Immunovaccine Inc. Announces Phase I/II Clinical Plan for DPX-Survivac to Target Ovarian Cancer
HALIFAX, NOVA SCOTIA, Nov 17, 2010 -- Immunovaccine Inc. today announced that it will focus the Phase I/II clinical development plan for DPX-Survivac on ovarian cancer. The development plan was based on positive input from key opinion leaders in cancer immunotherapy. The Company has also successfully manufactured test batches of DPX-Survivac and established the analytical methods to support the release of a future clinical trial batch.
"We look forward to advancing the clinical development of DPX-Survivac as a potential treatment for ovarian cancer," said Dr. Randal Chase, President and CEO of Immunovaccine. "This is a silent disease for which so many women are diagnosed once the cancer is in an advanced stage and treatment options are limited."
About the Development Plan for DPX-Survivac
Initial immunogenicity studies in a mouse model showed that Survivac peptides, formulated in DepoVax(TM), produced more antigen-specific, interferon gamma-producing immune cells, compared to a control formulation previously used in clinical trials. Preliminary safety assessments also indicated that the vaccine administered to mice was well tolerated.
The clinical development plan includes completing more detailed safety and immunogenicity data over the next few months to support a potential future investigational new drug (IND) regulatory filing with the FDA. The clinical plan foresees a seamless transition from the Phase I into the Phase II.
DPX-Survivac uses Survivin-based antigens, in-licensed from Merck KGaA on a worldwide exclusive basis, and formulated in the DepoVax(TM) vaccine delivery platform. Survivin is a major tumor-associated antigen over-expressed in ovarian cancer cells, making it a viable target for immunotherapy. DepoVax will deliver the Survivin-based antigens in a lipid-depot format designed to generate a strong and prolonged immune response.
DPX-Survivac could have broad commercial potential as a therapeutic cancer vaccine because it may potentially be explored in at least nine other solid tumors and hematological cancers. The Company intends to proceed with preclinical testing of DPX-Survivac in a broader range of cancer indications to evaluate additional opportunities.
About Ovarian Cancer
Ovarian cancer is the deadliest of all female cancers. According to the National Cancer Institute, over 200,000 women are diagnosed with ovarian cancer each year across the world, and it accounts for some 125,000 deaths per year. Ovarian cancer has a high mortality rate, as most cases are discovered at an advanced stage where the efficacy of current treatments is limited. It is estimated that approximately $2.2 billion is spent in the U.S. each year on treatment of ovarian cancer.(1)
(1) Cancer Trends Progress Report (http://progressreport.cancer.gov), in 2004 dollars, based on methods described in Medical Care 2002 Aug;40(8 Suppl):IV-104-17.
About Immunovaccine Inc.
Immunovaccine Inc. is a clinical stage vaccine development company focused on the commercialization of its patented DepoVax(TM) 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.
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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Dr. Marc Mansour, Vice President R&D, Immunovaccine Inc.
T: (902) 492-1819 E: [email protected] <:[email protected]>
Jennifer Ayotte, Communications, Immunovaccine Inc.
T : 902-492-1819 E: [email protected] <:[email protected]>
Andrew Mielach, Tiberend Strategic Advisors, Inc.
T: (212) 827-0020 E: [email protected] <:[email protected]>