Guilford Pharmaceuticals Inc. on Monday said it initiated a Phase III development program for Aquavan Injection, a candidate for procedural sedation.
The decision to enter Phase III follows the firm's end-of-Phase II meeting with the FDA. Data from the 64-patient Phase II trial are expected in the second quarter, Stacey Jurchison, director, corporate communications of Baltimore-based Guilford, told BioWorld Today.
Meanwhile, Guilford expects the Phase III program to be completed in 2005. Under the best of circumstances, the firm will file a new drug application based on data from 1,200 patients (including data from Phase I and II trials) in early 2006, Jurchison said.
Guilford's stock (NASDAQ:GLFD) Monday fell 30 cents to close at $5.78.
In a conference call, Craig Smith, the firm's president and CEO, said the 900-patient Phase III program will consist of four trials and a series of smaller studies in special patient populations. The Phase III trials will be conducted in patients undergoing colonoscopy, bronchoscopy, cardiac procedures and minor surgical procedures.
Guilford anticipates seeking approval of Aquavan in mild to moderate sedation for brief diagnostic and therapeutic procedures such as colonoscopy, bronchoscopy, interventional cardiology and minor surgical and therapeutic procedures. Aquavan is a water-soluble prodrug of propofol exclusively licensed by Guilford from ProQuest Pharmaceuticals Inc., of Lawrence, Kan. Unlike propofol, which is formulated in an oil or lipid-based emulsion, Aquavan Injection is formulated in a clear aqueous solution and is converted by an enzyme in the body called alkaline phosphatase into propofol after intravenous injection. The first two Phase III trials (colonoscopy and bronchoscopy) will be randomized comparisons with midazolam. All patients will receive fentanyl citrate for analgesia.
The primary endpoint will be success of sedation as determined by a score of less than 4 using the Modified Observer's Assessment of Alertness/Sedation scale. Secondary endpoints will include time to fully alert, time to fully recovered and duration of sedation, Smith said. At the request of the FDA, Guilford also intends to conduct a series of smaller studies in special patient populations such as burn patients, patients undergoing upper endoscopy prior to liver transplant and patients having an arterovenous shunt placed for renal dialysis.
Guilford plans to maintain U.S. marketing rights in the procedural sedation indication, but likely will consider partnerships for ex-U.S. rights, Jurchison said. Also in the call Monday, company executives reported on Guilford's financial results for the quarter ended March 31.
For the first quarter, the company reported a net loss of $18.1 million, or 53 cents per common share, compared to a net loss of $11.2 million, or 37 cents per common share, for the same period in 2003. Total revenues in the first quarter were $8.9 million, compared to $3.5 million in the first quarter a year ago, substantially all of which was attributable to revenue from the sale of Gliadel Wafer for the treatment of brain cancer and Aggrastat Injection for acute coronary syndrome.
Net product sales of Gliadel Wafer increased in the first quarter to $5.5 million, compared to $3.4 million. The company attributed the increase in sales to the impact of the expansion of Guilford's sales force and increased demand for the product following approval for an expanded indication in February 2003.
Net product sales of Aggrastat were $3.2 million for the first quarter. In the fourth quarter, Guilford acquired U.S. sales and marketing rights to Aggrastat from Merck & Co. Inc., of Whitehouse Station, N.J., in a deal valued at $84 million. (See BioWorld Today, Oct. 30, 2003.)
As of March 31, Guilford had $81 million in unrestricted and restricted cash, cash equivalents and investments, compared to $101.9 million on Dec. 31. The firm raised in December $27.4 million through a private placement of 4.8 million shares of its common stock at $5.67 apiece for the advancement of the Aggrastat and Aquavan programs. (See BioWorld Today Dec. 11, 2003.)