By Randall Osborne
West Coast Editor
Enlarged by a Series B financing of $15 million, InfiMed Therapeutics Inc. said it will use the funds to push its sustained-release human growth hormone (HGH) more quickly toward approval - and beat others with similar products in the works.
"We're going into clinical safety studies in the first half of this year, and in the second half of the year we're going to go into Phase II/III [trials]," said Stephen Rowe, president and CEO.
"The key issue here is time," he added, noting that firms such as Sandy, Utah-based MacroMed Inc. are developing sustained HGH as an orphan drug for deficient children.
"We need to recruit at least 50 patients, children who have not been treated with it before, and we need to go out to about 25 centers," Rowe said.
"It's a race," Rowe told BioWorld Today. "We approach the world as if there are a number of competitors. Only the paranoid survive." A better-known threat is Nutropin Depot (somatropin), co-developed by Genentech Inc., of South San Francisco, and Alkermes Inc., of Cambridge, Mass.
Privately held InfiMed's drug, Infitropin CR, uses what the Cambridge, Mass.-based firm calls Improved Formulation Entity technology for delivery of proteins and peptides, trapping them in a hydrogel that degrades at a controlled rate over weeks or months after intramuscular or subcutaneous injection.
Infitropin CR has shown preclinical promise in vivo and in vitro. A sustained-release formulation of the red blood cell booster erythropoietin (EPO) has been tested preclinically, too, with good results.
Advantages of the InfiMed system include a minimal burst of drug when injected, making it safer and less wasteful, and the ability to load large amounts of the drug into microparticles, which allows smaller needles and smaller injection volumes.
Another potential extended-release application is pulmonary insulin, Rowe said, especially for young patients.
"Physicians tell us children don't prefer daily pulmonary administration of any drug," he said, noting that Inhale Therapeutic Systems Inc., of San Carlos, Calif., is the main competitor there. Children's dislike of daily HGH shots is a reason why Infitropin CR looks promising, Rowe said.
InfiMed believes its sustained-release technology will enliven the interest in large-molecule protein drugs that are not effective when taken orally.
"We're working on all these different things, and we're hopeful we can get something else in the clinic late this year, on our own or through a partner," Rowe said.
The lead investor in the financing is EGS Healthcare Capital Partners, of New York. Others include Prism Ventures, of Westwood, Mass., and Collinson, Howe & Lennox, of Stanford, Conn.