Medgenics (LON:MEDG NYSE:MDGN) said it has received Orphan Drug Designation (ODD) from US regulator Food and Drug Administration for the INFRADURE Biopump to treat Hepatitis D.
The statement was released shortly before the market close in London, and the group ended the UK session up nearly 8 percent at 442.50 pence.
INFRADURE is the version of Medgenics' Biopump technology platform which produces interferon alpha, commonly used to treat hepatitis.
The step taken by the FDA marks the first ODD granted for treatment of a clinical indication using the Biopump.
ODD carries multiple benefits, including the availability of grant money, certain tax credits and seven years of market exclusivity, as well as the possibility of an accelerated regulatory process.
"The FDA's timely ODD approval for INFRADURE to treat hepatitis D is a key milestone in our broader hepatitis program as data gathered through clinical trials for INFRADURE in hepatitis D may serve as relevant support for other clinical uses of INFRADURE including hepatitis C and hepatitis B," said Medgenics chief executive Andrew Pearlman.
"Following on the FDA's recent clearance to proceed with our Phase IIb study of the EPODURE Biopump technology to treat anaemia, and the positive comments of the National Institutes of Health Recombinant DNA Advisory Committee, we see this Orphan Drug Designation from the FDA as another important step in the regulatory pathway for our Biopump platform.
“We anticipate that hepatitis D clinical studies will use INFRADURE Biopumps that are fundamentally identical to those which will be used for the treatment of hepatitis C in our two Phase I/II studies in Israel which are now awaiting final approval from the Israeli Ministry of Health," added Pearlman.
The group had announced only yesterday that it had raised US$8.4 million net through a private placing to fund further clinical trials of its Biopump range.
The Biopump removes the need for hundreds of injections used in conventional therapies for the abovementioned conditions.
In essence, a tiny sliver of the patient's tissue is taken and modified to carry the gene to enable it to continuously produce the required protein to treat the condition. It is then re-injected into the body using the firm’s proprietary device.