RegeneRx Biopharmaceuticals (RGRX)
Interview with: J.J. Finkelstein, President and CEO
Business News, Financial News, Stocks, Money & Investment Ideas, CEO Interview
and Information on their proprietary product, Thymosin ßeta 4 (Tß4), for the healing of chronic wounds caused by disease, abrasion, or other pathology.

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RegeneRx Biopharmaceuticals is developing Thymosin Beta 4 (Tß4), a ground-breaking drug treatment for chronic wounds



Healthcare
Biotechnology & Drugs
(OTCBB: RGRX)

RegeneRx Biopharmaceuticals

J.J. Finkelstein
President and
Chief Executive Officer

Interview conducted by:
Lynn Fosse
Senior Editor

CEOCFOinterviews.com
July, 2003

RegeneRx Biopharmaceuticals (OTCBB: RGRX) is developing a proprietary product, Thymosin ßeta 4 (Tß4), for the healing of chronic wounds caused by disease, abrasion, or other pathology. For the past several years, the National Institutes of Health (NIH) has conducted a research program to evaluate Tß4 as a wound healing and anti-inflammatory agent. The result of this research has led to the filing of worldwide patent applications related to Tß4. Wounds fall into several categories depending on whether they are chronic or acute, or result from disease, the environment, accidents, or medical procedures. The Company has identified several significant potential markets for Tß4: Chronic bed sores, Diabetic ulcers (usually lower extremities), Wounds arising from genetic defects, Inflammatory eye injuries, Cuts and abrasions, Burns (heat and chemical) and Anti-inflammatory responses formed after laser skin resurfacing.  Mr. J.J. Finkelstein, president and CEO of RegeneRX Biopharmaceuticals describes the opportunity in the chronic wound care market, “The market itself is segmented because there are many different types of chronic wounds. It is in desperate need of a product that can help promote, repair and accelerate the healing of these wounds, which occur for various reasons.  Some become chronic, as opposed to acute or short-term, due to factors such as aging or if patients have underlying diseases such as diabetes. In these instances wounds do not heal very well or may not heal at all. Patients may have a genetic or autoimmune disorder, or they may be on steroids; all these factors can cause chronic wounds or affect their ability to heal. The market needs a product that can help accelerate the healing of wounds.  In animal models that are designed to mimic the human condition, Tß4 has shown to be quite effective in promoting wound healing and in accelerating the closure of dermal and ocular wounds.”  Mr. Finkelstein tells us that, “Tß4 regulates a protein in the body called Actin, which is the protein responsible for the movement of cells throughout the body, specifically non-muscle cells. When you have a wound, its leading edge should have an abundance of Actin and Tß4. However, if not, the wound may worsen and become chronic. Our interest is in restoring Tß4 to the wound to allow Actin to do what it is supposed to do by regulating it. This regulation of Acting, which is called polymerizing and depolymerizing, causes cells to move, aggregate and accumulate around the wound and start the closure process. Many people assume Tß4 is a growth factor but it is not; it operates on a very different level.” Addressing the issue of commercialization, Mr. Finkelstein explains, “There are many steps, and we have a very in-depth strategic plan of how we will commercialize the product, not only implementing the processes, but also financing each segment. Developing any medical product clearly requires substantial capital. We have been raising capital since I became involved in this project approximately three and a half years ago. We have a pharmaceutical partner that has taken an equity investment in our company twice now and we are looking at raising our next round of capital shortly. By the end of this year, we should have enough capital to complete several Phase II studies in the United States as well as operating capital for two to three years. Given that the capital is available, the question is, ‘how we will pursue the development of the product.’ We are independently developing Tß4 in the U.S. for dermal wounds and will do so as long as possible to create as much value as possible. We are talking to a number of companies regarding potential strategic partnerships for other areas of use outside dermal wounds, and in other territories. We are looking to have a several pronged approach; independently and through partnerships working in parallel fashion.”  RegeneRx is moving forward with Phase 1 Trial expected to be completed in August, 2003.  “I think of us as in our teen years of development – full of excitement, still some unknowns, but on our way to adulthood!  I think that this is an exciting opportunity; we certainly believe in what we are doing,” comments Mr. Finkelstein.  “The data to date have been substantial and published in well-known scientific journals by independent and prestigious research institutions. RegeneRx has operated very efficiently and effectively so far.   We are rapidly moving forward and have accomplished everything we publicly said we would accomplish over the past three and one half years, and are excited about the coming twenty-four months.”

In February 2001, the Company secured an exclusive worldwide license from NIH relating to all intellectual property covered under the patent applications. Under a research agreement with The George Washington University, the Company has exclusive rights to patents obtained from sponsored research associated with septic shock and associated syndromes including acute respiratory disease syndrome (ARDS).  Since 1999, the Company has filed numerous additional patent applications related to Tß4.

The Company's research and development effort is primarily focused on collaborating with NIH and the sponsorship of human clinical trials. Pre-clinical testing must be conducted to evaluate the potential efficacy and the safety of an investigational drug prior to its use in human clinical trials. The results of these studies are submitted to the U.S. FDA as part of an IND, which must be reviewed and approved before clinical testing can begin. Clinical evaluation involves a three-stage process. In November 2002 RegeneRx filed its first IND for Tß4, which it received in December 2002. The Company began Phase I clinical trials in the first quarter of 2003. 

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