PRN: Clinical Trial Advancements With Positive Data for Phase 1 and 2 Results Fueling Steady Growth in Biomedical Industry

04/apr/2017 14:34:57 PR Newswire Turismo Contatta l'autore

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Clinical Trial Advancements With Positive Data for Phase 1 and 2 Results Fueling Steady Growth in Biomedical Industry


PALM BEACH, Florida, April 4, 2017 /PRNewswire/ -- News Commentary 

The biotech sector, including regenerative medicines continues to grow at a healthy and steady rate as a result of clinical trial and technological advancements in biomedical therapies/treatments as well as tissue and organ regeneration. The regenerative segment today alone continues to advance with the emergence of enhanced research and development. Industry news and market performance of note this week include: RepliCel Life Sciences Inc. (OTC: REPCF) (TSXV: RP.V), Wright Medical Group N.V. (NASDAQ: WMGI), NovoCure Limited (NASDAQ: NVCR), PDL BioPharma, Inc. (NASDAQ: PDLI), PolarityTE, Inc. (NASDAQ: COOL).

RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) is pleased to report statistically and clinically significant positive data from the interim analysis of its phase I study evaluating RCS-01 for the treatment of aging and sun-damaged skin. The primary objective of this trial was to establish a complete safety profile for intradermal injections of RCS-01 (RepliCel's type 1 collagen-expressing, hair follicle-derived fibroblasts 'NBDS cells') at six months post-injection. Participants in the Germany-based study did not report any serious adverse events at the interim point of the trial. Researchers also gathered compelling positive proof-of-concept data indicating the product's potential for skin rejuvenation. Read this and more news for RepliCel Life Sciences at:

The study was neither powered for, nor was expected to show statistically significant results of efficacy. However, the nearly two-fold increase in gene expression of collagen-related biomarkers in the skin, after a single injection of RCS-01, was so profound with a single RCS-01 injection, that the results are considered statistically significant. The study observed the impact of the injection on ten different biomarkers that, in peer-reviewed medical literature, are highly correlated with skin aging and chronically sun-damaged skin. Notably, gene expression markers, such as tissue inhibitor of metalloproteinases (TIMP), showed significant changes expected to correlate with increased collagen fibers. Increased collagen production, and reduced collagen degradation, is associated with fewer wrinkles and the repair of sun-damaged skin.

"This type of positive effect on TIMP gene expression, which is related to protection against collagen degeneration, is rarely observed. In my experience, after decades of performing these tests, this is an exceptional finding, particularly for a safety trial with a small sample size," stated Prof. Dr. med Jean Krutmann, Scientific Manager of the IUF Leibniz Research Institute for Environmental Medicine where the study was conducted. "The promising results demonstrate the potential of RCS-01 to promote skin rejuvenation. An increase in collagen markers of this nature would be expected to translate into clinically measurable and aesthetically visible effects."

In other industry happenings and market performance stand outs: 

Wright Medical Group N.V. (NASDAQ: WMGI) closed up on Monday at $31.15 trading over 1.9 Million shares by the market close. Wright Medical Group designs, manufactures, markets, and sells extremities and biologics products in the United States, Europe, the Middle East, Africa, and internationally. The company offers joint implants and bone fixation devices for the shoulder, elbow, wrist, hand, foot, and ankle; and biologics products that are used for supporting the treatment of damaged or diseased bones, tendons, and soft tissues, as well as to stimulate bone growth.

NovoCure Limited (NASDAQ: NVCR) close up over 37% on Monday at $11.10 trading over 23.3 Million shares by the market close. Novocure announced final results from its phase 3 pivotal EF-14 trial adding Optune to standard temozolomide chemotherapy for the treatment of newly diagnosed glioblastoma (GBM). Landmark analyses show a consistent and maintained improvement in overall survival at two, three, four and five years. The final results include data from all 695 patients included in the EF-14 trial with a median follow-up of 40 months.

PDL BioPharma, Inc. (NASDAQ: PDLI) closed up slightly on Monday at $2.30 trading over 2.7 Million shares by the market close. PDL BioPharma acquires and manages companies, products, royalty agreements, and debt facilities in the biotech, pharmaceutical, and medical device industries in the United States, Europe, and internationally. 

PolarityTE, Inc. (NASDAQ: COOL) closed up over 21% on Monday trading over 1.2 Million shares by the market close. PolarityTE™, Inc. is the owner of a novel regenerative medicine and tissue engineering platform developed and patented by Denver Lough MD, PhD. This radical and proprietary technology employs a patients' own cells for the healing of full-thickness functionally-polarized tissues. If clinically successful, the PolarityTE™ platform will be able to provide medical professionals with a truly new paradigm in wound healing and reconstructive surgery by utilizing a patient's own tissue substrates for the regeneration of skin, bone, muscle, cartilage, fat, blood vessels and nerves.

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