Title: A Phase 2, Randomized Study of Proscavax, a PSA/IL-2/GM-CSF Vaccine, in Treatment-naive Patients with Clinically Localized Prostate Cancer Versus an Active Surveillance Strategy
Brief Summary: This study will evaluate the safety and efficacy of a prostate cancer vaccine named Proscavax(Prostate-specific antigen(PSA) / Interleukin-2(IL-2) / Granulocyte-macrophagecolony-stimulating factor(GM-CSF)) in patients with localized prostate cancer. The goal ofthe study is to determine if vaccine administration results in a change in the rate of prostate cancer progression when compared to a no-treatment control group of active surveillance patients. The researchers are interested in evaluating the proportion of participants with prostate cancer progression at 2 years following administration of Proscavax or active surveillance, the effect of the vaccine on prostate-specific antigen (PSA) doubling time and the assessmentof adverse events in these patients. Eligible patients in this study will include men who are 18 years and older and who have a previously untreated early stage prostate cancer regardless of the date of diagnosis.
PI: Rupal Bhatt, MD,PhD
Dept: Hematology/Oncology
Study Start: 2/28/2019
End: 2/28/2021
Status: OPEN TO ACCRUAL
Study Type: Interventional
Protocol Type: Treatment
Phase: II
For information about trial 18-076, please contact Cancer Clinical Trials Info at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
The FDA site hasn't been updated to recruiting yet. Just an admin thing imo.
As submitted, the Phase 2 clinical protocol will randomly enroll 120 early-stage prostate cancer patients with 40 patients on standard active surveillance and 80 patients receiving ProscaVax. The patients’ PSAs and yearly biopsies will be monitored for disease progression. The follow-up of the patients will be for two years. The investigators are Dr. Rupal Bhatt, Dr. Glenn Bubley and Dr. David Einstein at Beth Israel Deaconess Medical Center of Harvard Medical School. Early clinical research of ProscaVax, including a Phase 1 study in PSA progressing prostate cancer in hormone-naïve and hormone-independent patients, has shown ProscaVax to be well tolerated with a strong safety profile. Data from late-stage patients further shows signs of efficacy with respect to an increased immune response and slowing tumor progression.
“We are very excited to move forward on a trial for patients on Active Surveillance for prostate cancer. Immune therapies have shown promise across many fields in oncology and we hope that ProscaVax™ can show activity in patients with low risk prostate cancer,” said Dr. Rupal Bhatt.
Study Officials: Rupal S Bhatt, MD, PhD Principal Investigator
Harvard Medical Faculty Physicians Practice
Locations: United States, Massachusetts
Beth Israel Deaconess Medical Center Boston, Massachusetts, United States, 02215-5400 Contact: Rupal S Bhatt, MD, PhD Principal Investigator: Rupal S Bhatt, MD, PhD Sub-Investigator: Glen Bubley, MD Sub-Investigator: David Einstein, MD
Dana Farber Cancer Institute Boston, Massachusetts, United States, 02215 Contact: Lauren Harshman, MD Principal Investigator: Lauren Harshman, MD
Proscavax has the most potential in the pipeline and will be starting Phase 2 clinical trials at BIDMC (Harvard Medical) and UCNT (Urinary Clinic of North Texas):
They were listed at OTCQB, but due to acquiring and then retracting a deal with Vitel this resulted in a most likely temporary downgrade to Pink, I'm expecting the up-listing back to OTCQB soon.
The Company has developed a therapeutic cancer vaccine for prostate cancer patients using similar techniques developed for breast cancer patients. It is tested and laboratory proven and could become the standard of care for prostate cancer treatment. The Company incorporates scientifically proven and clinically validated treatments for cancer. We utilize patented technology developed and or acquired by OncBioMune. The intellectual property consists of multiple technologies combined with laboratory and clinical procedures that provide new insight into the treatment of cancer. The Company’s proprietary technology provides the necessary tools for the successful treatment of patient’s with a therapeutic vaccine. It is marketable and would be very profitable upon FDA approval.
The Company has data from a phase 1/2 clinical trial of their therapeutic prostate cancer vaccine. Patients with prostate cancer confirmed by biopsy and with an elevated PSA received the vaccine. We enrolled 12 patients in this study. All patients received their initial course of six vaccinations containing prostate specific antigen and biological adjuvant. Serum PSA concentrations were determined before initiating vaccination and 3-4 weeks after the 6th vaccination. Two-thirds of the prostate cancer patients’ PSAs decreased after vaccination. During the trial the prostate cancer patients received no other concurrent therapy (surgery, hormone, radiation, radioactive seeds, chemotherapy), and have additionally received three further vaccinations alternated with low dose IL-2 for the 6 months following the initial vaccinations. The Company developed the protocol for the vaccination of prostate cancer patients using techniques developed for vaccination of breast cancer patients. We are currently in a Phase 1 clinical trial at UCSD Medical School under an IND from the FDA with funding from the US Navy Cancer Vaccine Program. If proven effective clinically, it could become the standard of care for prostate cancer.
