MGI PHARMA Provides Update on Aquavan(R) Injection Program; Top Line Results of Successful Phase 2 Dose Ranging Study Summarized; Aquavan(R) Injection Pivotal Program Planned to Begin in Early 2006.MINNEAPOLIS -- MGI MGI Mouse Genome Informatics MGI Modular Gateway Interface MGI McKinsey Global Institute MGI Military Geographic Information MGI Marine Geological Institute MGI Policy on the Management of Government Information (Canada) PHARMA, INC inc - /ink/ increment, i.e. increase by one. Especially used by assembly programmers, as many assembly languages have an "inc" mnemonic. Antonym: dec. . (Nasdaq:MOGN), an oncology and acute care focused biopharmaceutical company, today announced top line results from a randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double-blind, multi-center phase 2 dose ranging study of Aquavan(R) (fospropofol disodium) Injection in patients undergoing colonoscopy. In addition, the Company provided an overview of the pivotal program that is intended to serve as a basis for registration of Aquavan Injection for use as a sedative sedative, any of a variety of drugs that relieve anxiety. Most sedatives act as mild depressants of the nervous system, lessening general nervous activity or reducing the irritability or activity of a specific organ. in patients undergoing procedures requiring minimal to moderate sedation. This pivotal program is planned to begin in early 2006. Phase 2 Dose Ranging Study A phase 2 dose ranging study was conducted to determine the dose-response relationship of Aquavan Injection for endpoints of sedation success, patient satisfaction, investigator satisfaction, and safety. A total of 127 adults undergoing colonoscopy were randomized to receive one of four different initial bolus bolus /bo·lus/ (bo´lus) 1. a rounded mass of food or pharmaceutical preparation ready to swallow, or such a mass passing through the gastrointestinal tract. 2. a concentrated mass of pharmaceutical preparation, e. doses of Aquavan Injection (2.0, 5.0, 6.5, or 8.0 mg/kg) or midazolam (0.02 mg/kg) following pretreatment pretreatment, n the protocols required before beginning therapy, usually of a diagnostic nature; before treatment. pretreatment estimate, n See predetermination. with fentanyl citrate fentanyl citrate n. A narcotic analgesic used as a supplementary analgesic agent in general anesthesia. fentanyl citrate Warning - High-alert drug! Sublimaze . Following administration of the initial bolus dose of study drug, the design of this trial allowed supplemental doses to be administered to reach and maintain minimal to moderate sedation during the procedure. Study drugs were administered by medical personnel as dictated by local investigative site guidelines; administration by an anesthesiologist Anesthesiologist A medical specialist who administers an anesthetic to a patient before he is treated. Mentioned in: Anesthesia, General, Appendectomy, Parathyroidectomy anesthesiologist was not required. The results of this dose ranging study show the 6.5 mg/kg and 8.0 mg/kg doses of Aquavan Injection were statistically superior to the 2.0 or 5.0 mg/kg bolus doses of Aquavan Injection with regard to the sedation success endpoint. In a blinded survey, investigators treating 92% of the patients receiving an initial bolus dose of 6.5 mg/kg indicated that they would again choose Aquavan Injection for procedures needing moderate sedation, compared to the responses of investigators administering the 8.0 mg/kg dose of Aquavan Injection (83%) or midazolam (77%). Data from this study also indicate that patients treated with Aquavan Injection required fewer supplemental doses to achieve initial sedation compared to those who received midazolam. More than 90% of patients who received Aquavan Injection required two or fewer supplemental doses during initiation of sedation, compared to 58% of patients who were treated with midazolam.
Sedation Adequacy of
Initial Dose-Study Drug Success(a) Sedation(b)
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2.0 mg/kg Aquavan Injection 24% 28%
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5.0 mg/kg Aquavan Injection 36% 50%
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6.5 mg/kg Aquavan Injection 75% 89%
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8.0 mg/kg Aquavan Injection 95% 83%
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0.02 mg/kg midazolam 81% 58%
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(a) Sedation success was defined as three consecutive Modified
Observer's Assessment of Alertness/Sedation (MOAA/S) scores
greater than or equal to 4 after administration of sedative
medication, completion of the colonoscopy procedure without the
use of alternative sedative medication, and completion of the
colonoscopy procedure without manual or mechanical ventilation.
(b) Adequacy of sedation prior to initiation of the procedure was
determined by blinded investigator survey.
