MIGENIX Reports Third Quarter Fiscal Year 2008 Financial Results
Jim DeMesa, M.D., President & CEO of MIGENIX stated, "With the conclusionof our third fiscal quarter and now being halfway through our fourth quarter,we are looking forward to the completion of enrollment in the Phase IIIOmigard registration trial for preventing catheter-related infections beingconducted by our partner, Cadence Pharmaceuticals. With completion of thistrial, we expect to enter into a very important time of clinical results overthe next half of the year (with both Omigard and celgosivir, our Phase IIhepatitis C drug candidate) followed by our potential entry into theregulatory approval process in 2009 with Omigard."
UPDATE ON DRUG DEVELOPMENT PROGRAMS
Omiganan 1% gel (Omigard(TM)/CPI-226/MX-226; topical cationic peptide;prevention of catheter-related infections): A pivotal Phase III study beingconducted by our development and commercialization partner CadencePharmaceuticals is in progress in the United States under a Special ProtocolAssessment (SPA) agreement with the US FDA and in Europe. Cadence expects theywill complete enrollment of the 1,850 patients planned for the trial in thesecond quarter of 2008, with results available in the second half of 2008. Ifthe results of the trial are positive, Cadence expects to submit a New DrugApplication ("NDA") for omiganan 1% gel in the first half of 2009. Under theterms of the agreement with Cadence, MIGENIX will receive up to US$27 millionin development and commercialization milestone payments, upon the achievementof specified milestones, starting with the US and European regulatorysubmission process; and a double-digit royalty on net sales. MIGENIX has beenand continues to be in discussions with potential partners for the rest ofworld (territories outside North America and Europe) rights held by MIGENIXalthough the timing and completion of such a partnership(s) is uncertain atthis time.
Celgosivir (MX-3253; oral alpha-glucosidase I inhibitor; treatment ofchronic hepatitis C virus infections): A Phase II study is currently enrollingpatients to assess 600 mg celgosivir for tolerability, pharmacokinetics andviral kinetics when combined with the standard of care drugs, pegylatedinterferon alfa-2b plus ribavirin, as compared to the standard of care drugsalone and to 400 mg celgosivir plus the standard of care for up to 12 weeks oftherapy. With 15 patients enrolled to date, it is planned that approximatelysix additional patients will be enrolled. In February, one of the two contractresearch organizations we were using to conduct this study shut downoperations unexpectedly. We are in the process of transferring the plannedoperations at this site including patients that have been qualified forenrollment to another clinical site, and obtaining the required InstitutionalReview Board approval for this site. We maintain our expectation for resultsfrom the study in the third calendar quarter of 2008. MIGENIX has been andcontinues to be in discussions with potential partners for the furtherclinical development of celgosivir although the timing and completion of apartnership is uncertain at this time.
Omiganan (CLS001; topical cationic peptide; treatment of dermatologicaldiseases): Based on positive results from a recently completed Phase IIclinical study for the treatment of rosacea, our partner in this program,Cutanea Life Sciences intends to enter Phase III clinical development laterthis calendar year.
MX-2401 (IV lipopeptide; treatment of gram-positive bacterial infections):MX-2401 is an injectable lipopeptide being developed for the treatment ofserious gram positive bacterial infections. To date, preclinical stu
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