OncBiomune's ProscaVax phase 2 trial investigators Beth Israel Deaconess Medical Center of Harvard Medical School...
Glenn J. Bubley, MD, Director of Genitourinary Oncology Dr. Glenn Bubley is a renowned expert in genitourinary (GU) medical oncology with a primary focus on prostate cancer. As director of the multidisciplinary genitourinary cancer program involving medical, surgical and radiation oncologists as well as pathologists and basic scientists, he heads numerous clinical/translational trials. He is Co-Principal Investigator for the prestigious Prostate SPORE (Specialized Programs of Research Excellence) at the Dana Farber/Harvard Cancer Center. The research is a pilot of the development of an anti-prostate cancer agent specifically targeted to prostate cancer cells. He oversees the Hershey Family Prostate Cancer Tissue Bank and Data base at BIDMC, which has more than 1,000 specimens from prostate cancer patients over the past 13 years and directs interventional research for GU oncology as well, overseeing approximately 13 open trials for patients with prostate or bladder cancer. Dr. Bubley has authored numerous scientific, research and translation papers and articles in his area of expertise, prostate cancer. He serves as at BIDMC and is Associate Professor of Medicine at Harvard Medical School.
Rupal Bhatt, MD, PhD, MMS Dr. Rupal Bhatt is Assistant Professor of Medicine at Harvard Medical School, an attending physician in the GU Oncology Program and researcher Dr. Bhatt currently cares for patients with prostate, bladder and testis cancer and has participated in clinical trials in these fields. Dr. Bhatt focuses her research on Renal Cell Carcinoma and Prostate Cancer with a special interest in the Mechanisms of Resistance to Antiangiogenic Therapy. For this work, she was awarded Young Investigator Awards from AACR and ASCO and was also was awarded the ASCO Career Development Award. Currently Dr. Bhatt is in the second year of her five-year Mentored Clinical Scientist Development Award from the National Cancer Institute designed to train clinicians committed to a career in laboratory or field-based research or to translational research with a laboratory focus.
She completed her medical training and graduate training at Cornell University Medical College and The Rockefeller University, where she received her MD/PhD degrees. She trained at BIDMC as an intern and resident and began her research at BIDMC as well as joining the Hematology and Oncology Fellowship program and was recruited to join the medical staff as an attending physician in 2006. In addition to her clinical work and research Dr. Bhatt received her Masters of Medical Science during her participation in the Clinical Investigator Training Program in 2008.
David Johnson Einstein, MD Oncology Boston, MA Genitourinary Oncology, Hematologic Oncology, Hospice & Palliative Fellow, BIDMC
Office Address 800 Washington St Boston, MA 02111Phone:(617) 667-2100
Title Clinical Fellow in Medicine (EXT) Institution Beth Israel Deaconess Medical Center Department Medicine Address Beth Israel Deaconess Medical Center Department of Medicine - Rabb 430 330 Brookline Ave Boston MA 02215 Phone 617/667-9278 Fax 617/975-5009 Email
Education & Training Tufts Medical CenterTufts Medical Center
Residency Tufts University School of MedicineTufts University School of Medicine Medical School
Other Training Certifications & Licensure MA State Medical LicenseMA State Medical License 2011 - 2017 American Board of Internal Medicine Internal Medicine
Awards, Honors, & Recognition Merit Award in Palliative Care Conquer Cancer Foundation of ASCO, 2014 Excellence in Teaching Award Tufts University School of Medicine, 2014 Notable Teaching Citation Tufts Medical Center Department of Medicine, 2013
Publications & Presentations PubMed Improving End-of-Life Care: Palliative Care Embedded in an Oncology Clinic Specializing in Targeted and Immune-Based Therapies. Einstein, D. J.,DeSanto-Madeya, S.,Gregas, M.,Lynch, J.,McDermott, D. F.,Buss, M. K.; J Oncol Pract. 2017 Jun 01. Against "Healthy Paternalism" at the End of Life-Reply. Mathew P, Einstein DJ, Ladin K; JAMA Oncol. 2016-06-01. The Ethical Imperative of Healthy Paternalism in Advance Directive Discussions at the End of Life. Einstein, D. J.,Ladin, K.,Mathew, P.; JAMA Oncol. 2016 Feb 26.
