GERMANTOWN, Md., May 2, 2013 /PRNewswire/ -- RNL BIO, a stem cell biotechnology company dedicated to the commercialization of autologous cell therapy products for a variety of degenerative, ischemic and other indications, has announced that it has filed an Investigational New Drug application (IND) with the Food and Drug Administration (FDA) to begin clinical trials with its adipose-derived stem cell product, termed RNL-JointStem, for the treatment of osteoarthritis (OA). Assuming approval of the IND by the Center for Biologics Evaluation and Research (CBER) at the FDA, RNL BIO plans to initiate its double-blinded, randomized, positive-control Phase II clinical trial during the third quarter of 2013 in Sugarland, Texas. Dr. Jason Dragoo of Stanford University and Dr. David Alan Fisher of Indiana University acted as reviewers and completed revision of the protocol now under evaluation by the FDA. Phase I and Phase II clinical trials of RNL-JointStem have already been completed under the authority of the Korean Food and Drug Administration (KFDA).
"We are excited about filing an IND for RNL-JointStem because it brings us closer to a clinical trial with RNL-JointStem in the United States," said Jeong-Chan Ra , CEO and Chairman of RNL BIO. "Our goal for this trial is to achieve global demonstration that RNL-JointStem is efficacious. If our trial is successful it can lead to a paradigm shift in the treatment of osteoarthritis, using stem cell products derived from a patient's own fat tissue." Among the key advantages demonstrated in previous trials of RNL-JointStem is that it is administered in a single injection, unlike the many invasive treatments currently used in the treatment of OA. "Treatments of this painful chronic condition should relieve pain, not add to it," said Dr. Ra. "We hope to confirm the efficacy of RNL-JointStem for cartilage regeneration, pain reduction and joint function improvement for OA patients, and that it will see market approval in due course."
The clinical trial will compare RNL-JointStem to existing modalities utilizing hyaluronic acid (HA). The patient population for this initial clinical trial will include patients diagnosed with osteoarthritis and whose clinicians judge that they meet candidacy requirements. The intended market for RNL-JointStem is patients under 60 years of age for whom there is no efficacious therapy at present.
Degenerative arthritis is the most common type of arthritis. It is estimated that 26.9 million Americans 25 years old or older have clinical degenerative arthritis of some joints, with a higher percentage of affliction in the older population. Its clinical manifestations include joint pain and impairment to movement, and surrounding tissues are often affected with local inflammation. The etiology of degenerative arthritis is not completely understood; however, injury, age, and genetics have been considered among the risk factors.
Degenerative arthritis is a progressively debilitating disease that affects mostly cartilage, with associated changes in bone. Cartilage has limited intrinsic healing and regenerative capacities.
Through this trial
Due to the increasing incidence of degenerative arthritis and the aging population coupled with inefficient therapeutic choices, novel cartilage repair strategies are in need. The market for a therapeutically efficacious product for this indication is estimated to be very large.
About an IND
An Investigational New Drug (IND) is a procedure for the authorization to perform a clinical trial in the United States. An IND is required whenever the performance of a clinical trial in the United States is intended. The IND includes information related to the quality, manufacture and control of the Investigational Medicinal Product, data from pre-clinical studies and clinical intent-to-use. An overall risk-benefit assessment, critical analyses of the pre-clinical data in relation to the potential risks and benefits of the proposed study are required to be part of the IND.
About Phase II Clinical Trials
Studies of clinical interventions using biologics, including autologous human fat-derived stem cells, are rigorously controlled by the FDA's Center for Biologics Evaluation and Research (CBER). A phased series of clinical trials is required by the FDA after an IND is judged to be acceptable to CBER and a local institutional review board (IRB). The emphasis in Phase I is on safety, and emphasis in Phase II is on effectiveness. Phase II clinical trial is designed to focus more explicitly on study efficacy (how well the biologic works at the prescribed dose).
About RNL BIO
RNL BIO is a South Korean biotechnology company focused on the research and development of adult derived stem cell technologies. RNL has completed one phase I trial for spinal cord injury, and one Phase II clinical trial for Osteoarthritis, under the KFDA in South Korea and is near to the completion of a clinical trial for Buerger's Disease trial.
For more information visit http://www.rnl.co.kr/eng/main.asp, which is not part of this press release.
|SOURCE RNL BIO|
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