(Reuters) - BioTime Inc said on Wednesday its Renevia system succeeded in meeting the main goal of a pivotal European trial for facial wasting associated with treatment for HIV, putting it on track to file for European approval this year.
The 47 patients in the study were suffering from HIV-associated facial lipoatrophy, an abnormal loss of fat from the face that gives people a gaunt, sunken-face appearance. It can be caused by the raft of antiviral medicines used by HIV patients to keep the virus in check.
Renevia is a hydrogel polymer that is mixed with precursor cells derived from fat elsewhere in the body, providing the cellular structure that allows them to graft and survive in a new location in the face.
Treated patients had about 5 cc of Renevia injected into each side of the face and were measured for facial volume after six months.
At six months, those who received Renevia on average had 5.1 cc of the new hemifacial volume, representing 100 percent retention of the transplanted material, compared with no new facial volume in untreated patients. The results were deemed to be statistically significant.
“The retention of the transfer volume after six months in patients is quite impressive and we look forward to evaluating the 12-month data,” Dr Ramon Llull, the study’s primary investigator, said in a statement.
There were no serious side effects associated with Renevia treatment reported in the trial, BioTime said.
About 350,000 HIV patients in Europe suffer from significant facial lipoatrophy, the company said. With this data in hand, BioTime plans to discuss requirements for U.S. trials with the Food and Drug Administration.
Once the company secures approvals for the HIV-related condition, it plans to go after the far larger and lucrative facial aesthetics market, Co-Chief Executive Adi Mohanty said.
In that market, it would be aimed at and used by plastic surgeons, a cash business that does not rely on reimbursements from insurers, much like Allergan Plc’s hugely successful Botox.
Dermal fillers and other widely used fat transplant methods tend to lose volume far more quickly that what has been demonstrated by Renevia, Mohanty explained.
And if Renevia works using cells compromised by the effects of HIV medications, the company believes even better results are possible with healthy subjects.
“If those cells are still attaching and grafting and surviving, then healthier cells should have no trouble,” Mohanty said.
Reporting by Bill Berkrot in New York; Editing by Matthew Lewis