Enrollment Complete for CUPID 2 Phase IIb Trial with Results Expected in April 2015
Report Available for Download at http://www.lifesciadvisors.com/clients/celladon
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 Celladon Corporation (NASDAQ: CLDN), a clinical-stage company evaluating gene therapy and small molecule approaches to treat heart failure, a condition where the pumping of the heart can no longer keep up with systemic demand. Celladon's lead development candidate, MYDICAR, is an adeno-associated virus-mediated gene therapy that delivers a copy of the SERCA2a gene. The Company is currently testing MYDICAR in a randomized, placebo-controlled Phase IIb study that enrolled 250 heart failure patients. Data from the trial is expected in April 2015 and has the potential to support a marketing application in Europe. The FDA has granted Breakthrough Therapy Designation to MYDICAR, which could significantly accelerate the time to a potential U.S. approval decision.
"No currently available therapies for heart failure are able to stop or significantly modify the progression of heart failure. Celladon has produced a novel gene therapy, based on the cellular physiology of cardiomyocytes, that has the potential to alter the course of the disease," said Andrew I. McDonald, Ph.D., Founding Partner at LifeSci Advisors. "If MYDICAR is shown to be a safe and effective disease-modifying treatment for heart failure, the improvement in patients' health and associated pharmacoeconomic benefits should drive significant value for Celladon."
The expression of the SERCA2a, or sarco/endoplasmic reticulum Ca2+-ATPase 2a, gene, is reduced in advanced heart failure, which adversely affects the contractility of the heart. Preclinical studies have demonstrated improvement in cardiac function after reintroduction of an additional copy of the gene. The Company has released positive results from the CUPID 1 Phase I/IIa clinical trial, finding a favorable safety profile, long-term expression of the SERCA2a transgene and, most importantly, a reduction in heart failure-related clinical events. Over the course of a 3 year follow-up, there was an 82% reduction in the rate of clinical events.
In a 41 page Initiation Report by LifeSci Advisors, we explain the market potential for Celladon's MYDICAR therapy and potential advantages over other treatments for heart failure. We provide detailed background on heart failure and the clinical data produced to date for MYDICAR. The report also discusses a range of additional potential indications for MYDICAR as well as additional early-stage development efforts at the Company. Given the field of gene therapy is still in its early stages, Celladon is well-positioned to be a leader in this space.
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.
Phone: (646) 597-6979
Celladon Corporation Contact:
Vice President, Corporate Development and Investor Relations
Phone: (858) 432-7215
SOURCE: LifeSci Advisors