In the Phase 1 clinical trial, hormone-naïve and hormone-independent recurrent prostate cancer patients with increasing prostate specific antigen (PSA) were treated with six intradermal injections of ProscaVax.
BATON ROUGE, La., Dec. 05, 2017 (GLOBE NEWSWIRE) -- OncBioMune (OTCQB:OBMP) (“OncBioMune” or the “Company”), a revenue-stage biopharmaceutical company engaged in the development of a proprietary immunotherapy cancer vaccine technology, targeted cancer therapies and commercialization of a portfolio of products internationally, is pleased to provide the latest data from the Company’s successfully completed Phase 1 trial of ProscaVax for prostate cancer, suggesting a durable response 31 weeks post-therapy.
In the Phase 1 clinical trial, hormone-naïve and hormone-independent recurrent prostate cancer patients with increasing prostate specific antigen (PSA) were treated with six intradermal injections of ProscaVax. ProscaVax is OncBioMune’s novel immunotherapeutic cancer vaccine consisting of a combination of prostate cancer associated PSA with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF).
As previously reported, all 20 patients enrolled in the trial completed ProscaVax therapy per protocol and completed the first follow-up at 19 weeks, with 16 of 20 patients (80%) demonstrating stable disease/no prostate cancer progression. Only four patients progressed during ProscaVax therapy (3 PSA progression and radiological progression in one patient with primary brain cancer who died from the primary disease).
15 of 16 patients with stable disease at 19 weeks have now completed additional follow-up examinations 31 weeks post-therapy. All 15 patients continued to live with stable disease / no prostate cancer progression. One patient with stable disease at 19 weeks did not complete the 31-week post-therapy visit. OncBioMune has been informed that individual enrolled in a separate clinical study, but no information on any prostate cancer progression has been reported to the Company.
Data continues to confirm there were no drug-related serious adverse events or dose-limiting toxicities resulting from ProscaVax therapy.
“I’m very excited about this data, as I can’t think of another study to have 75 percent of recurrent prostate cancer patients with rising PSA experience stable disease nearly eight months after therapy ended. Of course, that number potentially could have held at 80 percent, but we won’t bother speculating about why one patient elected to enroll in another study, as these can often be very sick cancer patients,” commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. “Now, we have to expand the therapeutic range and increase the number of patients enrolled in mid-stage research, but the data to date certainly is encouraging to provide a safe and effective treatments for the millions of men battling prostate cancer today.”
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About OncBioMune Pharmaceuticals, Inc.
OncBioMune Pharmaceuticals is a revenue-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, including a proprietary vaccine technology designed to stimulate the immune system to attack tumor cells without damaging healthy tissue. OncBioMune is also involved in drug development and commercialization internationally through our wholly-owned subsidiary, OncBioMune México, S.A. De C.V. Our lead pipeline product, ProscaVax™, is scheduled to commence two, separate mid-stage clinical trials in 2017: a Phase 2 for early-stage prostate cancer at a major Northwest U.S. university cancer research hospital and a Phase 2/3 study in Mexico for late-stage prostate cancer patients. OncBioMune has a portfolio of targeted and licensed therapies, some of which are biosimilars and generics to blockbuster drugs. OncBioMune is headquartered in Baton Rouge, LA.
Forward-Looking Statements
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Contact:
OncBioMune Pharmaceuticals, Inc.
Andrew Kucharchuk
President and Chief Financial Officer
akucharchuk@oncbiomune.com
