery platform used to formulate DPX-0907 was capable of achieving 100% therapeutic tumor elimination using established preclinical models.
Therapeutic cancer vaccines represent one of the most promising and rapidly advancing frontiers in drug discovery. DepoVax(TM), Immunovaccine's patented vaccine delivery system, has strong preclinical data that has shown it to be a safe and effective way to deliver antigens. The DepoVax(TM) platform is protected by a strong portfolio of issued patents and pending patent applications.
Immunovaccine Inc. (TSX VENTURE: IMV) is focused on the commercialization of its novel vaccine 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: Immunovaccine Inc. Dr. Marc Mansour Vice President R&D (902) 492-1819 [email protected] Immunovaccine Inc. Jennifer Ayotte Director Communications (902) 492-1819 [email protected] www.imvaccine.com
Released December 9, 2009