Indevus Initiates Multi-Dose Phase I Clinical Trial of Aminocandin for Systemic Fungal Infections
Wednesday October 6, 9:02 am ET
LEXINGTON, Mass.--(BUSINESS WIRE)--Oct. 6, 2004--Indevus Pharmaceuticals, Inc. (NASDAQ: IDEV - News) today announced the initiation of a multi-dose Phase I trial of aminocandin, under development as a treatment for systemic, invasive fungal infections.
This trial will test the safety, tolerability and pharmacokinetics of rising multiple doses of aminocandin among 32 healthy volunteers. In addition, the in vitro activity of aminocandin will be evaluated in serum samples from trial subjects challenged with certain species of the fungi candida and aspergillus. Four intravenously administered doses of the drug will be tested, and escalation to the next higher dose will be based on safety as well as systemic and local tolerance.
"This trial builds upon the results of our recently completed, initial Phase I clinical trial showing that aminocandin was well tolerated and demonstrated a prolonged duration of antifungal activity following single-dose therapy," said Glenn L. Cooper, M.D., chairman, president and chief executive officer of Indevus. "We believe that certain important differentiating features of the compound observed to date, including broad spectrum fungicidal activity and long serum half-life compared to other anti-fungal agents, may help make aminocandin a particularly attractive agent for the treatment and prophylaxis of serious fungal infections.
"We plan to move this important asset in our product pipeline forward expeditiously, and pending the successful completion of this multi-dose trial, the clinical program for aminocandin will move forward into Phase II studies next year," said Dr. Cooper.
Aminocandin is a member of the echinocandin class of anti-fungal agents, the first new class of such agents to be developed and introduced in more than 40 years. Echinocandins are designed to be fungicidal, that is, to destroy fungi, rather than simply to inhibit their growth, and to have broad-spectrum activity against the fungi that cause serious systemic infections. Indevus licensed exclusive worldwide rights to aminocandin from Aventis SA in April, 2003.
According to reports from Datamonitor, Inc., an industry market research firm, the worldwide market for anti-fungal agents is currently valued in excess of $4 billion, of which approximately $2.5 billion relates to systemic, invasive fungal infections, and is projected to grow to $6.5 billion by 2008, of which approximately one-half is predicted to represent systemic infections.
Indevus Pharmaceuticals is a biopharmaceutical company engaged in the development and commercialization of a diversified portfolio of pharmaceutical product candidates, including multiple compounds in development: SANCTURA(TM) and SANCTURA XR(TM) (once-a-day SANCTURA), pagoclone for panic and generalized anxiety disorders, IP 751 for pain and inflammatory disorders, PRO 2000 for the prevention of infection by HIV and other sexually transmitted pathogens and aminocandin for systemic fungal infections.... |
