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OncBioMune: ASCO Reinforces Market Opportunity for New Prostate Cancer Vaccine as Phase 2 Trial Approaches
OncBioMune Pharmaceuticals (OTCMKTS:OBMP) announced an update on corporate and clinical developments.
OncBioMune Pharmaceuticals (OTCMKTS:OBMP) announced an update on corporate and clinical developments.
As quoted in the press release:
Mexican Trials of ProscaVax for Prostate Cancer
OncBioMune, with its joint venture partner Vitel Laboratorios S.A. de C.V. (“Vitel”), is near commencement of a Phase 2 clinical trial of the Company’s novel cancer vaccine, ProscaVax, for the treatment of PSA (prostate specific antigen) recurrent prostate cancer in hormone-naïve and hormone-independent patients. Following successful meetings two weeks ago in Mexico with drug development authorities, parties involved in the upcoming Phase 2 trial and Vitel, OncBioMune executives have been invited next week to attend additional meetings with other scientists and venture capital funds interested in learning more about opportunities involving the trial and OncBioMune’s vaccine technology platform.
OncBioMune has also been advised that preparations for the Phase 2 trial are progressing smoothly and that patient screening and trial enrollment remains on target for the third quarter. We remain very encouraged by the support of the Mexican health authorities and guidance from Vitel that there is a clear path for expedited commercialization of ProscaVax if the trial can deliver results showing a meaningful therapeutic benefit of ProscaVax in reduction of PSA.
ProscaVax in the U.S.
A Phase 1 trial of ProscaVax in PSA recurrent prostate cancer patients is ongoing. Sixteen patients in the Phase 1a portion of the trial have been enrolled, with promising data collected to date. As previously disclosed, OncBioMune is foregoing the Phase 1b portion of the trial, instead moving directly forward with Phase 2 trials in both Mexico and the United States.
The Phase 1a trial has clearly validated previous studies in hundreds of patients showing that the vaccine platform is without toxicity. As of the last data analysis, none of the 14 patients receiving at least one ProscaVax vaccine experienced a dose limiting adverse event (DLAE). None of the 12 patients who received six ProscaVax vaccines (per protocol guidelines for completing therapy) had a DLAE. 9 of 12 patients (75%) who received six ProscaVax vaccines had increased immune responses to PSA as determined by a lymphocyte blastogenesis assay (LBA).
The latest data set from the trial is presently being analyzed. OncBioMune anticipates releasing the latest data in the coming weeks.
ASCO
Dr. Jonathan Head, Chief Executive Officer at OncBioMune, attended the American Society Of Clinical Oncology (ASCO) Annual Meeting 2016 held in Chicago, Illinois on June 3-7, 2016. OncBioMune’s abstract was published for ASCO 2016 and during his time there he meet with experts in the field of prostate cancer.
OncBioMune CEO, Dr. Jonathan Head, stated:
I came away from ASCO with further confirmation that scientists and physicians are actively looking for better therapies with fewer co-morbidities to treat prostate cancer,” commented Dr. Head. “The glaring fact that the scientific community realizes that prostate cancer patients are still being over-treated causing impotence and/or incontinence, or under-treated and simply waiting for disease progression, reinforces the need for less toxic therapies for patients at diagnosis. Obviously, neither present approach is practical or beneficial to the patient. The ASCO meeting reinforced our position more than ever that there is a tremendous market opportunity for ProscaVax, which we believe will potentially open expedited pathways to market to meet an area of great unmet medical need.
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