http://www.icotherapeutics.com/index.php/site/index/ en bell@icotherapeutics.com Copyright 2008 2008-06-26T16:16:00-08:00 http://www.icotherapeutics.com/site/ico_therapeutics_reports_new_ico_009_oral_amphotericin_b_preclinical_result/ http://www.icotherapeutics.com/site/ico_therapeutics_reports_new_ico_009_oral_amphotericin_b_preclinical_result/#When:16:16:00Z VANCOUVER, Canada— iCo Therapeutics Inc. (TSX-V: ICO) is pleased to provide further preclinical results supporting the accelerated development of iCo-009, the company’s oral reformulation of Amphotericin B (Amp B). Amp B is a generic drug that has been in use for approximately 50 years, however its use is limited as it is currently administered intravenously and has significant infusion related side effects and kidney toxicity. The studies were conducted in a rat fungal model of Candida albicans in the laboratory of Dr. Kishor Wasan at UBC. Kidney and organ colony forming units (CFU) were used as an indicator of antifungal activity, and kidney toxicity was indirectly assessed by determining creatinine concentration in plasma. Significant antifungal activity was seen at dosage levels where no kidney toxicity was observed. The results will be submitted to a scientific journal in the coming months. “This data serves as further validation of iCo-009’s ability to safely kill fungal infections without the need to intravenously infuse Amphotericin B,” stated Andrew Rae, President & CEO of iCo Therapeutics. “These results not only corroborate those generated by Dr. Kish Wasan’s lab in the rat Aspergillus fumigatus model, but show an increasingly positive trend.” iCo-009 has the potential to treat not only systemic fungal infections, which have emerged as important causes of morbidity and mortality in immunocompromised patients (e.g., AIDS, cancer chemotherapy, organ or bone marrow transplantation), but also parasitical diseases such as Leishmaniasis in the developing world. iCo plans to develop iCo-009 under the 505(b)(2) section of the Federal Food, Drug, and Cosmetic Act, which expressly permits the FDA to reference safety data not developed by the applicant for approval of a New Drug Application (NDA). This approach can potentially reduce the development time and expense for approval of a drug. News 2008-06-26T16:16:00-08:00 http://www.icotherapeutics.com/site/ico_therapeutics_closes_1140450_financing/ http://www.icotherapeutics.com/site/ico_therapeutics_closes_1140450_financing/#When:00:04:00Z For Immediate Release June 9, 2008 VANCOUVER, Canada – iCo Therapeutics Inc. (TSX-V: ICO) announced today that it has closed a non-brokered private placement to raise gross proceeds of $1,140,450 through the issuance of 3,801,500 common shares at a price of $0.30 per share. The Company intends to use the net proceeds of the offering for general corporate purposes and working capital. A finder’s fee of 6% is payable to certain arm’s length third parties with respect to a portion of the private placement. All common shares issued in the private placement will be subject to a four month hold period, with the exception of 129,000 common shares that are not subject to a trading restriction. News 2008-06-10T00:04:00-08:00 http://www.icotherapeutics.com/site/ico_therapeutics_announces_1140450_financing/ http://www.icotherapeutics.com/site/ico_therapeutics_announces_1140450_financing/#When:00:27:00Z For Immediate Release June 2, 2008 VANCOUVER, Canada – iCo Therapeutics Inc. (TSX-V: ICO) announced today that it intends to complete a non-brokered private placement to raise gross proceeds of $1,140,450 through the issuance of 3,801,500 common shares at a price of $0.30 per share. The Company intends to use the net proceeds of the offering for general corporate purposes and working capital. A finder’s fee of 6% will be payable to certain arm’s length third parties with respect to a portion of the private placement. The private placement is expected to close on or about June 4, 2008 and is subject to regulatory approval, including the approval of the TSX Venture Exchange. News 2008-06-03T00:27:00-08:00 http://www.icotherapeutics.com/site/ico_therapeutics_first_quarter_financial_results/ http://www.icotherapeutics.com/site/ico_therapeutics_first_quarter_financial_results/#When:00:25:00Z For Immediate Release May 30, 2008 VANCOUVER, Canada— iCo Therapeutics Inc. (TSX-V: ICO) today reported interim financial results (unaudited) for the three months ended March 31, 2008. Amounts, unless specified otherwise, are expressed in Canadian dollars and in accordance with Canadian Generally Accepted Accounting Principles (Canadian GAAP). Summary Q1 2008 Results Selected Statement of Operations Data (see attached file) 2008.05.30_iCo_Q1.pdf We incurred a net loss of $769,576 for the three months ended March 31, 2008 compared to a net loss of $868,877 for the same period in 2007, representing a decrease of approximately $99,301. The decrease in