I occasionally look another site which is predominately american and canadian users which, like ours, post info re treatment they receive etc
i saw this on their site and thought it looked interesting. Has anyone else heard of this trial?
Comtex News Network
Oct 12, 2012 (Datamonitor via COMTEX) -- Immunovaccine Inc., a clinical stage vaccine company, has reported positive interim data from the company's Phase I clinical trial of DPX-Survivac, an ovarian cancer vaccine candidate.
The ongoing Phase I study is evaluating the potency, safety and tolerability of DPX-Survivac alone or in combination with low dose oral cyclophosphamide.
Interim results showed that, to date, all nine patients receiving DPX-Survivac in combination with cyclophosphamide produced a targeted immune response following only one or two vaccine administrations. Patients receiving a higher dose (0.5 mL) of DPX-Survivac in combination with cyclophosphamide (n=3) produced immune responses after only one vaccination and generally exhibited higher antigen specific immunity than those receiving the combination with a lower (0.1 mL) DPX-Survivac dose (n=6), suggesting dose-related activity.
Importantly, patients in the two cohorts experienced consistent immune responses that were detected at two consecutive time points. Specifically, the first three patients enrolled in the 0.5 mL dose cohort in combination with low dose cyclophosphamide demonstrated an average stimulation factor of 350 times (350x) following the second vaccination, and in one patient greater than 850 times (850x), over baseline responses.
Additional results from the interim analysis showed that patients receiving DPX-Survivac without cyclophosphamide were capable of producing antigen specific immune responses. The interim analysis also showed the vaccine to be safe and well tolerated with no systemic side-effects or dose limiting toxicities reported to date.
Adverse events were limited to expected local reactions at the site of vaccination. Final results from the study, including a more extensive safety and immunogenicity analysis of all cohorts, are expected by the end of the year.
The ongoing Phase I DPX-Survivac trial is a multi-center, open-label, dose-ranging study in previously diagnosed ovarian cancer patients who have been treated by surgery and chemotherapy. Under the study protocol, these patients each receive a total of three DPX-Survivac vaccinations three weeks apart. A lead-in cohort of three patients received DPX-Survivac alone.
Two additional cohorts of six patients each received a low dose or a high dose of vaccine concurrent with a low dose of oral cyclophosphamide. The trial's primary objective is to evaluate the safety of the vaccine with and without the presence of metronomic cyclophosphamide as an immune modulator. A secondary endpoint is the evaluation of the immune response produced by the vaccine therapy.
Immunovaccine has already received clearance from FDA and Health Canada for the initiation of a Phase II trial of DPX-Survivac immediately following the completion of the ongoing Phase I study. The Phase II trial will be a randomized, double-blinded, placebo-controlled study with a single vaccine dose selected based on the Phase I results. The Phase II trial will assess the clinical benefit of DPX-Survivac in patients with advanced ovarian cancer.
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 anticancer 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.
"These interim results provide important support for the ongoing DPX-Survivac development program as they clearly demonstrate that the vaccine can activate the desired immunity in our target patient population," said Marc Mansour, chief science officer of Immunovaccine. "This offers further support of the fundamental advantages and potential of our DepoVax platform as a powerful vaccine adjuvanting technology."
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