TWIN FALLS, Idaho, Dec. 1 /PRNewswire-FirstCall/ -- Medical Discoveries, Inc. (BULLETIN BOARD: MLSC) announced today that it has filed an Investigational New Drug (IND) application with the FDA for a Phase I clinical trial of the company's proprietary drug MDI-P in late-term cystic fibrosis (CF) adults.
MDI-P will be tested as an adjunct therapy to inhaled Tobramycin (TOBI)*, an antibiotic used to treat infections caused by many different bacteria. Most late-term adult CF patients are dependent upon this inhaled form of Tobramycin, manufactured by Chiron Corporation.
Dr. Henry R. Thompson, Director of the CF Program Therapeutics Center at the Idaho Cystic Fibrosis Clinic, located at St. Luke's Regional Medical Center in Boise, will serve as Project Manager and Principal Investigator for MDI's Phase I trials.
Judy Robinett, President & Chief Executive Officer of MDI, stated: "This IND represents the accomplishment of a key objective for 2004 which we listed in January of this year and refined last August. We hope to have prompt FDA approval so that this clinical study can commence in Q1 of 2005. Its duration should be approximately six months."
Robinett continued: "MDI has been pursuing commercialization of MDI-P through a strategy of developing clinical studies in CF, followed by HIV and, later in 2005, asthma. Once we have approval for our CF IND, we hope to follow with an IND for HIV."
Formed in 1991, Medical Discoveries, Inc. is a publicly traded (OTC Bulletin Board as MLSC) development-stage biopharmaceutical research company engaged in the research, development and validation of its patented anti-infective technology. MDI's electrolyzed solution of free radicals represents a novel approach to treating its initial target indications, Cystic Fibrosis and HIV.
Information in this press release relating to the potential of MDI constitutes forward-looking statements. Actual results in future periods may differ materially from the forward-looking statements because of a number of risks and uncertainties set forth in MDI's 2003 Annual Report on Form 10-KSB and other filings with the Securities and Exchange Commission.
For Additional Information:
See MDI Press Releases at: http://www.medicaldiscoveries.com/
May 20, 2004 Medical Discoveries Inc. Announces Receipt of Cystic
Fibrosis Pre-Clinical Report on MDI-P
August 4, 2004 Medical Discoveries Inc. Announces Multiple Clinical
Development Priorities Under A Drug Master File
Sept. 23, 2004 Medical Discoveries Inc. Announces Clinician And Site For
Phase One Clinical Studies In CIF
* TOBI is a registered trademark of Chiron Corporation.
Medical Discoveries Inc.