Immunovaccine Vaccinates First Patient in Phase I Trial of the DPX-Survivac Cancer Vaccine
HALIFAX, NOVA SCOTIA -- (MARKET WIRE) -- 01/04/12 -- Immunovaccine Inc. (TSX VENTURE: IMV) today announced the first patient has been vaccinated with DPX-Survivac, a therapeutic cancer vaccine. The goal of the Phase I clinical trial is to establish the safety and immune activity of DPX-Survivac in patients with ovarian cancer.
The DPX-Survivac Phase I and II clinical trials have been cleared by both the U.S. FDA and Health Canada. DPX-Survivac is a survivin-targeting vaccine formulated in the DepoVax™ platform, a patented vaccine delivery and method that is expected to enhance the immunogenicity of the survivin antigen used in DPX-Survivac. The survivin antigen contained in the vaccine is a broadly expressed, tumor-associated antigen shown to sustain the survival of cancer cells. In combination with the DepoVax platform, it is expected to stimulate the immune system to destroy cancer cells expressing survivin and delay cancer recurrence.
DPX-Survivac will be administered to patients after debulking surgery and chemotherapy treatments. Vaccinated patients will also receive an immune modulating drug to further enhance the activity of the vaccine.
"We believe this is the right vaccine being administered at the right time," commented Dr. Mansour, Chief Science and Operating Officer. "Applying our DepoVax enhanced vaccine after surgery and chemotherapy is when therapeutic cancer vaccines are expected to be most effective."
About the Clinical Trial
The Phase I portion of the DPX-Survivac clinical trial is an open-label, dose-ranging study, enrolling up to 15 patients with stage IIc-IV ovarian cancer. Preliminary safety results, established from the first three patients, are expected in Q1/Q2 2012. Completion of patient enrollment in the Phase I study, along with a broader assessment of the vaccine's safety and immune activity is estimated to be completed by Q4 2012.
Following the completion of the Phase I clinical trial, Immunovaccine is cleared to initiate, without any further application to the U.S. FDA or Health Canada, a randomized, double-blinded, placebo-controlled Phase II clinical trial, with a selected vaccine dose. The Phase II trial will assess the clinical benefit of DPX-Survivac in patients with advanced ovarian cancer. For more details visit www.clinicaltrials.gov.
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.
Several investigator-driven clinical trials have shown that a survivin-based vaccine is capable of generating an immune response and providing a potential therapeutic benefit. In preparation for human trials with DPX-Survivac, Immunovaccine was able to show that its DepoVax platform raises a significantly higher survivin-specific immune response in animal models compared to the vaccine formulation previously used in clinical trials.
Proof-of-Concept in Ovarian Cancer
DPX-Survivac is a therapeutic vaccine applicable to multiple cancers, such as breast, colon and lung cancers, as well as hematological malignancies and melanoma. Immunovaccine has chosen to conduct clinical proof-of-concept for DPX-Survivac in ovarian cancer because of the limited treatment options and the presence of survivin in up to 90% of ovarian cancers. There is also the ability to apply the DPX-Survivac vaccine in a patient population with initial minimal residual disease, post the current standard of care, but known to have a high rate of recurrence within an average of 18 months.
About Ovarian Cancer
Ovarian cancer has the highest mortality of all cancers of the female reproductive system. This reflects, in part, a lack of early symptoms and lack of ovarian cancer screening tests. Ovarian cancer is often diagnosed at an advanced stage (III and IV), after the cancer has spread beyond the ovary. It is estimated that approximately $2.2 billion is spent in the U.S. each year on treatment of ovarian cancer.
Immunovaccine Inc. develops vaccines formulated in its vaccine enhancement platform for cancer and infectious disease. The Company's DepoVax™ platform is a patented lipid delivery system presenting antigens plus adjuvant to the immune system in a unique depot. This is expected to allow for controlled uptake of vaccine ingredients and enhanced activation of immune cells resulting in more effective immune responses. Immunovaccine has taken its platform technology and proprietary cancer vaccine, DPX-0907, into Phase I human trials and has demonstrated its safety and immune activity 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. Pfizer Animal Health has licensed the Company's delivery technology platform to develop vaccines for livestock. Connect at www.imvaccine.com or www.twitter.com/immunovaccine
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 CSO, COO (902) 492-1819 email@example.com Immunovaccine Inc. Jennifer Cameron Director Communications (902) 492-1819 firstname.lastname@example.org www.imvaccine.com Tiberend Strategic Advisors, Inc. - Media Andrew Mielach Account Director (212) 827-0020 email@example.com
Source: Immunovaccine Inc.
Released January 4, 2012