MELVILLE, N.Y., Dec. 21, 2015 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (the “Company") (OTCBB: BRTX ), a life sciences company focused on stem cell-based therapies, today announced the issuance of a shareholder letter by Chief Executive Officer, Mark Weinreb, providing an update to shareholders on the Company’s progress, the text of which is below.
December 21, 2015
Dear Fellow Shareholders:
With your support, we have made significant progress toward our goal of offering therapeutic products and medical therapies, using cell and tissue protocols, in the treatment of disc/spine disease and metabolic disorders. We believe that our scientific programs have great market potential and our management team and Board of Directors remain committed to meeting our goals.
I am writing to update you on the Company’s progress and let you know how we are positioning BioRestorative Therapies, Inc. going forward. We appreciate your patience and loyalty as we continue to grow.
As you know, the Company has two dynamic cell-based therapeutic programs: our Disc/Spine Program to treat chronic lumbar disc disease (bulging and herniated spinal discs) and our ThermoStem ® Program to treat metabolic disorders (such as diabetes). As an indication that we are continuing to push forward on these two programs, I would like to provide you with an update on some of our accomplishments:
Disc/Spine Program
- We have obtained a worldwide (except Asia and Argentina) exclusive license to utilize or sublicense a method for the hypoxic (low oxygen) culturing of cells for use in treating, among other things, disc and spine conditions, including protruding and bulging discs.
- We have developed our lead cell therapy product candidate, brtxDISC™.
- We have participated and had a successful pre-investigational new drug (IND) application meeting with the FDA, with regard to brtxDISC and are preparing for an IND submission to the FDA.
- Institutional review board-approved human studies were undertaken with regard to our licensed culturing technology with success rates and no known adverse results.
- We have assembled a management team with significant biotechnology expertise, including the President of our Disc/Spine Division who additionally has cell therapy and regulatory experience.
- We have engaged a Chief Medical Advisor for Spine Medicine who is an Assistant Professor at Weill Medical College of Cornell and who established the Physiatry Department at the Hospital for Special Surgery.
- We have also engaged highly experienced FDA consultants in connection with our contemplated clinical trials.
- We have established a new laboratory in Melville, New York to be used for research purposes and the possible development of cellular-based treatment protocols.
- We are currently seeking clean room certification with regard to a newly fabricated portion of our laboratory.
- We have licensed a curved needle device, patented in August 2015, designed to deliver cells and/or other therapeutic products or material to, among other possible difficult-to- locate regions of the body, the spine and discs.
Metabolic Program (ThermoStem ® )
- We have established a relationship with Pfizer with regard to a joint study of the development and validation of a human brown adipose (fat) cell model.
- Our research with regard to the identification of a population of brown adipose derived stem cells was published in Stem Cells , a respected stem cell journal.
- We have established an extensive and unique human brown adipose library.
- We have undertaken pre-clinical animal studies with regard to brown adipose tissue pursuant to which metabolic impact (weight loss; reduced glucose levels) has been observed in mice.
- We have begun to evaluate encapsulation technology for potential use as a cell delivery system for our metabolic program.
- We have entered into a research collaboration agreement with the University of Pennsylvania with regard to the understanding of brown adipose biology and its role in metabolic disorders.
- A United States patent related to the ThermoStem® Program issued in September 2015.
In addition, we have added two distinguished persons to our Board of Directors. Recently, Mr. John Desmarais joined our Board. Mr. Desmarais is the founding partner of Desmarais LLP, an intellectual property trial boutique, and the founder and owner of Round Rock Research LLC, a patent licensing company. Mr. Desmarais' $1.5 billion judgment for Alcatel-Lucent against Microsoft was one of the largest plaintiff's jury verdicts in a patent infringement action. We believe that Mr. Desmarais will be a valued member of our Board. Earlier this year, we were pleased to announce the appointment of Charles S. Ryan, J.D., Ph.D. to our Board. Dr. Ryan is an experienced senior executive with an impressive background in the pharmaceutical and biotechnology industries. Currently, Dr. Ryan is Vice President, General Counsel for Cold Spring Harbor Laboratory, a preeminent international research institution in New York.
We have also added a new member to our Scientific Advisory Board, which includes a Professor of Medicine at the Harvard Medical School and the Dana-Faber Cancer Institute, the Director of Endovascular and Minimally Invasive Image Guided Neurosurgery at George Washington University Medical Center and the former Director of Quality Assurance for the FDA’s Center for Biologics Evaluation and Research.
Looking forward, we believe that 2016 will be a landmark year. We are committed to developing our programs and anticipate making an IND submission this year to the FDA with regard to our Disc/Spine Program. We will continue to focus on bringing our products to market as quickly as possible. We will also continue to seek to solidify our relationships within the industry, including with Pfizer, and build upon our existing strong research collaborations with academic leaders, including the University of Pennsylvania. We will keep you apprised of our business developments.
Visit our website at www.biorestorative.com to receive all future shareholder updates and notifications.
Thank you for your loyalty and ongoing support.
I wish you and all those near and dear to you a wonderful Holiday Season and the very best for 2016 and beyond.
Very truly yours,
Mark Weinreb, CEO
About BioRestorative Therapies, Inc.
BioRestorative Therapies, Inc. ( www.biorestorative.com ) develops therapeutic products and medical therapies using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders:
- Disc/Spine Program: Our lead cell therapy candidate, brtxDISC™ (Disc Implanted Stem Cells), is a product formulated from autologous (or a person’s own) cultured mesenchymal stem cells collected from the patient’s bone marrow. We intend that the product will be used for the non-surgical treatment of protruding and bulging lumbar discs in patients suffering from chronic lumbar disc disease. The treatment involves collecting a patient’s own stem cells, culturing and cryopreserving the cells, and then having a physician inject brtxDISC™ into the patient’s damaged disc in an outpatient procedure. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery.
- Metabolic Program (ThermoStem®): We are developing an allogeneic cell-based therapy to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (“BAT”). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in the body may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes. The Company is a party to a research agreement with Pfizer with regard to the study of brown fat.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including those set forth in the Company's Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.
Contact: Tony Schor Investor Awareness, Inc. for BioRestorative Therapies +1 847 9452222 tony@investorawareness.com
