It’s been more than a year and a half since San Diego’s Celladon revealed that its gene therapy treatment might help people suffering from heart failure, a period of quietude that left some folks wondering if the life sciences startup still had a heartbeat.
But Celladon sprang to life today with some major news. The company says it has raised $43 million from investors to advance the clinical development of Mydicar, its experimental treatment for patients with advanced heart failure. In addition, Celladon says the Food and Drug Administration granted “fast track status” to Mydicar in December.
A new investor, Pfizer Venture Investments, led the latest founding round, which also included new investors Lundbeckfond Ventures, Novartis Venture Funds, H&Q Healthcare/Life Sciences Investors, and GBS Venture Partners. All previous investors—Enterprise Partners Venture Capital, Johnson & Johnson Development Corp., and Venrock Associates—also participated in the round.
The company was founded in 2000, and a recent article in Dow Jones VentureWire said Celladon had raised more than $56.3 million by 2009 from investors that included Enterprise Partners Venture Capital, Domain Associates, Johnson & Johnson Development Corp., Kleiner Perkins Caufield & Byers, and Venrock.
Celladon’s breakout news comes shortly after scientists at the Cedars-Sinai Heart Institute in Los Angeles reported that they used cardiac stem cells to regenerate heart muscle in patients who had suffered heart attacks. Heart tissue is damaged during heart attacks, but cardiac scar tissue among patients who received the stem cell infusions shrank in half—from 24 percent to 12 percent of the heart. The study was small, however, with just 17 of 25 patients in the study receiving stem cells cultured from their own healthy heart tissue.
Celladon’s test also was small, enrolling 39 patients with advanced heart failure who were randomly assigned to get a single-shot infusion of Mydicar. The treatment delivers a gene to help people with heart failure pump blood more efficiently.
In its statement today, Celladon says its mid-stage trial met its primary safety and efficacy goals for a high dose of Mydicar versus a placebo. After 12 months, the patients who were treated with the highest dose also showed an 88 percent risk reduction of major cardiovascular events, such as death, need for a heart transplant or ventricular assist device, and episodes of worsening heart failure.
“The positive results of the phase 2 Cupid Trial demonstrated the potential of Mydicar to become an important treatment for patients with chronic, advanced heart failure” Celladon CEO Krisztina Zsebo says in the statement from the company.
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