Isolagen, Inc.'s Cell Therapy Treatment For Wrinkles Shows Promise
The surge was attributed to preliminary positive results from two late-stage tests of the Chester County biotechnology company’s skin-and-tissue rejuvenation therapy.
Called Isolagen Therapy, the process involves harvesting and multiplying a patient’s own collagen-producing cells, or fibroblasts, into tens of millions of new cells that are returned to a patient’s skin, through injections, to repair damage. It’s part of a field called autologous cell therapy, which by definition refers to re-implanting a person’s own cells.
The company is initially testing the therapy as a treatment for “nasolaboial folds,” more commonly known as wrinkles.
Isolagen officials said its two phase-III clinical studies produced “highly statistically significant” results in terms of decreasing the appearance of wrinkles in the skin.
“We are elated and very proud,” said Nicholas L. Teti Jr., the company’s chairman during a conference call with investors.
The company is preparing complete test results, but declined to provide a specific time frame for when that data will be made public.
Isolagen’s stock, when the preliminary results were announced Aug. 5, soared to a $1.61 closing price after opening at 52 cents per share. Earlier this week the stock was trading at $1.40 per share.
Teti said the positive study results “further support the proof of principle for autologous cell therapy and opens the door for future research (of the therapy) in aesthetics, acne scars, burn scars and other clinical applications. … As the future evolves and current therapies continue to show their age, the need for novel skin rejuvenation products becomes evident.”
Declan Daly, president and CEO of Isolagen, said the company intends to file a biologics license application with the Food and Drug Administration seeking approval for its Isolagen Therapy early next year.
Daly said the company is looking to raise additional funds and is exploring everything from a partnership with a large pharmaceutical firm to PIPE (private investment in public equity) deals.
“We have several options open to us now that we have the clinical trial data,” he said. “We haven’t decided yet what one is the best option for us.”
Teti said Isolagen’s extensive testing of 421 patients in the two clinical trials will raise the standards other companies will have to meet in developing and testing competitive autologous cell therapy treatments.
Isolagen is also testing its therapy in patients with acne scars.
Last year the company suffered a setback when the FDA asked it to conduct an additional midstage clinical trial for the acne indication. The FDA had no safety issues with the treatment, but the agency wanted the company to further clarify certain protocol issues and raised questions related to the company’s acne scar evaluation assessment scale.
Prior to the results of the phase-III clinical trials, Isolagen was in the process of appealing a delisting notification it received from the American Stock Exchange in March. A hearing on the delisting is scheduled for Aug. 19.
The delisting notice was based on the company’s inadequate stockholders’ equity level. AMEX requires companies with two or more years of losses in its last three years to have a minimum net worth of $2 million. In May, the Amex rejected the company’s plan of compliance and initiated delisting proceedings.
Daly said as a development-stage biotech company with no product revenues, Isolagen has not been in compliance with the stockholder equity requirement for several years. He noted that Amex typically will not enforce that rule with companies that have a market capitalization above $50 million.
With its recent stock jump, Isolagen’s market cap figure is at about $45 million. Daly said the company plans to discuss its financing plans with Amex officials at next week’s hearing.