Journal Articles The ethical imperative of healthy paternalism in advance-directive discussions at the end of life Einstein DJ, Ladin K, and Mathew P, JAMA Oncol, 1/25/2016 Dying for advice: code-status discussions between resident physicians patients with advanced cancer-a national survey Einstein DJ, Einstein KL, and Mathew P, J Palliat Med, 1/1/2015 A problematic palsy: an exercise in clinical reasoning Einstein DJ, Trowbridge RL, and Rencic J, J Gen Int Med, 1/1/2015
Abstracts/Posters "Expanded Prostate Cancer Index Composite-26 Online: Validation of an Internet-Based Instrument for Assessment of Health-Related Quality of Life after Treatment for Lo... Einstein DJ, American Urological Association Annual Meeting, San Diego, CA, 1/1/2016 "Dying for advice: code-status discussions between resident physicians patients with advanced cancer-a national survey." Einstein DJ, ASCO Palliative Care in Oncology Symposium, Boston, MA, 1/1/2014 Lectures "'Who Am I to Say?' The Role of Residents in Advance Care Planning." Boston, MA - 1/1/2016
Press Mentions Peuxvn4ujpboexs1qudvDigital Journal June 2017
OncBioMune Signs Letter of Intent to Initiate Phase 2 Trial of ProscaVax for Advanced Prostate Cancer with Urology Clinics of North Texas
BATON ROUGE, La., Feb. 05, 2018 (GLOBE NEWSWIRE) -- OncBioMune Pharmaceuticals, Inc. (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, is pleased to announce the signing of a Letter of Intent with Urology Clinics of North Texas (UCNT) for the purpose of initiating a Phase 2 Clinical Trial of ProscaVax in advanced prostate cancer patients. 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).
Dr. James S. Cochran, M.D., D.A.B.U., F.A.C.S., UCNT Medical Director, has agreed to serve as the trial’s Principal Investigator. Dr. Cochran has over 30 years of clinical practice experience and has participated in and provided oversight in more than 300 clinical trials.
Dr. James S. Cochran, M.D., D.A.B.U., F.A.C.S Diplomate, American Board of Urology Fellow, American College of Surgeons
Dr. Cochran is board-certified in urology and provides diagnosis and treatment of male and female urological conditions.
Medical School: •University of Texas Southwestern Medical School Dallas, Texas 1970
Residency: •Urology, University of Texas Southwestern Medical School Affiliated Hospitals include Parkland Memorial Hospital, Dallas; V. A. Hospital; Children's Medical Center; Baylor University Medical Center *Includes one year of general surgery Dallas, Texas 1971 - 1976
Other Education: •Rice University, B.A. Biology Houston, Texas 1966
Internship: •Internal Medicine, Parkland Memorial Hospital, Dallas, Texas - July 1970 through June 1971
Fellowship: •The University of Texas Southwestern Medical School Department of Cell Biology, Dallas, Texas June 1973 to July 1974
CRO news The Company is pleased to report that initial installments for the study have been made and the final preparations culminating in enrollment are being completed between Theradex Oncology, the Contract Research Organization overseeing the study, and the host hospital, Beth Israel Deaconess Medical Center, a teaching hospital of Harvard University Medical School in Boston, MA.
OncBioMune Initiates Phase 2 Clinical Trial of Novel Vaccine as Front-Line Treatment for Prostate Cancer
BATON ROUGE, La., Sept. 27, 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, today provides a status update on the Phase 2 clinical trial of ProscaVax for early-stage prostate cancer. The Company is pleased to report that initial installments for the study have been made and the final preparations culminating in enrollment are being completed between Theradex Oncology, the Contract Research Organization overseeing the study, and the host hospital, Beth Israel Deaconess Medical Center, a teaching hospital of Harvard University Medical School in Boston, MA.
In preparation for the trial and other pipeline developments, the Company has taken measures to clean its balance sheet, including recently retiring $900,000 in convertible, floorless debt. Management is currently in negotiations with its lenders and accredited investors to secure additional funding structured under attractive terms, including preferred stock and fixed-rate convertible debentures.
Not sure about the videos. If you would, reply to this post with them.
GLTA $OBMP!!
"Perfection is not attainable, but if we chase perfection we can catch excellence." Vince Lombardi Do your research! Play the TA. All posts are my opinion.
