A possible new anti-viral drug designated FV-100, which could alleviate the suffering of millions of people with herpes zoster or shingles, has entered the second stage of clinical testing in patients.

Developed and patented by scientists based at Cardiff University, a Phase II clinical trial with FV-100 has recently been initiated in America. Previous research has shown the drug to be up to 10,000 times more potent than existing treatments in early lab tests.

The drug was discovered by a team in the Welsh School of Pharmacy and a virology group at the Rega Institute in Belgium, and is being further developed in collaboration with the U.S - based biopharmaceutical company, Inhibitex Inc. If it successfully demonstrates both safety and biological activity in this and subsequent trials, the treatment has the potential to improve the lives of over 2.5 million herpes zoster patients worldwide.

Shingles is caused by the same viral infection that causes chicken pox. It is estimated that around one in five people in the U.S., Europe and Japan will be affected by the debilitating condition during their lifetime. It is generally characterised by skin lesions, blisters and rash, and acute pain, and in many cases, post-herpetic neuralgia (PHN), which is a painful and often highly distressing condition resulting from nerve damage caused by the virus. Inhibitex believes FV-100 has the potential to reduce all of these symptoms.

Cardiff University’s Professor of Medical Chemistry Chris McGuigan, who led the team which discovered the anti-viral drug said:

“We believe this drug has the potential to be the most powerful inhibitor ever discovered to treat shingles.

“Each year only 25 new medicines are approved for clinical use [worldwide or by the FDA]. Although FV-100 is early in its overall development plan, the chances of it becoming an approved medicine improves the further we successfully progress through each of the clinical stages. We are incredibly excited at the prospect of FV-100 becoming commercially available in the future, and potentially being the first drug discovered in Cardiff University to make it to the marketplace.”

In Phase I trials of FV-100, Inhibitex reported no serious adverse events in healthy volunteers and data supported the potential for once-a-day dosing in future trials. Inhibitex anticipates completing its first Phase II trial of FV-100 in the first half of 2010.

Russell H. Plumb, president and chief executive officer of Inhibitex, Inc said: “We have more than 20 U.S sites qualified to enroll patients, and plan to ultimately utilise a total of 50-60 sites in this trial. We believe this enthusiastic response from the clinical community reflects its recognition of the significant unmet medical needs of the increasing number of shingles patients.”

Source:
Professor Chris McGuigan

Cardiff University

Depomed, Inc. (NASDAQ:DEPO) announced that it has completed enrollment of the Phase 3 clinical trial of DM-1796 for the treatment of post-herpetic neuralgia.

“We are glad that we successfully arrived at another milestone that brings Depomed closer to potential milestone payments related to the development of DM-1796 and further royalties and sales milestones upon its approval. We remain excited to have Solvay Pharmaceuticals as a strong and committed partner in the neuroscience field, we share with their expectation that DM-1796 could become a significant product for the treatment of neuropathic pain,” said Carl A. Pelzel, Depomed’s president and chief executive officer. Dr. Michael Sweeney, Depomed’s vice president, Research and Development, added, ” I would like to thank all clinical investigators, patients, and Depomed employees whose dedication to DM-1796 enabled us to complete enrollment as planned. We look forward to the top-line results of the trial in the fourth quarter of this year.”

Clinical Development Status

In March 2008, Depomed initiated dosing of the first patient in this Phase 3 clinical trial for DM-1796 for PHN. The study is a randomized, double-blind, placebo-controlled study of approximately 450 PHN patients. Patients in the study are randomized into two treatment arms: placebo, or 1800mg of DM-1796 dosed once daily.

Postherpetic Neuralgia (PHN)

Postherpetic neuralgia (PHN) is a persistent neuropathic pain condition. It is caused by nerve damage after a shingles, or herpes zoster, viral infection and afflicts approximately one in five patients diagnosed with shingles (~ 150,000 individuals) in the U.S. The incidence of PHN increases in elderly patients, with 75 percent of those over 70 years old who have shingles developing PHN. The pain associated with PHN reportedly can be so severe that some patients are unable to resume normal activities for months.

Leveraging Depomed’s Gastric Retentive Technology

Gabapentin available on the market today is formulated for immediate release (IR). Upon ingestion, the entire administered dose is released into the stomach allowing for it to be rapidly absorbed into the blood. This rapid absorption leads to peak concentrations of the active ingredient, which gives rise to commonly experienced side effects including dizziness and daytime sleepiness. Patients taking immediate release formulations of gabapentin frequently need to take it three to four times a day to effectively manage their pain.

Formulated with gastric retentive technology, DM-1796 is designed for targeted, controlled release to the upper GI tract over a six to eight hour period. This extended release allows for the drug to be gradually absorbed into the blood, reducing the likelihood of peak concentrations and potentially resulting in fewer side effects than seen with immediate release formulations. Greater treatment tolerability and a more convenient dosing regimen made possible with this technology could potentially translate into greater patient compliance and ultimately better pain management.

About Depomed

Depomed, Inc. is a specialty pharmaceutical company with two product candidates in Phase 3 clinical development, two approved products on the market and other product candidates in its early stage pipeline. Product candidate DM-1796 is in Phase 3 clinical development for the treatment of neuropathic pain and has been licensed to Solvay Pharmaceuticals. Product candidate SeradaTM is in Phase 3 clinical development for menopausal hot flashes. GLUMETZA® (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and promoted by Santarus, Inc. in the United States. Proquin® XR (ciprofloxacin hydrochloride) is approved in the United States for the once-daily treatment of uncomplicated urinary tract infections. Depomed formulates its products and product candidates with its proven, proprietary Acuform® drug delivery technology, which is designed to improve existing oral medications, allowing for extended, controlled release of medications to the upper gastrointestinal tract. Benefits of Acuform-enhanced pharmaceuticals include the convenience of once-daily administration, improved treatment tolerability and enhanced compliance and efficacy. Additional information about Depomed may be found on its website, www.depomed.com.

Source
Solvay Pharmaceuticals, Inc.