IDEV Press Release
Indevus Announces Favorable Results of Phase I Clinical Trial of Aminocandin for Systemic Fungal Infections
June 09, 2004 08:56:00 AM ET
Indevus Pharmaceuticals, Inc. IDEV today announced that aminocandin, under development as a treatment for systemic fungal infections, was well tolerated among healthy volunteers in a Phase I clinical trial and demonstrated a prolonged duration of antifungal activity following single-dose therapy.
The trial was designed to test the safety and tolerance of rising single doses of intravenously administered aminocandin among approximately 40 healthy volunteers. Secondary objectives included the pharmacokinetic assessment of aminocandin in plasma and urine and determination of serum fungicidal activity.
Dose levels achieved during this trial were approximately seven-fold higher than the anticipated clinical dose and were all well tolerated. Of particular note was the absence of infusion-related histamine reactions, a recognized effect of other drugs in the echinocandin class, and the lack of a significant infusion-associated rise in plasma histamine levels, even at the highest doses and concentrations of administered drug. Furthermore, following single intravenous doses, significant fungicidal activity was observed in patients' serum samples for up to one week.
"We plan to build upon these results and initiate a multiple dose Phase I trial later this year to optimize the dosing level and regimen for advanced stage clinical testing," said Glenn L. Cooper, M.D., chairman, president and chief executive officer of Indevus. "Previous in vitro and animal studies with aminocandin have demonstrated activity against a broad range of fungi and the ability to treat systemic fungal infections in an immune-compromised host.
"The exciting results from this initial human study indicate the possibility that intravenous aminocandin might have a differentiated infusion-related safety profile compared to other echinocandins and that the compound might be amenable to a longer dosing regimen (e.g. once or twice weekly) than other echinocandins which are generally once-a-day drugs," said Dr. Cooper. "Intravenous aminocandin clearly has the potential to be one of the most important compounds within the Indevus portfolio. Furthermore, early-stage work continues on a development program to enhance the oral bioavailability of aminocandin for a possible future oral delivery 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. 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, 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, aminocandin for systemic fungal infections and citicoline for stroke.
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 SANCTURA; the early stage of products under development; uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly SANCTURA; risks associated with contractual agreements; dependence on third parties for manufacturing, particularly for SANCTURA, and marketing; competition; need for additional funds and corporate partners, including for the development of our other products; 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.
Contact Information: Indevus Pharmaceuticals Michael W. Rogers
William B. Boni
781-861-8444
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