Avigen expands further into chronic-pain market

By Elaine Rigoli

Tampa, Fla., Sept. 11 - Avigen, Inc. said Monday that it continues to develop its product pipeline for three drugs to treat chronic pain: AV650 for spasticity and neuromuscular spasm; AV411 for neuropathic pain; and AV513 for the treatment of multiple bleeding disorders, including hemophilia.

The company announced the following strategy for the three drug candidates:

• AV650: A non-sedating drug approved in the European Union to treat muscle spasms/spasticity (Mydocalm), the company will seek to obtain a general spasticity claim and non-sedation claim, begin clinical investigation (a non-sedation trial is already planned for the third quarter of 2006; the company seeks approval for a phase 2 trial in spasticity in the fourth quarter of 2006) and file intellectual property.

"We have started a clinical investigation looking at motor response and sedation in a blinded fashion, with results expected by the end of the year," Kenneth Chahine, president and chief executive officer, told the Think Equity Partners 4th annual growth conference. Chahine cited a market of $1.6 billion worldwide.

• AV411: A novel mechanism for neuropathic pain, the company said it is starting a phase 2 trial and will file an Investigational New Drug application in the fourth quarter of 2006 or the first quarter of 2007. The study has been approved in Australia as a double-blind, placebo-controlled, dose-escalating trial. The primary endpoints are pharmacokinetic data, safety and efficacy.

"This trial will give us the human experience that we can now use to leverage a much larger U.S. phase 2 trial," said Chahine. The company will also look to expand the clinical development program into areas such as chemotherapy-induced neuropathic pain and opiate withdrawal and will aggressively file intellectual property.

• AV513: As an oral treatment for bleeding disorders such as hemophilia, the company said it will develop a clinical development plan, pursue research (i.e., optimize drug substance and explore additional applications) and aggressively file intellectual property.

"As you can imagine, giving children an intravenous administration treatment three times a week is very challenging. There is a lot of excitement over the oral option for a hemophilia drug," Chahine added.

AV650 and AV411 are approved outside of the United States, and all have good safety profiles at prescribed doses, the company said.

The company had $80 million in cash at the end of the second quarter of 2006. The projected 2006 cash-burn is $17 million to $20 million.

The Alameda, Calif.-based company, which sold its gene therapy assets last September for $12 million to Genzyme Corp., said that through a combination of internal research, acquisitions and in-licensing, its goal is to become a fully integrated commercial biopharmaceutical company committed to small molecule and biologics neurology products.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.