Editor’s note: BioWatch is a regular feature on Fridays.
RESEARCH TRIANGLE … Panacos Pharmaceuticals, a Maryland based company backed by A.M. Pappas and other venture funds, has agreed to merge with V.I. Technologies Inc. (Nasdaq:VITX) in a stock trade.
Vitex will issue 25 million shares of its common stock in exchange for all of Panacos shares. The deal is worth more than $25 million. VITX shares closed at $1.15 on Thursday.
Vitex will issue up to 20 million additional shares to Panacos shareholders if the company’s lead drug, PA-457, a “new class” of anti-viral drug about to enter clinical trials against H.I.V., meets near-term milestones. That could make the total value of the deal nearly $52 million based on Thursday’s Vitex closing price.
The new class of anti-viral drugs, called maturation inhibitors, was developed in collaboration with K. H. Lee at UNC-Chapel Hill.
Vitex is also headquartered in Maryland.
The new compounds interfere with a late stage of viral development key to its replication. PA-457 is specifically designed to attack AIDs-causing HIV. Attacking HIV at a different stage than any previous drugs means HIV has no resistance to them. Resistance to current drugs is a serious problem in treating AIDs patients.
Even Trimeris’ Fuzeon — one of a new class of anti-viral compounds, which attacks the much earlier stage of the viral lifecycle when it sticks its grappling hooks in healthy cells to fuse with them — develops resistance over time.
Phase I underway
Panacos successfully completed the first human clinical trial of PA-457 in March and has advanced the compound to a Phase I study of its safety and bioavailability over ten days.
Panacos has successfully raised over $26 million in two rounds of private equity funding since its inception in 2000. Panacos investors, in addition to Pappas, include Ampersand Ventures, Mitsui & Co. Venture Partners, Inc., Novo A/S, Lakeview Capital Management, William Harris Investors, New England Partners, and the Maryland Department of Business and Economic Development.
“Smart Pen” gets validation
Health Decisions, a 15-year-old company based in Chapel Hill, has been out on the forefront of electronic data capture (EDC) in the contract research organization industry since its inception, says Rob King, chief operating officer.
The company says that after months of “rigorous validation,” its digital Smart Pen is now fully compliant with FDA record keeping rules (technically, 21CFR Part 11 compliant).
The Smart Pen addresses one problem facing wider use of EDC in conducting clinical trials. “Doctors and hospitals are conservative,” says King. He notes that they dislike anything that upsets their routine activity flow.
The Smart Pen captures up to 40 pages of text and images as data is actually recorded by the doctor or researchers. Then, when placed in its cradle, it sends the digitized information over the Internet.
The company, which uses handwriting recognition software from RTP-based Mi-Co, says the information will available to managers within minutes or a day or hours. Now, King points out, the process of submitting the data and responding to queries can take months.
The pen eliminates the need for double data entry — once when recorded by hand and then again keyed into a computer. It also presents no learning curve problems.
King says that while the company thinks the Smart Pen is a competitive advantage, it’s just the latest tool. It continues to use very rapid optical scanners in other clinical trials to provide rapid data turnarounds.
“If something better comes along, we would use that too,” King says.
Health Decisions employs 55 people in 15,000 square foot Chapel Hill offices and 25 in the United Kingdom. It has been growing and hiring clinical staff, research associates, project managers, and IT people, a company spokesperson said.
Biotech Channel launch nears
You can look for the Biotech Channel (www.biotechchannel.com) next Friday, says creator Randy Gregg.
Gregg, who started RTP/TV a few years ago, says the site will launch with some coverage of Biotech 2004. It will include “radio” interviews as well as streaming video stories.
Gregg also reminded us that the Triangle Tech Journal’s BioPharma focused networking event is June 23. It will be held in the Dilweg Properties building near iLoft in the Triangle.
Health Decisions: www.healthdec.com