Company Also Announces Initial Data from Phase I Trial of DPX-Survivac in Ovarian Cancer Patients
Halifax, Nova Scotia; June 20, 2012 – Immunovaccine Inc. (“Immunovaccine” or the “Company”) (TSX-V: IMV), a clinical stage vaccine company, announced that a scientific presentation featuring the Company’s therapeutic cancer vaccine, DPX-Survivac, will be made today at the 12th annual meeting of the Federation of Clinical Immunology Societies (FOCIS), FOCIS 2012. The presentation will provide an overview of the field of combination immunotherapy and highlight Immunovaccine’s DPX-Survivac as a case study for a rationally designed combination therapy development program in the area of cancer immunotherapy. The presentation entitled “Clinical Development Considerations for Combination Therapies,” will be delivered by Neil Berinstein, M.D., director, translational research at the Ontario Institute for Cancer Research.
The case study provides an overview of the rationale guiding the design of a Phase II clinical trial of DPX-Survivac, a vaccine incorporating the broadly expressed cancer-specific antigen survivin combined with the Company’s novel adjuvanting technology, DepoVax™. The randomized, double-blinded, placebo-controlled study, which has been cleared by both the United States Food and Drug Administration and Health Canada, is designed to test DPX-Survivac in combination with low dose cyclophosphamide as a maintenance treatment for patients with advanced ovarian cancer. Dr. Berinstein will present a collection of clinical and preclinical data generated by both Immunovaccine and independent researchers that support the Company’s evaluation of this combination therapy and highlight cyclophosphamide’s expected role as a complementary immunomodulator to enhance the activity of DPX-Survivac.
DPX-Survivac is currently being tested in a multi-center open-label, dose-ranging Phase I study in ovarian cancer. The trial’s first cohort consisting of three patients given three doses of DPX-Survivac over a period of six weeks has now been completed. Results from the first cohort demonstrated that DPX-Survivac was well tolerated with no serious events reported, and that the vaccine is immunogenic as a monotherapy. The Phase I trial, designed to test the safety and immunogenicity of the combination of the vaccine with low dose cyclophosphamide, is expected to complete patient enrollment in Q3 2012 with study results expected in Q4 2012.
DPX-Survivac consists of survivin-based peptide antigens formulated in the DepoVax™ adjuvanting platform. Survivin has been recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen (TAA) because of its therapeutic potential and its cancer specificity. Survivin is broadly over-expressed in multiple cancer types in addition to ovarian cancer, including breast, colon and lung cancers. Survivin plays an essential role in antagonizing apoptosis, supporting tumor-associated angiogenesis, and promoting resistance to various anti-cancer therapies. Survivin is also a prognostic factor for many cancers and it is found in a higher percentage of tumors than other TAA’s.
The DPX-Survivac vaccine is thought to work by eliciting a cytotoxic T-cell immune response against cells presenting survivin peptides on HLA class I molecules. This targeted therapy attempts to use the immune system to actively and specifically search for and destroy tumor cells. Survivin-specific T-cells have been shown to target and kill survivin-expressing cancer cells while sparing normal cells.
Immunovaccine Inc. applies its novel vaccine delivery platform to the development of vaccines for cancer therapy and infectious diseases. The Company’s DepoVax™ platform is a patented lipid delivery system that presents antigens plus adjuvant to the immune system for a prolonged period and has the potential to enhance immune responses. Immunovaccine has advanced its platform technology and proprietary cancer vaccine into Phase I human clinical trials and has demonstrated both safety and immunogenicity potential. The Company is also capitalizing on the broad potential of its delivery platform by creating new DepoVax-based vaccines through multiple development collaborations. In addition to the Company’s human health vaccine strategy, it continues to capture value from animal health vaccine applications. Immunovaccine has several key partnerships in the animal health sector including an agreement with Pfizer Animal Health, which has licensed the Company’s delivery technology platform to develop vaccines for livestock. Connect at 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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Marc Mansour, Immunovaccine Inc.
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Nadine Desruisseaux, Capital Ideas Investor Relations (Investors – Canada)
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