our net loss was principally caused by a decrease in research and development expenses for the three months ended March 31, 2008 partially offset by an increase in amortization and stock based compensation expense. Interest income for the three months ended March 31, 2008 was $10,300, compared to $11,548 for the three months ended March 31, 2007. Research and development expenses were $437,975 for the three months ended March 31, 2008 compared to $623,114 for the same period in 2007, representing a decrease of $185,139. The decrease in research and development expenses was primarily due to the fact that we did not incur any costs related to the manufacturing of drug products during the three months ended March 31, 2008 other than ongoing stability testing for iCo-007, whereas during the three months ended March 31, 2007 we incurred expenses in connection with the manufacturing of drug product for Phase I clinical trials for iCo-008. For the three months ended March 31, 2008 general and administrative expenses were $267,916 compared to $251,375 for the same period in 2007, representing an increase of $16,541. This increase was primarily a result of increased staffing related to our public company activities. However, these added public company expenses were partially offset by reduced professional fees for the three months ended March 31, 2007. We realized a net cash outflow of $804,571 for the three months ended March 31, 2008 reflecting overall operating costs for the company. This compares to a net cash inflow of $1,246,127 for the three months ended March 31, 2007, which was principally due to financing proceeds of $2,521,743 offset by cash outflow from operations and investing activities of $1,275,616. Liquidity and Outstanding Share Capital As at March 31, 2008, we had cash and cash equivalents of $1,127,904 compared to $1,931,407 as at December 31, 2007. For complete financial results, please see our filings at http://www.sedar.com. News 2008-05-31T00:25:00-08:00 http://www.icotherapeutics.com/site/ico_therapeutics_acquires_worldwide_rights_to_ico_009_oral_amphotericin_b/ http://www.icotherapeutics.com/site/ico_therapeutics_acquires_worldwide_rights_to_ico_009_oral_amphotericin_b/#When:13:49:00Z For Immediate Release May 7, 2008 VANCOUVER, Canada— iCo Therapeutics Inc. (TSX-V: ICO) is pleased to announce that the company has acquired the exclusive worldwide rights to iCo-009, an oral reformulation of Amphotericin B (“Amp B”) for the treatment of systemic fungal infections and Leishmaniasis. AmpB is a generic drug that has been in use for approximately 50 years and is considered one of the most effective agents in the treatment of systemic fungal infections. Current use of Amp B is limited as it is currently administered intravenously and has significant infusion related side effects and kidney toxicity. The oral reformulation, iCo-009, was invented in the Wasan Lab at the University of British Columbia (UBC) by Drs. Kishor and Ellen Wasan. “iCo’s innovative partnership with UBC illustrates the forward thinking and leading edge nature of both our organizations,” stated Andrew Rae, iCo’s President & CEO. “iCo views the enormous market and compassionate use potential of a novel, oral Amphotericin drug as a win-win scenario for shareholders and our global community alike.” About Fungal Infections & Leishmaniasis It has been estimated that fungal infections may account for up to 30% of deaths in immunocompromised individuals, particularly those patients with cancer, AIDS, diabetes, and organ transplant recipients. In the developing world, AmpB is also an effective weapon against Leishmaniasis, a parasite contracted by approximately 2 million people a year, with 12 million presently infected worldwide. If left untreated, Visceral Leishmaniasis can have a fatality rate as high as 100% within two years (World Health Organization). News 2008-05-07T13:49:00-08:00 http://www.icotherapeutics.com/site/ico_therapeutics_to_present_at_biofinance_20081/ http://www.icotherapeutics.com/site/ico_therapeutics_to_present_at_biofinance_20081/#When:21:32:00Z For Immediate Release May 5, 2008 VANCOUVER, Canada— iCo Therapeutics Inc. (TSX-V: ICO) announces that Andrew Rae, iCo’s President and Chief Executive Officer, will provide an update on the Company’s progress at BioFinance 2008. Mr. Rae’s presentation will take place on Wednesday, May 7th at 3:00 p.m. EDT in the Trinity IV Room of the Toronto Marriott at Eaton Centre. BioFinance is the Canadian Life Science industry’s leading investor conference. News 2008-05-05T21:32:00-08:00 http://www.icotherapeutics.com/site/ico_therapeutics_year_end_2007_financial_results/ http://www.icotherapeutics.com/site/ico_therapeutics_year_end_2007_financial_results/#When:21:35:00Z For Immediate Release April 28, 2008 VANCOUVER, Canada— iCo Therapeutics Inc. (TSX-V: ICO) today reported financial results for the year ended December 31, 2007. Amounts, unless specified otherwise, are expressed in Canadian dollars and in accordance with Canadian Generally Accepted Accounting Principles (Canadian GAAP). “2007 was an important year for iCo”, stated Andrew Rae, iCo’s President & CEO. “We expanded and matured our product portfolio to reflect our risk-mitigating strategy, and the company is now focused on enhancing the value of iCo’s existing therapeutic assets for our shareholders.” 