Theralink Technologies Inc (THER)

[BooDog]

Short on time so just putting this here for follow up.

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/

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.




Has the FDA approved any cancer treatment vaccines?


In April 2010, the FDA approved the first cancer treatment vaccine. This vaccine, sipuleucel-T (Provenge®), is approved for use in some men with metastatic prostate cancer. It is designed to stimulate an immune response to prostatic acid phosphatase (PAP), an antigen that is found on most prostate cancer cells. In clinical trials, sipuleucel-T increased the survival of men with a certain type of metastatic prostate cancer by about 4 months (13).

Unlike some other cancer treatment vaccines, sipuleucel-T is customized to each patient. The vaccine is created by isolating immune system cells called dendritic cells, which are a type of antigen-presenting cell (APC), from a patient’s blood through a procedure called leukapheresis. These cells are sent to the vaccine manufacturer, where they are cultured together with a protein called PAP-GM-CSF. This protein consists of PAP linked to a protein called granulocyte-macrophage colony-stimulating factor (GM-CSF). The GM-CSF stimulates the immune system and enhances antigen presentation.

APC cells cultured with PAP-GM-CSF constitute the active component of sipuleucel-T. The cells are returned to the patient’s treating physician and infused into the patient. Patients receive three treatments, usually 2 weeks apart, with each round of treatment requiring the same manufacturing process. Although the precise mechanism of action of sipuleucel-T is not known, it appears that the APCs that have taken up PAP-GM-CSF stimulate T cells of the immune system to kill tumor cells that express PAP.

In October 2015, the FDA approved the first oncolytic virus therapy, talimogene laherparepvec (T-VEC, or Imlygic®) for the treatment of some patients with metastatic melanoma that cannot be surgically removed. In addition to infecting and lysing cancer cells when injected directly into melanoma tumors, T-VEC induces responses in non-injected lesions, suggesting that it triggers an antitumor immune response similar to those of other anticancer vaccines.

https://www.cancer.gov/about-cancer/causes-prevention/vaccines-fact-sheet

https://www.cancer.gov/Common/PopUps/popDefinition.aspx?id=CDR0000044058&version=Patient&language=English