Staff Writer

Anesiva Inc. began a Phase III trial to evaluate the ability of Zingo to provide pain relief to those undergoing peripheral venous access procedures, such as intravenous line placements and blood draws.

Data from the 700-patient, placebo-controlled study in adults are expected to be available later this year and, if positive, to be sufficient to support a new drug application filing. The South San Francisco-based company in November filed an NDA for a pediatric indication, based on two Phase III trials in children ages 3 to 18.

Anesiva CEO John McLaughlin said among the advantages of Zingo is its rapid onset of action, providing analgesia as quickly as one minute. He said potential competitor products such as creams and patches typically can take 20 minutes, or even up to 60 minutes.

Zingo is a needle-free system that delivers lidocaine powder into the skin via compressed gas. The product is contained in a one-time, disposable device. The placebo group in the study will get only a puff of air from the device, without drug. The primary endpoint is relief on a pain scale, with other endpoints including physicians' perceptions and the ability to get the needle in quickly.

The quick-acting mechanism of the Zingo could make it especially suitable for use in emergency rooms, the company said. McLaughlin said discussions with health care workers in the area produced a consensus that they wanted something that worked fast. The name Zingo, even, was chosen to connote speed, he said.

The Phase III pediatric trials in more than 1,110 patients demonstrated a statistically significant reduction in pain compared to placebo when administered just one to three minutes prior to blood draws and IV line placements. A decision from the FDA on the NDA filing in pediatric patients is expected by Sept. 22.

Zingo, previously called 3268, originally was developed by AlgoRx Pharmaceuticals Inc., a Secaucus, N.J., company that merged with South San Francisco-based Corgentech Inc. in late 2005. The combined company later was renamed Anesiva. AlgoRx had been unsuccessful in its attempt at an initial public offering, and Corgentech was coming off Phase III failures of its lead E2F Decoy (edifoligide) product in lowering the rate of vein graft failure in peripheral artery bypass patients. (See BioWorld Today, Sept. 27, 2005.)

Both companies, however, had cash, and the focus turned to moving forward with the products from AlgoRx, which got about 62 percent of the combined company following the merger.

McLaughlin said Anesiva has begun partnering discussions on Zingo. Its plan is to have 35 to 40 sales representatives calling on about 1,100 hospitals in the U.S., with a co-promotion partner reaching another 1,100 or so, he said. Partnering discussions also are under way concerning rights outside the U.S.

The technology behind delivery of Zingo is similar to that used by Oxford, UK-based PowderMed Ltd. for delivery of vaccines. PowderMed uses pressurized helium to deliver microscopic gold particles coated in DNA directly to antigen-presenting cells in the epidermis. New York-based Pfizer Inc. made its entry into the vaccines field late last year through its acquisition of PowderMed. Terms were not disclosed.

Zingo delivers microcrystals of lidocaine into the epidermis.

The other significant product in the Anesiva pipeline is 4975, for which multiple Phase II trials are close to getting under way, while others have been completed.

The 4975 product is an agonist of transient receptor potential vanilloid 1, or TRPV1 (often called simply vanilloid receptor 1, or VR1). The long-acting, nonopioid agent based on capsaicin acts as a C-neuron anesthetic to relieve pain.

In January, Anesiva disclosed its strategy for upcoming Phase II and III trials of 4975. They include three 50-patient Phase II studies in the postsurgical setting, all expected to begin in the first half of this year: reducing pain associated with knee replacement surgeries, reducing pain associated with hip replacement surgeries and reducing pain associated with arthroscopic shoulder surgeries.

A 200-patient Phase II trial of 4975 for reducing pain associated with osteoarthritis of the knee also is expected to begin in first half of this year. Finally, Anesiva plans to begin a 450-patient Phase III of 4975 in knee replacement surgeries in the second half of the year.

McLaughlin said Anesiva had put off partnering discussions on 4975 until it worked out trial plans with the FDA, a process completed in January. Now those discussions have begun, he said.

Anesiva reported having about $85 million in cash as of Dec. 31. The company has not elaborated on earlier guidance, when it said its cash was sufficient to get it into 2008. It had a net loss of $55.6 million in 2006, and ended the year with 27.3 million shares outstanding.

Anesiva's stock (NASDAQ:ANSV) fell 16 cents Wednesday to close at $7.20.