On July 22, 2014 OBI Pharma reported hat it has completed patient enrollment in its Phase 2/3 clinical trial evaluating the safety and efficacy of its lead compound, OBI-822, an active immunotherapy for the treatment of metastatic breast cancer (Press release OBI Pharma, JUL 22, 2014, View Source;fn=news_content&no=11 [SID:1234501492]).

"Completing enrollment in the Phase 2/3 clinical trial is a major milestone in the development of OBI-822", said Michael N. Chang, Ph.D., Chairman of the Board of OBI. "Our next target is a global phase 3 trial – now that there is a current IND with the US FDA and an IND application already submitted in China. We look forward to the results of this trial being confirmed once the course of treatment is completed in all enrolled patients early next year."

"The cancer active immunotherapy, OBI-822 guides the immune system to attack breast cancer cells, with minimal side effects, [as observed in the OBI’s Phase 1 and Phase 2/3 clinical trials]" said Amy Huang, General Manager of OBI. "OBI-822’s anti-cancer potential goes beyond breast cancer. All tumor cells expressing Globo series glycan (Globo H, SSEA-3 and SSEA-4) are possible treatment targets for OBI-822. According to the latest research findings reported by Taiwan’s Academia Sinica, the Globo H vaccine can potentially treat up to 16 different types of cancer. In fact, OBI Pharma and Mackay Memorial Hospital jointly initiated a Phase 2 ovarian cancer trial in November 2013 which is currently on-going."

Earlier clinical results
Phase 1 studies of the OBI-822/OBI-821 combination conducted at MSKCC induced both IgM and IgG responses demonstrating that Globo H-specific antibodies can effectively induce complement-mediated cytotoxicity as well as antibody-dependent cytotoxicity. The most commonly observed side effects in the Phase I clinical studies of metastatic breast and prostate cancers were mild local skin reactions and minor flu-like symptoms.

Clinical Study Design
The Phase 2/3 randomized controlled trial (RCT) was initiated in December, 2010 with an enrollment target of 342 subjects. The study enrolled female subjects with metastatic breast cancer who achieved stable disease (SD), partial response (PR), or complete response (CR) after at least 1 regimen of anticancer therapy. Subjects were randomized to receive either active treatment (OPT‐822/OPT‐821) plus cyclophosphamide or control (PBS) plus cyclophosphamide in a 2:1 allocation.

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