Baby boys could be the source of a promising new treatment for some skin ulcers, a common problem in the elderly that is being developed by a Fort Worth company.
The new "spray-on skin" treatment developed by Healthpoint Biotherapeutics has been shown to stimulate new skin growth and healing of open leg wounds that occur due to poor blood circulation, according to results of a study published online Friday in the latest edition of Britain's prestigious medical journal, T he Lancet.
The treatment consists of a spray containing skin cells derived from carefully selected foreskins of newly circumcised baby boys.
The tissue is donated by families of selected infants that meet rigorous qualifications and testing, Healthpoint said. The two types of cell that make up human skin are removed from the foreskins and then cultivated in large quantities.
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"The treatment we tested in this study has the potential to vastly improve recovery times and overall recovery from leg ulcers, without the need for a skin graft," said Dr. Herbert Slade of Healthpoint, one of the study authors.
The study chronicled in The Lancet is just one-phase in the long, rigorous testing process designed to secure approval from the U.S. Food and Drug Administration and its counterparts in other countries, with preparations already under way for new trials.
"We're very pleased with where the program stands right now," said Rob Bancroft, executive vice president of Healthpoint. The company acquired the technology from a European firm in 2004 and began initial preparations for the latest trial in 2008.
"Now the program is moving very quickly," Bancroft said. "It's got high priority and we're investing heavily in it."
The study was conducted by treating patients in the U.S. and Canada with slow-to-heal wounds caused by poor blood circulation resulting from disease or injury. The best current treatment for such wounds is compression bandages, designed to improve blood flow and promote healing, but many patients respond poorly or slowly.
In the trial, patients treated with the spray developed by Healthpoint in combination with compression showed much higher rates of skin re-growth than were seen with compression alone.
By the end of the 12-week treatment periods, 70 percent of those who received the cell treatments every two weeks had wound healing, compared with just 46 percent of participants in a control group that did not receive them. Different treatment frequencies showed improvement in healing, but not at statistically significant rates. There was no difference in adverse effects.
"This is a well-done and certainly positive study looking to possibly offer a quick and readily available additional tool for the treatment of chronic non-healing venous stasis ulcers," said Dr. Maja Zaric, an interventional cardiologist at Lenox Hill Hospital in New York, who specializes in such problems.
The potential market is growing for new treatments of this type due to the expanding population of elderly in the U.S. and the preponderance of the problem in older patients. The study in The Lancet focused on only one type of wound, but company officials say their treatment could have other uses.
"We have every reason to believe it would work in other wound types," said Bancroft.
Healthpoint announced plans in June for a $60 million expansion of its West Vickery Boulevard research and manufacturing facility, the first phase of which will be completed later this year.
To achieve regulatory approvals and bring the new treatment to market by 2017 could well require a total investment of $200 million, Bancroft said.
Healthpoint is a subsidiary of DFB Pharmaceuticals, which is also based in Fort Worth.
In April 2011 the U.S. Justice Department filed a false claims lawsuit against the company, asserting that Medicare and Medicaid paid $90 million in bills for what the government says was an unapproved and ineffective drug for treating skin wounds.
Bancroft said the litigation has not been resolved.
Bob Cox, 817-390-7723