By: Dylan Sikes - AllPennyStocks.com News

Thursday, August 6, 2015

According to the Mayo Clinic’s Center for Regenerative Medicine, current evidence-based and palliative treatments are increasingly unable to keep pace with patients’ needs, especially given the aging population. The Center notes that right now there are few effective ways to treat the root causes of many diseases. This is where regenerative medicine comes in. The Mayo Clinic describes regenerative medicine as a game-changing area of medicine with the potential to fully heal damaged tissues and organs. Not surprisingly, the patient and the investor communities are excited about regenerative medicine.

Of course, the concept of regenerative medicine isn’t new. According to the Center for Regenerative Medicine, the first bone marrow and solid-organ transplants were performed decades ago. However, with the advances made in the areas of developmental and cell biology, immunology, and other fields, have unlocked new opportunities to refine existing therapies, the center notes.

There are several U.S.-based biotechs currently focusing on the regenerative medicine field. One such company is Rockville, Maryland-based RegeneRx Biopharmaceuticals Inc. (OTCQB:RGRX). The company is currently in clinical-stage and focuses on tissue protection, repair and regeneration.

This morning, RGRX provided an update on the status and timing of the four ophthalmic clinical trials for dry eye syndrome and neurotrophic keratopathy (NK) scheduled to begin in the U.S., Korea and China in 2015. The trials in Korea and China are being sponsored by RGRX’s strategic partners in their respective territories. In the U.S., the dry eye and NK clinical trials are being sponsored by ReGenTree LLC, which is a joint venture between RegeneRx and G-treeBNT. The trials will test RGN-259/GBT-201, which is a sterile, preservative-free ophthalmic eye drop.

RGRX said that its representatives, along with those from G-treeBNT, met with the U.S. Food and Drug Administration (FDA) to finalize details of the Phase IIb/III trial in patients with dry eye syndrome. Following the positive outcome of the meeting, ReGenTree is now preparing to enroll patients in the U.S. dry eye and NK clinical trials. Enrollment will begin next month, according to RegeneRx’s press release this morning.

RGRX expects to complete the Phase IIb/III dry eye trial to be completed during the first half of 2016. The Phase III NK trial is expected to be completed in the second half of 2016 or sooner.

In Korea, G-treeBNT has received permission from the Korean ministry of Food and Drug Safety (MFDS) to commence its Phase IIb/III clinical trial for dry eye syndrome. The trial in China is awaiting approval from the Chinese Food and Drug Administration (CFDA).

Shares have been uptrending nicely since the start of 2015, up about 150% in this short time, however are down slightly on the day with a few hours of trading left.

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