Stox Dude : Info ueber Avigen/Bayer..............
SAN FRANCISCO -(Dow Jones)- Avigen Inc. (AVGN) said its Coagulin-B therapy for hemophilia B, administered via injection, has been shown to be safe and well-tolerated in ongoing clinical trials.
Coagulin-B carries the gene for Factor IX, the deficient protein that causes hemophilia B.
In a press release, Avigen said six out of seven patients in the Coagulin-B trial showed evidence that the gene was expressed in the muscle cells, and several patients demonstrated a reduction in the amount of Factor IX needed to control bleeding episodes.
The biotechnology company said it submitted an investigational new drug application to the Food and Drug Administration for a form of Coagulin-B that would be delivered directly to the liver.
Avigen plans to initiate a human clinical trial to evaluate liver delivery of the drug in the next few months, based on preclinical data from tests on dogs.
In November Avigen entered an agreement, valued at up to $60 million, granting Bayer Corp. (G.BAY) worldwide marketing and distribution rights for Coagulin-B. Under those terms Bayer purchased $15 million in Avigen stock, about a 2.5% stake.