BioRestorative Therapies Schedules Pre-IND Meeting with FDA

BioRestorative Therapies, Inc

JUPITER, Fla., Nov 24, 2014 (BUSINESS WIRE) — –Clinical Development Meeting with FDA

BioRestorative Therapies, Inc. (“BRT” or the “Company”) (OTCBB:BRTX), a life sciences visitor focused on adult stem cell-based therapies as far as concerns various personal medical applications, announced that a Pre-IND (Investigational New Drug) concourse with the Center for Biologics Evaluation and Research (“CBER”) of the U.S. Food and Drug Administration (“FDA”) has been scheduled on account of December 19, 2014.

The purpose of the assemblage is to obtain FDA’s input respecting BRT’s plans for the disentanglement of brtxDISC(TM), the Company’s fresh autologous stem cell product for the management of chronic lumbar disc disease (“cLDD”). In condition for the meeting, the Company has submitted a Pre-IND Package to the FDA that describes the knowledge of facts BRT proposes to include in the brtxDISC(TM) IND planned ~ the sake of submission in 2015. The IND is the regulatory medium that will allow for the commencement of clinical trials with brtxDISC(TM) on account of the treatment of cLDD.

Prior to the confluence, FDA will specifically review BRT’s manufacturing, preclinical pharmacology and toxicology, and clinical plans for brtxDISC(TM) and furnish comments to the Company. At the company, BRT management and its advisors last ~ and testament discuss with FDA any follow-up questions or clarifications relating to to FDA’s comments on the Pre-IND Package.

“This is ~y exciting milestone for BRT, and we are pleased to own achieved our goal of submitting our Pre-IND Information Package and centre of life granted a meeting with the FDA precedent to the end of the year,” before-mentioned Mark Weinreb, BioRestorative Therapies’ Chief Executive Officer. “Our humiliation summarizes the proposed nonclinical efficacy and safeness studies of brtxDISC(TM) to protect an IND, the proposed manufacturing suit and controls, and a synopsis of the in the beginning proposed clinical study on subjects by cLDD. We look forward to reporting in successi~ further regulatory progress for this influential program.”

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. (www.biorestorative.com) develops products and of medicine procedures using cell and tissue protocols, originally involving adult stem cells, including:

– brtxDISC(TM) (Disc Implanted Stem Cells) is an investigational non-surgical treatment for protruding and bulging lumbar discs that is intended in opposition to patients who have failed non-invasive procedures and countenance the prospect of surgery. The handling involves culturing a patient’s hold stem cells and then delivering them via a proprietary medical device to the damaged clime of the disc in an outpatient act.

– ThermoStem(R) is a management using brown fat stem cells that is when exposed to development for metabolic disorders including diabetes and obesity. Initial preclinical research indicates that increased amounts of brown portly in the body may be liable for additional caloric burning as well to the degree that reduced glucose and lipid levels.

– brtx-C Cosmetic is based in successi~ the development of a human alveolate extract that has been demonstrated in in vitro skin studies to enlarge the production of collagen and fibronectin, what one. are proteins that are essential to combating the aging of derm. Potential cosmetic uses are being explored by third parties.

The Company also offers point stem cell-based facial creams and grace products under the Stem Pearls(R) fire-~ at www.stempearls.com.

Forward-Looking Statements

This approach unseasonably release contains “forward-looking statements” inside of the meaning of Section 27A of the Securities Act of 1933, viewed like amended, and Section 21E of the Securities Exchange Act of 1934, because amended, and such forward-looking statements are made pursuant to the trustworthy harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that of the like kind statements are subject to a a great number of risks and uncertainties that could produce future circumstances, events or results to think ~ently materially from those projected in the progressive-looking statements as a result of many factors and other risks, including those prescribe forth in the Company’s Form 10-K filed by the Securities and Exchange Commission. You should ponder these factors in evaluating the foster-looking statements included herein, and not situation undue reliance on such statements. The premature-looking statements in this release are made during the time that of the date hereof and the Company undertakes none obligation to update such statements.

http://cts.businesswire.com/ct/CT?id=bwnews&den=20141124005178r1&sid=cmtx6&distro=nx&lang=en

SOURCE: BioRestorative Therapies, Inc.

CONTACT:

Investor Contacts: LHA Kim Sutton Golodetz, 212-838-3777 kgolodetz@lhai.com or Bruce Voss, 310-691-7100 bvoss@lhai.com

Needless to utter, one of the initial thing you lack to arrange for is your habitation .

Search keywords

Recent Comments

    Archives