2007 Operating Highlights • iCo initiated a Phase I clinical trial for iCo-007, a second-generation antisense candidate for diabetic macular edema. • iCo completed a reverse takeover transaction (“RTO”) with Beanstalk Capital Ltd., taking iCo public on the TSX-Venture exchange. • iCo obtained an exclusive option on iCo-009, an oral reformulation of Amphotericin B, from the University of British Columbia. • iCo obtained an exclusive worldwide license for CAT-213, (now iCo-008), a human monoclonal antibody with Phase II clinical history, and completed a round of manufacturing of drug substance to enable further Phase II clinical studies. Summary Fiscal 2007 Results We recorded a net loss of $5,187,359 ($0.41 per common share) for the year ended December 31, 2007 compared to a net loss of $2,539,530 ($0.28 per common share) for fiscal 2006. The increase in net loss for fiscal 2007 compared to fiscal 2006 was primarily due to increases in both research and development expenses and general and administrative expenses as a result of increased operational activity for the company in 2007. The results of operations were in line with management’s expectations. Interest income for the year ended December 31, 2007 was $40,254 compared to $25,102 for the year ended December 31, 2006 due to a higher surplus cash balance in 2007. Research and development expenditures were $3,714,665 for fiscal 2007, compared to $1,760,011 for fiscal 2006. The increase in research and development expenses was largely attributable to increased costs relating to consultants and contract research organization expenses as iCo-007 entered into a Phase I clinical trial; and consultant and contract manufacturing expenses related to the manufacture of iCo-008 drug product in preparation for a Phase II clinical trial. General and administration expenses increased to $963,695 in fiscal 2007 from $513,567 in fiscal 2006. This increase is primarily a result of significant professional fees incurred related to the Company’s initial public offering attempt in the first half of 2007 and the RTO completed in the fourth quarter of 2007. Amortization was $114,864 for fiscal 2007 compared to $69,068 for fiscal 2006. Stock-based compensation increased to $203,883 for the year, as compared to $190,578 for 2006. Liquidity and Outstanding Share Capital As of December 31, 2007, the Company had cash, cash equivalents and short-term investments of $1,931,407. As of December 31, 2007, the Company had 17,913,181 common shares issued and outstanding and 1,531,072 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $0.42 per share. For complete financial results, please see our filings at http://www.sedar.com. News 2008-04-28T21:35:00-08:00 http://www.icotherapeutics.com/site/ico_therapeutics_ico_007_diabetic_macular_edema_poster_presentation_at_arvo/ http://www.icotherapeutics.com/site/ico_therapeutics_ico_007_diabetic_macular_edema_poster_presentation_at_arvo/#When:14:06:01Z VANCOUVER, Canada— iCo Therapeutics Inc. (TSX-V: ICO) announces that the company’s Diabetic Macular Edema (DME) candidate, “iCo-007”, will be presented by Dr. Peter Hnik in a poster session at the Association for Research in Vision and Ophthalmology Annual Meeting (ARVO). The poster, “iCo-007, a VEGF “+” Agent for the Potential Treatment of Diabetic Macular Edema and Diabetic Retinopathy”, can be viewed during the Macular Edema in Diabetes poster session on Tuesday, Apr 29, 2008 from 3:00 PM – 4:45 PM in Hall B/C of the Greater Fort Lauderdale Convention Center. Dr. Peter Hnik, iCo Therapeutics’ Chief Medical Officer, will be in attendance to respond to questions. Designed and discovered by ISIS Pharmaceuticals Inc., (NASDAQ: ISIS), iCo-007 is a second-generation antisense inhibitor targeting c-Raf kinase mRNA for the treatment of DME and Diabetic Retinopathy. iCo licensed the worldwide exclusive rights to all therapeutic applications of iCo-007 from ISIS in 2005. “DME is an unmet medical need representing vast market potential for novel compounds such as iCo-007”, said Andrew Rae, iCo’s President & CEO. “It is our hope that iCo-007’s ongoing Phase I trial in DME patients will represent a vital step in developing a treatment for this increasingly prevalent disease.” About iCo-007 iCo-007 is expected to decrease swelling in the retina and related visual impairment by decreasing the signaling of multiple growth factors, including VEGF, IGF, bFGF, EPO and HGF that signal through the c-Raf kinase / MAP kinase pathway. iCo-007 