July 21, 2009
VANCOUVER , Canada — iCo Therapeutics Inc. (TSX-V: ICO) is pleased to announce the appointment of Donald N. Buell, M.D., to Chair the Scientific Advisory Board (SAB) committee overseeing the development of iCo-009, iCo’s oral Amphotericin B program for life-threatening fungal and parasitic diseases. Dr. Buell was most recently the Senior Medical Director at Astellas Pharma Inc, and has held positions in the Anti-infective Drugs Group at Pfizer, the Division of Oncology and Radiopharmaceutical Drug Products in the Center for Drugs and Biologics at the US Food and Drug Administration (FDA).
Dr. Buell, with over 80 publications to his name, obtained his M.D. from Stanford University School of Medicine, Stanford, CA.
Dr. Buell’s career highlights
Dr. Buell has been involved at the medical director level in the filing of 10 primary or supplemental New Drug Applications (NDA’s), 8 of which have been approved, with 2 approvable but not pursued. The most recent (January 2008) are the approvals of Mycamine® (micafungin) for treatment of candidemia, disseminated candidiasis, peritonitis and abcesses. Earlier approvals were for esophageal candidiasis and prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplant. Other drugs approved after programs under his direction were fluconazole (Diflucan®), tacrolimus (Prograf®) and liposomal Amphotericin B (AmBisome®).
“We are very pleased to have such a high caliber drug developer join iCo’s SAB,” stated Andrew Rae, iCo’s President & CEO. “Dr. Buell’s enviable track record, and his work on some of the leading anti-fungal agents such as Diflucan® and Ambisome®, gives us enormous confidence in his ability to successfully shepherd projects through the NDA process. We are looking forward to working with him and benefiting from his input and connectivity in the anti-fungal space as we advance iCo-009 into a clinical program.”
Amphotericin B is a highly potent agent with anti-fungal and anti-parasitic activity. Currently, only intravenous formulations are approved for treatment use. iCo-009 is an oral formulation of Amphotericin B. In animal models, oral administration of iCo-009 has been shown to result in blood levels that are comparable to a known IV Amphotericin B product currently on the market. In Aspergillus fumigatus and Candida albicans rat models, iCo-009 has shown significant antifungal activity with no observable kidney toxicity as assessed by plasma creatinine concentrations. Also recently published was significant iCo-009 activity in an animal model of Visceral Leishmaniasis. iCo-009 was developed by Drs. Kishor & Ellen Wasan at the University of British Columbia.
iCo’s Board of Directors have granted Dr. Buell stock options to purchase 25,000 common shares in the capital stock of the Company exercisable for a period of five years at a price of $0.40 per share. The share options vest one-third immediately upon the date of grant, one-third will vest 6 months from the date of grant and the final one-third of the options will vest 12 months from the date of grant. Following regulatory approval, the Company will have 1,218,928 remaining options available for grant under the 2009 stock option plan.
About iCo Therapeutics
iCo Therapeutics Inc. is a Vancouver-based reprofiling company focused on redosing or reformulating drugs with clinical history for new or expanded indications. iCo has exclusive worldwide rights to three products. iCo-007 is a second generation antisense candidate licensed from Isis Pharmaceuticals. iCo-007 is currently in a Phase I trial in Diabetic Macular Edema patients with compelling early data. iCo-008 is a human monoclonal antibody against eotaxin-1 with Phase II clinical history, licensed from AstraZeneca/MedImmune. iCo-009 is an oral reformulation of a generic anti-fungal and anti-parasitic intravenous drug licensed from the University of British Columbia. To date, iCo has reported positive preclinical results for iCo-009. iCo Therapeutics trades on the TSX-Venture exchange under the symbol “ICO”. For more information, visit the company website at: www.icotherapeutics.com
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Forward Looking Statements
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