RXI-109 has the Potential to Become the First FDA Approved Product for Scar Prevention and Reduction
Available for Download at www.lifesciadvisors.com/clients/rxi/
NEW YORK, NY – November 28, 2012 – LifeSci Advisors, LLC, a leading provider of investment research and investor relations services in the life sciences sector, today announced that it has initiated coverage of RXi Pharmaceuticals (OTC: RXII), a biotech company focused on the discovery and development of novel RNAi therapeutics to treat diseases that can be addressed with local delivery. RXi has developed a revolutionary rxRNA technology platform that includes several different types of RNAis that are designed to circumvent delivery and tolerance issues associated with the development of traditional RNAi compounds. With this in mind, the Company has developed RXI-109, its lead RNAi drug candidate targeting CTGF for scar prevention and reduction, an estimated $2.5-5B market opportunity.
“RXI-109 has the potential to become the first FDA approved product for scar prevention and reduction, a space that we believe has a large unmet need due to the questionable efficacy of currently available products ,” said Andrew I. McDonald, Ph.D., Managing Director at LifeSci Advisors. “Excaliard is a private company that developed EXC-001, an antisense oligo also targeting CTGF. In three randomized Phase 2a studies, EXC-001 demonstrated statistically significant decreases in scarring as observed by photographic comparisons and measured by a physician assessment scale. Following these positive results, Excaliard was acquired by Pfizer for an amount that we estimate to be greater than $200M. We believe that RXI-109 also has the potential to demonstrate similar efficacy and therefore, attract similar interest from big pharmaceutical companies.”
In a 40-page Initiation Report by LifeSci Advisors, the scientific rationale, clinical history, regulatory status, and market opportunities for RXI-109 are clearly outlined. RXI-109 is one of the Company’s sd-rxRNA compounds, which are RNAi-based oligos that are soluble in saline and can penetrate cells without damaging the cell membrane. In an in vivo 8-day rat skin model, 300 µg and 600 µg doses of RXI-109 induced 51% (p=0.015) and 67% (p=0.0001) reductions in CTGF expression, respectively. Most recently, early data from the Company’s first Phase 1 clinical study with RXI-109 in 15 healthy volunteers became available. In this “single-dose” study, the maximum intradermal dose was on average 0.3 mg/kg, which is approximately 30 times lower than doses successfully administered to primates. Furthermore, relative systemic exposure of RXI-109 was low at only 5%. The Company’s second Phase 1 “multi-dose” study is slated to begin before year-end 2012. We expect to see additional data from both of these studies over the next 6 months with a possible Phase 2 RXI-109 trial initiation by mid-year 2013.
Dr. McDonald’s full Initiation Report is available to download at no cost at the LifeSci Advisors website, www.lifesciadvisors.com. In addition to this Initiation Report, LifeSci Advisors will also provide ongoing coverage and event-based research updates on the Company as developments occur.
The LifeSci Advisors research team is led by Dr. Andrew I. McDonald, an industry veteran with more than 15 years of healthcare industry experience. Prior to co-founding LSA, Dr. McDonald was the Senior Biotechnology Analyst at Great Point Partners, a leading health care investment firm with over $500 million under management. Before Great Point, he was Co-Head of Healthcare Research and Lead Biotechnology Analyst at ThinkEquity Partners, a boutique investment banking firm focused on growth companies. Dr. McDonald holds a Ph.D. in organic chemistry from the University of California, Irvine, and, earlier in his career, worked as a medicinal chemist at both Pfizer and Cytokinetics.
About LifeSci Advisors:
LifeSci Advisors (LSA) is a leading research firm and communications consultancy dedicated to the life sciences industry. The firm provides strategic counsel, customized marketing communications, comprehensive research reports and investor relations services to companies that specialize in the discovery, development and commercialization of drugs, drug delivery systems, medical devices and diagnostics. To learn more about LSA, visit the company’s website, www.lifesciadvisors.com.
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