"The data from this phase 2 study clearly indicate a dose response for Aquavan Injection and describe a promising therapeutic profile," stated Lonnie Moulder moul·der v. Chiefly British Variant of molder. moulder or US molder Verb to crumble or cause to crumble, as through decay: , President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of MGI PHARMA. "Aquavan Injection for minimal to moderate procedural sedation represents an excellent market opportunity for MGI PHARMA, as we continue to strengthen our acute care portfolio and advance our pipeline of late stage product candidates. We look forward to initiating a pivotal program for this product candidate in early 2006." Various measures of patient satisfaction were also analyzed as a part of this study. Patients were surveyed to determine the time needed to resume normal activities and food intake. The time to resumption of normal activities and food intake was shortest for patients who received an initial dose of 6.5 or 8.0 mg/kg Aquavan Injection in comparison to midazolam. Patients treated with an initial bolus of 6.5 or 8.0 mg/kg of Aquavan Injection were able to resume normal activity at least 2 hours (greater than 50%) sooner and eat an hour (greater than 40%) sooner than those treated with midazolam. Of those patients who received an initial dose of 6.5 mg/kg or 8.0 mg/kg Aquavan Injection, 100% and 83%, respectively, indicated that they were adequately sedated during the procedure, compared to 89% of patients treated with midazolam. Overall, 92% of the patients who received the 6.5 mg/kg dose of Aquavan Injection indicated the highest levels of satisfaction with their experience, compared to 79% of patients treated with the 8.0 mg/kg dose of Aquavan injection and 69% of patients treated with midazolam. No serious adverse events were reported and no adverse events led to procedure or study drug discontinuation during this trial. In addition, no patients in this study required manual or mechanical ventilation mechanical ventilation n. A mode of assisted or controlled ventilation using mechanical devices that cycle automatically to generate airway pressure. . The most common adverse events experienced were burning sensation and paraesthesia par·aes·the·sia n. Variant of paresthesia. . "We are encouraged that patients and investigators reported high levels of satisfaction with Aquavan Injection. Based on the sedation success outcomes combined with patient and investigator satisfaction survey results, we have decided to advance the 6.5 mg/kg dose of Aquavan Injection into a pivotal development program that will be designed to serve as the basis for FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. registration," said Mary Lynne Hedley, Sr. Vice President and Chief Scientific Officer of MGI PHARMA. "We plan to begin this program in early 2006 and expect that it will be completed within one year." Pivotal Clinical Development Program The pivotal development program for Aquavan Injection is expected to begin in early 2006 and will consist of two randomized, double-blind, multi-center phase 3 trials and an open label safety study. The first pivotal trial will enroll a total of 300 patients undergoing colonoscopy. The second pivotal study is planned to enroll 250 patients undergoing bronchoscopy Bronchoscopy Definition Bronchoscopy is a procedure in which a cylindrical fiberoptic scope is inserted into the airways. This scope contains a viewing device that allows the visual examination of the lower airways. . The endpoints of both pivotal trials include sedation and treatment success (as previously defined), patient satisfaction, investigator satisfaction, and measures of sedation adequacy, recovery, clinical benefit, and safety. In addition to the two pivotal trials, an open label, multi-center safety study will be conducted in 150 patients undergoing minor procedures, including arthroscopy Arthroscopy Definition Arthroscopy is the examination of a joint, specifically, the inside structures. The procedure is performed by inserting a specifically designed illuminated device into the joint through a small incision. , bunionectomy, dilation and curettage dilation and curettage n. Abbr. D & C A surgical procedure in which the cervix is expanded using a dilator and the uterine lining scraped with a curette, performed for the diagnosis and treatment of various uterine conditions. , endoscopy endoscopy Examination of the body's interior through an instrument inserted into a natural opening or an incision, usually as an outpatient procedure. Endoscopes include the upper gastrointestinal endoscope (for the esophagus, stomach, and duodenum), the colonoscope (for the , hysteroscopy, lithotripsy Lithotripsy Definition Lithotripsy is the use of high-energy shock waves to fragment and disintegrate kidney stones. The shock wave, created by using a high-voltage spark or an electromagnetic impulse, is focused on the stone. , shunt placement and trans-esophageal echoes. The goal of this study will be to assess the safety of a single dose of Aquavan Injection in a variety of minor surgical procedures. MGI PHARMA anticipates that enrollment in these three clinical trials will conclude in approximately one year. About Aquavan(R) (Fospropofol Disodium) Injection Aquavan (fospropofol disodium) Injection, a proprietary water-soluble prodrug prodrug /pro·drug/ (-drug) a compound that, on administration, must undergo chemical conversion by metabolic processes before becoming an active pharmacological agent; a precursor of a drug. of propofol that after intravenous injection is rapidly converted by an enzyme (alkaline phosphatase alkaline phosphatase /al·ka·line phos·pha·tase/ (ALP) (fos´fah-tas) an enzyme that catalyzes the cleavage of orthophosphate from orthophosphoric monoesters under alkaline conditions. ) in the body into propofol, is a product candidate in development for minimal to moderate sedation. Aquavan Injection has not been approved by the FDA or any other regulatory agencies. MGI PHARMA plans to initiate a pivotal clinical development program for Aquavan Injection in early 2006. About MGI PHARMA MGI PHARMA, INC. is an oncology and acute care focused biopharmaceutical company that acquires, researches, develops and commercializes proprietary products that address the unmet needs of patients. MGI PHARMA markets Aloxi(R) (palonosetron hydrochloride palonosetron hydrochloride Aloxi Pharmacologic class: Selective serotonin subtype 3 (5-HT3) receptor antagonist Therapeutic class: Antiemetic Pregnancy risk category B ) 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.This news release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 that 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 Form 10-Q See 10-Q. or 10-K. MGI PHARMA undertakes no duty to update any of these forward-looking statements to conform them to actual results. |
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