Contact:
At RegeneRx:
J.J. Finkelstein
jjfnk@regenerx.com
301.280.1992
or
At the Financial Relations Board:
Analyst Inquiries:
Leslie Loyet
312.640.6672
or
General Inquiries
Kathy Waller
312.640.6696
or
Media Inquiries
Tim Grace
312.640.6741 |
RegeneRx President Updates Investment Community at BIO CEO & Investor Conference RegeneRx President Updates Investment Community at BIO CEO & Investor Conference
Company Targets End of 2005 to Initiate Cardiac Clinical Trial with Tß4
February 25, 2005 — Bethesda, Md
RegeneRx Biopharmaceuticals, Inc. (OTCBB:RGRX) President & CEO, J.J. Finkelstein, updating investors at the Biotechnology Industry Organization's (BIO) 2005 CEO & Investor Conference in New York on February 24th, briefed the audience on the company's progress and stated that, "based on the recent data showing Tß4's ability to protect heart tissue, thus minimizing cardiac damage and improving cardiac function after a heart attack, we are increasing our efforts to file an IND to initiate a cardiac clinical trial before year-end." Mr. Finkelstein explained that as a result of the existing body of pre-clinical data developed for RegeneRx's dermal wound healing studies, it may be possible to accelerate the initiation of such trials. He pointed out that the company is currently planning several acute (short-term) toxicology studies specifically focused on the myocardium to supplement its existing data and intends to request a pre-IND meeting with the FDA at the earliest appropriate time.
About RegeneRx Biopharmaceuticals, Inc.
RegeneRx (www.regenerx.com) is a biopharmaceutical company developing Tß4 as a platform technology for the treatment of acute and chronic wounds and for a variety of human diseases involving tissue and organ repair under an exclusive world-wide license from the National Institutes of Health. The company holds over fifty world-wide patents and patent applications related to dermal, ocular, and internal wounds and tissue repair, including the treatment and prevention of cardiac and neurological injuries. RegeneRx recently received clearance from the U.S. FDA for its first two Phase II dermal wound healing clinical trials.
Thymosin Beta 4
Tß4 is a naturally occurring peptide present in virtually all human cells. It represents a new class of wound healing drug and is different from other wound repair factors in that it promotes endothelial cell differentiation keratinocyte migration, and down-regulates a number of inflammatory cytokines and chemokines. A key mechanism of action is Tß4's ability to regulate the cell-building protein, actin, a vital component of cell structure. Additionally, it has recently been published that Tß4 directly influences the production of laminin-5, a protein necessary for proper adhesion of certain types of mammalian cells and an important component of the wound healing process. It has also recently been reported that Tß4 can inhibit or prevent apoptosis (programmed cell death) in ocular tissue and, possibly, cardiac tissue. Researchers at the National Institutes of Health (NIH), and at other academic institutions throughout the U.S., have published numerous scientific articles indicating that Tß4 is effective in accelerating dermal and corneal wounds in several animal models, under a variety of conditions. Recently, Tß4 was the subject of a publication in the scientific journal, Nature, indicating its ability to prevent and/or repair cardiac damage in laboratory animals after a myocardial infarction (heart attack).
Safe Harbor Statement
The information in this press release may include certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements concern the Company's current expectations regarding future events, including the ongoing and prospective development of Tß4 and possible future benefits to the Company, its shareholders, and patients. Due to the nature of product development and the regulatory approval process, the forward-looking statements are subject to risks and uncertainties, including those reflected in the Company's filings with the Securities and Exchange Commission, particularly its most recent Annual Report on Form 10-KSB. The Company assumes no obligation to update or revise any forward-looking statements made herein or any other forward-looking statements made by the Company.
Back To 2005 Press Release Archives
|