Theralink Technologies Inc (THER)

[BooDog]

Accumulating for the phase 2 kick off at Harvard. Some may want to do some dd on who's leading and involved with the upcoming trial. Personally, I'll simply take advantage as much as I can. Have a lot on my plate in the sector already but managing to shift profits around to build my positions.


This may help...

OncBiomune revenue and preparing for Phase 2 clinical trials evaluating ProscaVax in both early-stage prostate cancer at Beth Israel Deaconess Medical Center and also in late-stage prostate cancer patients in a prominent hospital network in Mexico.

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Sept. 14, 2017 OncBioMune Meets Primary Objective in Trial of ProscaVax Immunotherapy Vaccine for Prostate Cancer
http://oncbiomune.com/2017/09/14/oncbiomune-meets-primary-objective-in-trial-of-proscavax-immunotherapy-vaccine-for-prostate-cancer/


Phase 2 Trial of ProscaVax for Early-Stage Prostate Cancer Nears Commencement


BATON ROUGE, LA–(July 13, 2017) – OncBioMune Pharmaceuticals, Inc. (OTCQB: OBMP) (“OncBioMune” or the “Company”), a revenue-stage biopharmaceutical company engaged in the development of targeted cancer therapies, a proprietary cancer vaccine technology and commercialization of a portfolio of products internationally, is pleased to announce that the protocol for the planned Phase 2 trial of ProscaVax for treatment-naïve prostate cancer patients is awaiting approval from the Institutional Review Board (IRB) at the host hospital, a preeminent North-eastern U.S. cancer research network. The protocol was previously submitted to the U.S. Food and Drug Administration and received no comments within the 30-day comment period.

http://oncbiomune.com/2017/07/13/phase-2-trial-of-proscavax-for-early-stage-prostate-cancer-nears-commencement/

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Final Patient Completes Treatment in OncBioMune Clinical Trial of ProscaVax for Prostate Cancer

Thu August 24, 2017 8:32 AM|Marketwire|About: OBMP

BATON ROUGE, LA -- (Marketwired) -- 08/24/17 -- OncBioMune Pharmaceuticals, Inc. (OBMP) ("OncBioMune" or the "Company"), a revenue-stage biopharmaceutical company engaged in the development of targeted cancer therapies, a proprietary cancer vaccine technology and commercialization of a portfolio of products internationally, is pleased to announce that the 20th and final patient in the Phase 1A portion of a Phase 1 trial of ProscaVax for prostate cancer completed treatment per protocol. In the study, ProscaVax, the Company's novel immunotherapeutic cancer vaccine consisting of a combination of tumor-associated prostate specific antigen (PSA) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF), is being evaluated for safety, tolerability and efficacy in PSA-progressing prostate cancer in hormone-naïve and hormone-independent patients.

The interventional, open label trial is being hosted at the University of California San Diego Moores Cancer Center and the Veterans Hospital in La Jolla, California under an investigational new drug (IND) application from the U.S. Food and Drug Administration with funding from the U.S. Navy Cancer Vaccine Program. The original study design for the trial included a second stage, which OncBioMune has previously disclosed that it will forego due to favorable interim safety results from the 1A stage to initiate two separate Phase 2 clinical trials evaluating ProscaVax in both early-stage prostate cancer at Beth Israel Deaconess Medical Center and also in late-stage prostate cancer patients in a prominent hospital network in Mexico.

"To date, ProscaVax has been very well tolerated with no serious adverse events related to the vaccine in the trial. To that end, we are optimistic that the treatment of the final patient will continue on trend, so the study will meet its primary endpoint of no dose limiting adverse events 30 days subsequent to the last injection," commented Andrew Kucharchuk, President and Chief Financial Officer at OncBioMune. "We look forward to the final data on the primary endpoint of safety early in September and later analysis of the complete data set to look for further validation of signs of efficacy based upon increased immune responses and slowing of disease progression that was found in interim analysis."

Sign up for OncBioMune email alerts at: http://oncbiomune.com/email-alerts/.

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

This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause OncBioMune Pharmaceuticals' actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. OncBioMune Pharmaceuticals has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are OncBioMune Pharmaceuticals' need for, and the availability of, substantial capital in the future to fund its operations and research and development; the fact that OncBioMune Pharmaceutical's vaccines and therapeutics may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in OncBioMune Pharmaceutical's filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. OncBioMune Pharmaceuticals undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
Contact:OncBioMune Pharmaceuticals, Inc.Andrew KucharchukPresident and Chief Financial [e-mail]

http://at.marketwire.com/accesstracking/AccessTrackingLogServlet?prid=11G144578-001&sourceType=1
Source: OncBioMune Pharmaceuticals, Inc.

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ProscaVax – A Novel Prostate Cancer Vaccine

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.

Information on the current clinical trial of ProscaVax can be found on the clinictrials.gov at https://clinicaltrials.gov/ct2/show/NCT02058680?term=oncbiomune&rank=1.

http://oncbiomune.com/proscavax/

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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.

http://www.bidmc.org/Centers-and-Departments/Departments/Cancer-Center/Genitourinary-Oncology-Program/Meet-our-team.aspx


Thank you gmwestrup!!!

David Johnson Einstein, MD
Oncology Boston, MA
Genitourinary Oncology, Hematologic Oncology, Hospice & Palliative Fellow, BIDMC

Office Address
800 Washington St
Boston, MA 02111Phone:[phone]

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 [phone]
Fax [phone]
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



BATON ROUGE, LA—(June 01, 2017) – OncBioMune Pharmaceuticals, Inc. (OTCQB: OBMP) (“OncBioMune” or the “Company”), a clinical stage biopharmaceutical company engaged in the development of targeted cancer therapies and a proprietary vaccine technology, is pleased to announce that the protocol for the Company’s upcoming Phase 2 clinical trial of ProscaVax as a novel therapeutic cancer vaccine for early stage prostate cancer has been submitted to the U.S. Food and Drug Administration (FDA) for review. In the trial, ProscaVax will be evaluated for safety, tolerability and efficacy as a treatment for patients at disease presentation who, in collaboration with their oncologist, chose to forego standard approved therapies in favor of careful monitoring for disease progression, a process known more commonly as “active surveillance.”

ProscaVax is an immunotherapeutic cancer vaccine consisting of a combination of the tumor-associated antigen PSA (prostate specific antigen) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF).

There are currently no FDA-approved treatments for patients in active surveillance. Today’s approved therapies for early-stage prostate cancer include surgery to remove the prostate and some surrounding tissue (radical prostatectomy), radiation and brachytherapy, all of which are well documented to have unpleasant side effects, including impotence and urinary incontinence.

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 Clinical Trial that recently completed enrollment 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.

http://oncbiomune.com/2017/06/01/protocol-submitted-to-fda-for-phase-2-clinical-trial-of-proscavax-as-immunotherapy-for-early-stage-prostate-cancer/


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OncBioMune To Become Exclusive Distributor of Lipomed Drugs in Mexico

http://oncbiomune.com/2017/08/10/oncbiomune-to-become-exclusive-distributor-of-lipomed-drugs-in-mexico/

OncBioMune Acquires Propolis Product Line from German Partner

http://oncbiomune.com/2017/07/20/oncbiomune-acquires-propolis-product-line-from-german-partner/