MINNEAPOLIS, May 23, 2007 (BUSINESS WIRE) -- MGI PHARMA, INC.
(NASDAQ:MOGN), a biopharmaceutical company focused in oncology and
acute care, today announced the presentation of results of a
successful pivotal phase 3 trial of Aquavan(R) (fospropofol
disodium) Injection in patients undergoing colonoscopy. Primary and
secondary efficacy endpoint results, as well as safety data, were
presented at Digestive Disease Week 2007 in Washington, D.C. by
Lawrence B. Cohen, MD, Department of Medicine/ Gastroenterology,
Mount Sinai School of Medicine, New York.
Aquavan Injection is a proprietary water-soluble prodrug of propofol that is in clinical development for moderate sedation of patients undergoing therapeutic and diagnostic procedures. Aquavan has not yet been approved for marketing by the U.S. Food and Drug Administration (U.S. FDA) or any other regulatory agencies.
"Aquavan has a favorable pharmacokinetic profile, making it possible to deliver a predictable concentration of sedative and achieve the desired level of sedation," said Dr. Cohen, a lead investigator of the trial.
Colonoscopy Results: Primary Endpoint of Sedation Success Achieved (Abstract W1451)
A randomized, double-blind, multi-center phase 3 pivotal trial was conducted to evaluate whether an Aquavan dosing regimen of 6.5 mg/kg would be safe and effective in providing moderate sedation in patients undergoing colonoscopy, compared to a 2.0 mg/kg Aquavan regimen. A total of 312 patients in 18 sites were pre-treated with fentanyl citrate (50 (mu)g) and then received either Aquavan 2.0 mg/kg, Aquavan 6.5 mg/kg or midazolam 0.02 mg/kg (2:3:1 ratio). Gastroenterologists administered the sedatives, as is consistent with a large percentage of routine colonoscopies. Patients were ages 18 and older and in varying states of health and sedation risk.
The results showed that 87% of patients who received an initial bolus dose of Aquavan 6.5 mg/kg achieved sedation success, which was defined by three consecutive Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores of greater than or equal to 4, plus completion of the procedure without the need for alternative sedative medications and manual or mechanical airway assistance. In comparison, 26% of patients who received Aquavan 2.0 mg/kg achieved sedation success (pless than0.001), while 69% who received midazolam 0.02 mg/kg achieved sedation success. MOAA/S scores measure a patient's sedation level.
Furthermore, 88% of patients in the Aquavan 6.5 mg/kg treatment arm achieved "treatment success," the secondary efficacy endpoint of the trial, meaning they completed their colonoscopy without requiring manual/mechanical ventilation and alternative sedative medication (non-study sedative(s) used because of inadequate sedation). By comparison, 28% of patients in the Aquavan 2.0 mg/kg treatment arm achieved treatment success (pless than0.001). In addition, the 6.5 mg/kg dose of Aquavan was associated with a lower rate of supplemental analgesic use (55% of patients required additional analgesic medication, compared to 77% receiving the 2.0 mg/kg dose, pless than0.001). The most common adverse reactions were paresthesias (abnormal neurological sensations, such as increased sensitivity, numbness, tingling, and burning) and pruritis (itching). These were generally mild in intensity, transient and self-limiting. Results from this pivotal phase 3 trial have been reported previously.
Physician/Patient Satisfaction (Abstract W1440) and Procedural Recovery (Abstract W1441) Analyzed
Additional endpoints of the phase 3 study were analyzed prospectively in two sub-analyses to assess physician- and patient-reported satisfaction as well as patients' cognition during recovery. In the first sub-analysis, physicians used a 10-point scale (1 = low, 10 = high) to rate their experience with both Aquavan doses at the end of the sed ation initiation phase (the period between the first administered dose and the start of the procedure, i.e., when the scope is inserted), and again at the end of the procedure (i.e., when the scope is removed). The results showed that physician satisfaction ratings were higher for Aquavan 6.5 mg/kg at the end of the procedure (median score 9, versus median score 4 for Aquavan 2.0 mg/kg, pless than0.001). In addition, patients completed a six-question satisfaction survey prior to discharge. Fewer patients who received Aquavan 6.5 mg/kg remembered the scope being inserted (32% versus 45% of patients who received Aquavan 2.0 mg/kg, pless than0.05).
In another sub-analysis, patients were given the Hopkins Verbal Learning Test-Revised (HVLT-R(TM)), an instrument that measures verbal learning and memory retention. Measures of time to fully alert (TTFA) and time to discharge (TTD) were also analyzed, and showed that patients who received Aquavan 6.5 mg/kg achieved a TTFA of 6.7 minutes and a TTD of 8.7 minutes. Among patients who received at least one dose of study drug and no alternative sedative medication, patients in the Aquavan 6.5 mg/kg treatment arm demonstrated a higher mean retention score than those in the midazolam group (70% versus 41%, p less than0.01).
Data from the phase 3 study, together with the results of another phase 3 trial in patients undergoing bronchoscopy and an open-label study in patients undergoing minor surgical procedures, will form the foundation of the Aquavan New Drug Application (NDA).
"There is a need for new agents for moderate sedation that offer an alternative to existing agents. Aquavan was designed to help fulfill this need," said Mary Lynne Hedley, Ph.D., Executive Vice President and Chief Scientific Officer of MGI PHARMA. "We are very pleased with the outcome of this trial and remain on track to submit the Aquavan New Drug Application to the U.S. Food and Drug Administration in the third quarter of this year."< /p>
About MGI PHARMA
MGI PHARMA, INC. is a biopharmaceutical company focused in oncology and acute care that acquires, researches, develops, and commercializes proprietary products that address the unmet needs of patients. MGI PHARMA markets Aloxi(R) (palonosetron hydrochloride) Injection, Dacogen(R) (decitabine) for Injection, and Gliadel(R) Wafer (polifeprosan 20 with carmustine implant) in the United States. The Company directly markets its products in the U.S. and collaborates with partners to reach international markets. For more information about MGI PHARMA, please visit www.mgipharma.com.
About Digestive Disease Week (DDW)
DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 19-24, 2007, at the Washington Convention Center, Washington, DC. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.
This news release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements are not guarantees of MGI PHARMA's future performance and involve a number of risks and uncertainties that may cause actual results to differ materially from the results discussed in these statements. Factors t hat might cause MGI PHARMA's results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, the ability of MGI PHARMA's product candidates to be proven safe and effective in humans, to receive marketing authorization from regulatory authorities, and to ultimately compete successfully with other therapies; continued sales of MGI PHARMA's marketed products; development or acquisition of additional products; reliance on contract manufacturing; changes in strategic alliances; continued access to capital; ability of MGI PHARMA to successfully complete the integration of Guilford with its existing operations; the risk that the perceived advantages of the Guilford transaction may not be achieved; and other risks and uncertainties detailed from time to time in MGI PHARMA's filings with the Securities and Exchange Commission including its most recently filed Form 10-Q or 10-K. MGI PHARMA undertakes no duty to update any of these forward-looking statements.
SOURCE: MGI PHARMA, INC.