is currently in an open label, dose escalating Phase I clinical trial in DME patients. The primary endpoint of the trial is safety, with visual acuity and measures of retinal thickness serving as secondary endpoints. iCo-007 may also be a potential treatment for certain oncology indications, as c-Raf kinase is the predominant Raf isoform responsible for regulating cellular growth in ovarian cancer. About Diabetic Macular Edema There are currently no approved therapeutics for DME, the leading cause of blindness in working age adults. DME currently affects about 1.6 million people in the U.S. alone, a number that is expected to grow as Diabetes is forecast to increase by almost 50% in the US by 2025. News 2008-04-25T14:06:01-08:00 http://www.icotherapeutics.com/site/ico_therapeutics_announces_ico_009_oral_amphotericin_b_fda_meeting/ http://www.icotherapeutics.com/site/ico_therapeutics_announces_ico_009_oral_amphotericin_b_fda_meeting/#When:14:12:00Z VANCOUVER, Canada— iCo Therapeutics Inc. (TSX-V: ICO) announces the granting of a Pre-IND meeting by the United States Food and Drug Administration (FDA) for its iCo-009 formulation. iCo-009 is a novel oral formulation of the generic drug Amphotericin B, offering potential safety and dosing benefits in pre-clinical testing conducted to date. Pre-IND meetings represent a unique opportunity to gain FDA guidance in regards to overall clinical development plans. In this instance a clinical path and proposed 505(b)(2) strategy for iCo-009 will be discussed. “iCo continues to be impressed by the pre-clinical data generated by the Wasan lab at the University of British Columbia (UBC)” stated Andrew Rae, President & CEO of iCo Therapeutics. “Input from the FDA will allow us to further refine and optimize our proposed clinical plan and ensure we are on the most efficient roadmap to approval.” The Pre-IND meeting will be held on Friday May 2nd, 2008. About iCo-009 iCo-009 represents a new drug delivery technology with the potential to reprofile other parenteral drugs to the oral route of administration. News 2008-04-21T14:12:00-08:00 http://www.icotherapeutics.com/site/ico_therapeutics_ico_009_oral_amphotericin_b_published_in_leading_drug_deli/ http://www.icotherapeutics.com/site/ico_therapeutics_ico_009_oral_amphotericin_b_published_in_leading_drug_deli/#When:14:07:01Z VANCOUVER, Canada— iCo Therapeutics Inc. (TSX-V: ICO) is pleased to announce that iCo-009 has been highlighted in a leading drug delivery journal, Advanced Drug Delivery Reviews. The paper discusses the development of a novel oral Amphotericin B (AmpB) formulation (“iCo-009”) with significant antifungal activity, minimal kidney toxicity, and enhanced oral absorption of AmpB. The publication, “Enhanced drug absorption using lipids: A case study presenting the development and pharmacological evaluation of a novel lipid-based oral Amphotericin B formulation for the treatment of systemic fungal infections”, provides further detail on the potential mechanisms by which oral iCo-009 knocks down fungal infections. Publication highlights: • iCo-009 significantly decreased (95%) organ fungal concentration of Aspergillus fumigatus compared to controls in the brain and the spleen, two organs where Aspergillus fumigatus typically localizes in this animal model. • iCo-009 shows enhanced gastrointestinal tract absorption, plasma concentration, and tissue distribution. • iCo-009 shows minimal renal toxicity. • iCo-009 significantly decreased plasma galactomannan antigen levels. Detection of galactomannan in the blood can be used to diagnose Aspergillus fumigatus infections in humans. “iCo continues to be impressed by the work of Drs. Kishor & Ellen Wasan,” stated Andrew Rae, President & CEO of iCo Therapeutics. “Their work continues to improve upon the iCo-009 formulation represented in the paper, with newer formulations showing even more dramatic anti-fungal activity and bioavailability. iCo-009 has the potential to treat not just systemic fungal infections, but also parasitical diseases such as Leishmaniasis in the developing world. iCo remains very committed to UBC’s global access policy and we look forward to proceeding with development in both markets.” iCo has an option agreement with The University of British Columbia (UBC) for iCo-009’s development, which also represents a new drug delivery technology with the potential to reprofile other IV administered drugs to the oral route of administration. iCo plans to develop iCo-009 under the 505(b)(2) section of the Federal Food, Drug, and Cosmetic Act, which expressly permits the FDA to reference safety data not developed by the applicant for approval of a New Drug Application (NDA). Reference: The paper is available in the March 17, 2008 edition of Advanced Drug Delivery Reviews. K. Sachs-Barrable, S. Lee, E. Wasan, S. Thornton, K. Wasan. Advanced Drug Delivery Reviews 60 (2008) 692–701. News 2008-03-17T14:07:01-08:00