On January 10, 2018 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary immunotherapy cancer vaccine technology and targeted cancer therapies, reported the latest follow-up data from the Company’s Phase 1a trial of ProscaVax for prostate cancer (Press release, OncBioMune Pharmaceuticals, JAN 10, 2018, View Source [SID1234523118]). ProscaVax is OncBioMune’s novel immunotherapeutic cancer vaccine consisting of a combination of prostate cancer associated prostate specific antigen (PSA) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF).
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In the trial, 20 hormone-naïve and hormone-independent recurrent prostate cancer patients with increasing PSA were treated with six intradermal injections of ProscaVax.
The latest data shows:
14 of 20 (70%) patients have increased PSA Doubling Time (PSADT – the time for serum PSA to double its value and a key metric of disease progression) post-initiation of ProscaVax immunotherapy. This demonstrates a slowing of tumor growth at a minimum of 31 weeks post-initiation of ProscaVax immunotherapy.
15 of 18 patients have increased immunity to PSA at 31 weeks post-initiation of ProscaVax immunotherapy.
Of the 20 patients that completed ProscaVax immunotherapy, 4 patients have shown disease progression at 31 weeks and one patient has chosen to withdraw from the study after week 19 without progression and entered another clinical trial.
As a subset, of the four patients that demonstrated disease progression at 31 weeks, 3 did not have an increase in their PSADT.
"This data continues to build upon an impressive data set from the study indicating that ProscaVax is inhibiting prostate cancer progression in patients that have failed today’s standard therapies. There is a body of evidence in relapsed and advanced prostate cancer patients that slowing the velocity of PSA increase and therefore increasing PSA doubling time has a significant impact on improving prognoses," commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "In my view, not only would a therapy that can increase PSADT in a majority of patients obviously be extremely valuable in the therapeutic sense, but there is the possibility that monitoring PSADT can help identify patients that may require additional more aggressive treatment regimens due to inability to decrease PSA velocity. We look forward to mid-stage studies to better understand the clinical benefit of ProscaVax and the opportunity to improve clinical care in this area of unmet medical need."
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