Indevus Initiates Phase I Clinical Trial of Aminocandin for Systemic Fungal Infections
LEXINGTON, Mass. – Indevus Pharmaceuticals, Inc. (NASDAQ: IDEV) today announced the initiation of a Phase I clinical trial with Zminocandin, a member of a new class of anti-fungal compounds under development for the treatment of a broad spectrum of systemic, invasive infections. This trial will test the safety and tolerability of escalating single doses of aminocandin administered intravenously in healthy volunteers. Results of the trial are expected in the second half of 2004.
“This trial will build upon an extensive pre-clinical dossier on aminocandin compiled by Aventis SA, from whom Indevus licensed exclusive worldwide rights to this compound in 2003,” said Glenn L. Cooper, M.D., chairman, president and chief executive officer of Indevus. “Findings will determine the safety of intravenously administered aminocandin in humans. In vitro and animal studies with aminocandin have demonstrated activity against a broad range of fungi and the ability to protect against systemic fungal infections in an immune-compromised host. We also believe aminocandin has the potential to be administered orally, and we have initiated feasibility studies related to the development of an oral formulation.”
Echinocandins are the first new class of anti-fungal agents to be developed and introduced in more than 40 years. They 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.
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: trospium for overactive bladder, pagoclone for panic and generalized anxiety disorders, citicoline for ischemic stroke, 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.
Except for the descriptions of historical facts contained herein, this press release contains forward-looking statements that involve risks and uncertainties that could cause the Company’s actual results and financial condition to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties are set forth in the Company’s filings under the Securities Act of 1933 and the Securities Exchange Act of 1934 under “Risk Factors” and elsewhere, and include, but are not limited to: dependence on the success of trospium; the early stage of products under development; uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly trospium; risks associated with contractual agreements; dependence on third parties for manufacturing and marketing; competition; need for additional funds and corporate partners, including for the commercialization of trospium and for the development of pagoclone; failure to acquire and develop additional product candidates; history of operating losses and expectation of future losses; product liability and insurance uncertainties; risks relating to the Redux-related litigation; limited patent and proprietary rights; dependence on market exclusivity; valuation of our Common Stock; risks related to repayment of debts; risks related to increased leverage; and other risks.