NEW YORK, NY--(Marketwire - Jan 3, 2013) - 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 TiGenix, NV (Euronext Brussels: TIG), a leading cell therapy company that markets the only cell therapy approved to date and fully reimbursed in Europe, ChondroCelect for the repair of knee cartilage. The Company is also developing a series of therapeutic candidates based on its platform technology of expanded stem cells extracted from adipose tissue (eASCs). TiGenix's most advanced clinical program is Cx601 for the treatment of complex perianal fistulas in patients with Crohn's disease. Cx601 is currently being tested in the ADMIRE-CD Phase III trial, which began enrolling patients in July 2012. Data from the trial are expected in the second half of 2014.
"TiGenix's eASC therapeutic platform has produced treatments with the ability to promote a local anti-inflammatory effect, systemic immunomodulatory effects, and possessing low immunogenicity," said Andrew I. McDonald, Ph.D., Managing Director at LifeSci Advisors. "Their strong safety profile and ability to treat autoimmune and inflammatory conditions may give eASCs an important competitive advantage compared to other therapies."
In a 37-page Initiation Report by LifeSci Advisors, we explain the scientific basis and commercial prospects for TiGenix's therapeutic candidates that are based on the eASC platform. TiGenix is exploring different methods of delivery for the eASCs, each of which is applicable to a different therapy area. Cx601, currently in Phase III, is the Company's most advanced clinical program, and it involves intralesional injection of eASCs for the treatment of complex perianal fistulas related to Crohn's disease. The next most advanced program is Cx611 which is administered systemically by intravenous infusion and is designed to target rheumatoid arthritis and related autoimmune/inflammatory diseases. Cx611 has recently finished enrollment for a Phase IIa trial, and data is expected in April, 2013. In addition, the Company has already completed a Phase I trial for Cx621, which is administered via intralymphatic injection and has the potential to target a variety of autoimmune conditions.
TiGenix is already commercializing ChondroCelect, the first EMA approved and reimbursed cell therapy product in Europe. The treatment is indicated for the repair of single symptomatic cartilage defects of the femoral condyle of the knee (ICRS III or IV) in adults. TiGenix has estimated that as many as 28,000 adult patients in Europe are eligible each year for treatment with a cartilage regeneration product such as ChondroCelect. The primary commercial focus for this product is to increase reimbursement coverage in the EU. ChondroCelect has already received favorable reimbursement coverage in Belgium and the Netherlands, and use of the treatment is increasing in those countries. TiGenix is in active discussions with regulators in Spain, France, and Germany regarding national reimbursement, and the Company has said that they expect a positive coverage decision from at least one of these countries in the coming months.
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.
The research report described in this press release is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell securities. The securities discussed in LSA research reports may be unsuitable for some investors depending on their specific investment objectives, financial status, risk profile, or particular needs. Investors should consider LSA reports as only a single factor in making their investment decisions and should not rely solely on these reports in evaluating whether or not to buy or sell the securities of the subject company. LifeSci Advisors has been compensated by the company that is the subject of the report described and future research reports, investor relations services, and general consulting services. Please read each report's full disclosures and analyst background on the LSA website, www.lifesciadvisors.com, before investing. LifeSci Advisors is not a registered investment adviser or broker-dealer.
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. These forward-looking statements represent LSA's judgment as of the date of this release. LifeSci Advisors disclaims, however, any intent or obligation to update these forward-looking statements.