Immunovaccine Reports Positive Interim Data from Phase I Clinical Trial of DPX-0907 in Patients With Breast, Ovarian and Prostate Cancer
HALIFAX, NOVA SCOTIA -- (MARKET WIRE) -- 04/11/11 -- Immunovaccine Inc. (TSX VENTURE: IMV), announced interim immunogenicity results for the Phase I clinical trial of its therapeutic vaccine candidate, DPX-0907. The analysis showed that the DPX-0907 vaccine elicited an antigen specific immune response in the majority of ovarian cancer patients analyzed.
"We are encouraged that DPX-0907 is well tolerated when administered at the 0.25 or 1mL dose levels. We saw an immune response in patients with breast, ovarian or prostate cancer," said Dr. Marc Mansour, Immunovaccine's Vice President of Research and Development. "The responder rate appears to be highest in patients with ovarian cancer," added Dr. Mansour.
The ongoing Phase I clinical trial of DPX-0907 is an open-label, dose-escalating evaluation of the vaccine's safety and tolerability in patients with advanced breast, ovarian or prostate cancer. Immunovaccine developed DPX-0907 with seven peptide antigens designed to target multiple cancer pathways.
Enrollment in the study has been completed. This preliminary evaluation examined vaccine responses in the first fifteen patients enrolled in the study; three with breast cancer, five with ovarian cancer and seven with prostate cancer. Immunovaccine will perform a more detailed analysis of samples collected from all patients by Q3 2011. Patients received three injections (0.25 mL or 1 mL) of the active immune therapy DPX-0907.
For this interim analysis, select blood samples collected from the first fifteen patients were examined for the presence of antigen specific CD8 T cells to indicate a vaccine induced immune response. Eight patients in the 0.25 mL dose cohort and seven patients in the 1mL dose cohort were analyzed. Antigen specific immune responses were detected in patients vaccinated with either dose levels. An increase in antigen specific CD8 T cells following vaccination was detected in the majority of ovarian cancer patients, and to a lesser extent in patients with advanced prostate or breast cancer. Among responding patients, an increase in antigen specific CD8 T cells was observed after one dose in some patients, and after two or three doses in other patients.
Adverse events related to DPX-0907 in this study were manageable and consistent with vaccine-related adverse events such as redness and tenderness at the site of injection. There were no dose limiting toxicities (DLT) reported.
About the DPX-0907
DPX-0907 is a therapeutic cancer vaccine candidate for the treatment of patients with advanced stage breast, ovarian or prostate cancer. DPX-0907 combines seven peptide antigens plus an adjuvant with Immunovaccine's DepoVax™ delivery platform. The depot effect created by the DepoVax platform is a result of a patented lipid delivery system that presents the antigens and adjuvant to the immune system for a prolonged period, and has the potential to enhance the immune response. The seven peptide antigens in DPX-0907 are believed to be present on the surface of breast, ovarian and prostate cancer cells. This novel vaccine formulation is designed to target proteins involved in critical tumor cell processes and is expected to kill tumor cells without injury to normal, healthy tissues.
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: Immunovaccine Inc. Marc Mansour, Ph.D. Vice President of R&D (902) 492-1819 firstname.lastname@example.org Immunovaccine Inc. Jennifer Ayotte Director Communications (902) 492-1819 email@example.com www.imvaccine.com Tiberend Strategic Advisors, Inc. Andrew Mielach (212) 827-0020 firstname.lastname@example.org
Source: Immunovaccine Inc.
Released April 11, 2011