VANCOUVER, Canada— iCo Therapeutics Inc. (TSX-V: ICO) is pleased to announce that the Company’s oral Amphotericin B program, “iCo-009”, has been granted Orphan Drug status for the treatment of Visceral Leishmaniasis (VL) by the US Food and Drug Administration (FDA).
The Orphan Drug Act (ODA) is intended to promote the development of products that demonstrate promise for the treatment of rare diseases or conditions. Orphan designation qualifies the sponsor of the product for tax and marketing incentives, which can include tax credits for clinical research, study design support, exemption from application-filing fees, grant funding for clinical trials, and seven years of marketing exclusivity after the approval of the drug.
“We are extremely pleased to have received Orphan status for iCo-009,” stated Andrew Rae, iCo Therapeutics. “We plan to take advantage of all available benefits and incentives to assist in funding and expediting the development of iCo-009”.
iCo plans to develop iCo-009 for both fungal and parasitic diseases in the developed and developing world. 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. iCo-009 was the subject of the first ever publication of an oral Amphotericin B eradicating the parasite responsible for VL (The Journal of Infectious Diseases Aug 2009 Volume 200(3): 357-360). Administration of the highest dose of iCo-009 resulted in 99.8% inhibition of the parasite. 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. Published preclinical studies have demonstrated significant efficacy of iCo-009 activity in rat fungal models (Aspergillosis and Candida) with no observable kidney toxicity. iCo-009 was invented by Drs. Kishor & Ellen Wasan at the University of British Columbia.
About Visceral Leishmaniasis (VL)
VL is a parasitic disease affecting 12 million people worldwide, with 500,000 new infections every year. VL is the second largest parasitic killer after malaria and if left untreated, it can have a fatality rate of 100% within two years (World Health Organization).
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, moving into Phase II for the treatment of DME, iCo-008; a product with Phase II clinical history to be developed for severe ocular allergies and age-related macular degeneration; and iCo-009, an oral formulation of Amphotericin B for sight and life-threatening diseases. iCo-009 also represents a new drug delivery technology with the potential to reprofile other parenteral administered drugs to the oral route of administration. iCo was recently awarded a Gold Leaf Award as the Early Stage Company of the Year from BIOTECanada and trades on the TSX Venture Exchange under the symbol “ICO”. For more information, visit the Company website at: icotherapeutics.cdmail.biz
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Forward Looking Statements
Certain statements included in this press release may be considered forward-looking. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on iCo Therapeutics’ current beliefs as well as assumptions made by and information currently available to iCo Therapeutics and relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by iCo Therapeutics in its public securities filings; actual events may differ materially from current expectations. iCo Therapeutics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.