IntraBiotics Pharmaceuticals, Inc., a biopharmaceutical company, announced plans to launch a 500 patient Phase II/III clinical study to investigate iseganan HCl in the prevention of ventilator-associated pneumonia (VAP). The company recently concluded a productive meeting with the Food and Drug Administration (FDA) to discuss the development of iseganan for VAP.
Ventilator-associated pneumonia is a common infection occurring among patients in the intensive care unit. Patients who require artificial ventilation are vulnerable to experiencing pneumonia as a consequence of the aspiration of bacteria-laden saliva.
Prior clinical trials using a variety of other antibiotics have demonstrated that VAP can be prevented through prophylactic decontamination of the oral cavity. Conventional antibiotics are not widely prescribed to prevent VAP because of concerns for the development of antibiotic resistance and because there are currently no approved therapeutics for the prevention of VAP. As a consequence, patients who develop VAP incur extended stays in the intensive care unit and increased hospital charges. In the United States, over 400,000 patients are artificially ventilated each year and are vulnerable to developing VAP because they require ventilation for at least 48 hours.
Iseganan is a novel antimicrobial peptide whose properties may be well suited for use in preventing VAP. Iseganan kills a wide spectrum of bacteria known to cause pneumonia. Additionally, iseganan has been shown to be well tolerated in clinical studies in cancer patients, and to effect significant reductions in the level of bacteria in the oral cavity of cancer patients as well as patients who require artificial ventilation.
In a previous Phase I/II study completed by IntraBiotics in artificially ventilated patients, iseganan reduced the levels of oral bacteria by more than 100-fold compared to pre-treatment baseline levels after a single 9 mg oral-topical dose. Data from the coming Phase II/III trial are expected in the second quarter of 2004.
In preparing for the upcoming launch of the Phase II/III clinical trial for VAP, the company has secured up to $3.5 million of financing commitments, subject to shareholder approval. When combined with existing cash, these proceeds are expected to assure sufficient funding through the completion of the Phase II/III VAP clinical trial and into the second half of 2004. The investors in the financing include Tang Capital Partners, LP, Baker Brothers Investments and Dr. Ernest Mario, the Company's chairman. The financing will be in the form of Series A Convertible Preferred Stock as well as warrants to purchase shares of Common Stock and the company intends to file a proxy statement with the SEC as a first step in the process of seeking shareholder approval for the transaction.
At the request of Dr. Mario, the Board of Directors has elected Henry J. Fuchs, MD, to the position of chief executive officer of the company. Previously, Dr. Fuchs was president and chief operating officer of the company. Dr. Mario will continue as chairman of the Board. “I felt it was important for the company to be led by an expert clinician. I am pleased that Dr. Fuchs has agreed to become the CEO to assure that our VAP clinical trial is executed on schedule and within the planned budget. I look forward to continuing my close association with IntraBiotics as chairman of the Board,” said Dr. Mario.
IntraBiotics is also in the process of seeking shareholder approval to effect a reverse split of its outstanding shares in the range of between 1-for-8 and 1-for-12, as may be determined by the Board after the shareholder approval, in the effort to support the minimum bid price maintenance requirement for listing on the Nasdaq National Market. The company expects to hold the shareholder meeting to solicit the shareholder approval of the reverse stock split and the financing, among other matters, late first quarter or early second quarter of 2003.