BATON ROUGE, LA, USA I February 23, 2016 I OncBioMune Pharmaceuticals, Inc. (OBMP) (“OncBioMune” or the “Company”), a clinical stage biopharmaceutical company engaged in the development of novel cancer products and a proprietary vaccine technology, is pleased to report positive results from its Phase 1 clinical trial of ProscaVax, the Company’s novel cancer vaccine for prostate cancer. The trial is hosted at the University of California San Diego Moores Cancer Center and the Veterans’ Hospital, La Jolla, CA to evaluate the safety and efficacy of ProscaVax in patients with recurrent disease, defined as rising PSA after initial treatment (surgery, radiation, or brachytherapy/radioactive seeds).
The trial was originally designed as a Phase 1a/1b study with an estimated enrollment of 20 patients in the Phase 1a and 28 in the Phase 1b. Fifteen patients have been enrolled in the Phase 1a portion of the trial. Preliminary data collected from the trial to date supports data from previous clinical research, showing that ProscaVax has a very strong safety profile. No serious adverse events have ever been reported in any clinical study relating to the vaccine technology. Additional preliminary data shows ProscaVax to provide a meaningful clinical benefit to prostate cancer patients. These data include:
- 14 of 20 patients in the Phase 1a portion of the trial have received at least one vaccine injection and 12 patients have received all 6 vaccines
- None of the 14 patients who have had at least one vaccine have had a dose limiting adverse event (DLAE)
- None of the 12 patients who have received all 6 vaccines in the Phase 1a have had a DLAE
- 8 of the 12 patients (66.7%) who have received 6 vaccines have had increased immune responses to PSA as determined with a LBA
- 8 of 11 patients (72.7%) at 31 weeks post first vaccine have had an increased immune response to PSA as determined with a LBA
Based upon the lack of toxicity and compelling immunological data collected, OncBioMune is continuing the Phase 1a trial and incorporating the Phase 1b of ProscaVax into a Phase 2 trial in prostate cancer patients at presentation of the disease, rather than relapse. Over 200,000 patients will be diagnosed with prostate cancer this year. Early stage prostate cancer patients have very limited therapeutic options and no FDA approved treatments that are not accompanied by well-known high levels of morbidity.
“The Phase 1a study has provided us with what we need to move into a Phase 2 clinical trial of ProscaVax by further validating the safety of ProscaVax and signs of efficacy with respect to increase immune responses to PSA. This points us squarely at focusing on early stage prostate cancer patients, which happens to be the largest market and an area of significant unmet medical need,” commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. “To the best of our knowledge, we will be the only company evaluating a prostate cancer vaccine in a mid-stage trial for patients in the active surveillance population. We are excited about commencing the Phase 2 trial and hopeful ProscaVax can one day be the go-to therapy of choice for early stage prostate cancer patients.”
Sign up for OncBioMune email alerts at: http://oncbiomune.com/email-alerts/.
About OncBioMune Pharmaceuticals, Inc.
OncBioMune Pharmaceuticals is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, with a proprietary Vaccine Technology that is designed to stimulate the immune system to attack its own cancer while not hurting the patient. Our lead product, ProscaVax™ is scheduled to commence a Phase 2 clinical study in 2016. OncBioMune also has a portfolio of targeted therapies, some of which are biosimilars to blockbuster drugs. OncBioMune is headquartered in Baton Rouge, LA.
This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor there be any sale of these securities in any jurisdiction in which such offer solicitation or sale are unlawful prior to registration or qualification under securities laws of any such jurisdiction.
SOURCE: OncBioMune
Post Views: 24
BATON ROUGE, LA, USA I February 23, 2016 I OncBioMune Pharmaceuticals, Inc. (OBMP) (“OncBioMune” or the “Company”), a clinical stage biopharmaceutical company engaged in the development of novel cancer products and a proprietary vaccine technology, is pleased to report positive results from its Phase 1 clinical trial of ProscaVax, the Company’s novel cancer vaccine for prostate cancer. The trial is hosted at the University of California San Diego Moores Cancer Center and the Veterans’ Hospital, La Jolla, CA to evaluate the safety and efficacy of ProscaVax in patients with recurrent disease, defined as rising PSA after initial treatment (surgery, radiation, or brachytherapy/radioactive seeds).
The trial was originally designed as a Phase 1a/1b study with an estimated enrollment of 20 patients in the Phase 1a and 28 in the Phase 1b. Fifteen patients have been enrolled in the Phase 1a portion of the trial. Preliminary data collected from the trial to date supports data from previous clinical research, showing that ProscaVax has a very strong safety profile. No serious adverse events have ever been reported in any clinical study relating to the vaccine technology. Additional preliminary data shows ProscaVax to provide a meaningful clinical benefit to prostate cancer patients. These data include:
- 14 of 20 patients in the Phase 1a portion of the trial have received at least one vaccine injection and 12 patients have received all 6 vaccines
- None of the 14 patients who have had at least one vaccine have had a dose limiting adverse event (DLAE)
- None of the 12 patients who have received all 6 vaccines in the Phase 1a have had a DLAE
- 8 of the 12 patients (66.7%) who have received 6 vaccines have had increased immune responses to PSA as determined with a LBA
- 8 of 11 patients (72.7%) at 31 weeks post first vaccine have had an increased immune response to PSA as determined with a LBA
Based upon the lack of toxicity and compelling immunological data collected, OncBioMune is continuing the Phase 1a trial and incorporating the Phase 1b of ProscaVax into a Phase 2 trial in prostate cancer patients at presentation of the disease, rather than relapse. Over 200,000 patients will be diagnosed with prostate cancer this year. Early stage prostate cancer patients have very limited therapeutic options and no FDA approved treatments that are not accompanied by well-known high levels of morbidity.
“The Phase 1a study has provided us with what we need to move into a Phase 2 clinical trial of ProscaVax by further validating the safety of ProscaVax and signs of efficacy with respect to increase immune responses to PSA. This points us squarely at focusing on early stage prostate cancer patients, which happens to be the largest market and an area of significant unmet medical need,” commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. “To the best of our knowledge, we will be the only company evaluating a prostate cancer vaccine in a mid-stage trial for patients in the active surveillance population. We are excited about commencing the Phase 2 trial and hopeful ProscaVax can one day be the go-to therapy of choice for early stage prostate cancer patients.”
Sign up for OncBioMune email alerts at: http://oncbiomune.com/email-alerts/.
About OncBioMune Pharmaceuticals, Inc.
OncBioMune Pharmaceuticals is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, with a proprietary Vaccine Technology that is designed to stimulate the immune system to attack its own cancer while not hurting the patient. Our lead product, ProscaVax™ is scheduled to commence a Phase 2 clinical study in 2016. OncBioMune also has a portfolio of targeted therapies, some of which are biosimilars to blockbuster drugs. OncBioMune is headquartered in Baton Rouge, LA.
This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor there be any sale of these securities in any jurisdiction in which such offer solicitation or sale are unlawful prior to registration or qualification under securities laws of any such jurisdiction.
SOURCE: OncBioMune
Post Views: 24
