October 22, 2014, Vancouver, Canada â€” iCo Therapeutics (“iCo” or “the Company”) (TSX-V: ICO) (OTCQX: ICOTF), today announced next steps for its Oral Amphotericin B program. The company recently announced positive findings from its in vitrowork involving samples from HIV/AIDS patients exposed to HAART therapy. iCo now plans to complete pre clinical studies and regulatory filings to move forward with an initial Phase 1A clinical trial, utilizing approximately $700,000 of funding and technological advice from the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP), under the Canadian HIV Technology Development (CHTD) Program.
“Advancing the Oral Amphotericin B program follows the company’s long standing business plan to advance currently approved therapeutics by employing reformulation and delivery technologies for new or expanded use indications,” said Andrew Rae, President & CEO of iCo Therapeutics. “There is a growing interest in addressing the issue of flushing latent HIV reservoirs, in addition to life threatening fungal and parasitic infections which may be impacted by a novel and more accessible formulation of Amphotericin B. Numerous parties are now attempting to repurpose drugs for such purposes and Oral Amphotericin B represents one such approach. We are excited to complete pre-clinical toxicology studies and initiate Phase 1A work in human subjects. We are thankful for the support from NRC-IRAP CHTD, which leaves the company with a cash runway through to the first half of 2016, taking us to data on this first trial.”
The preparation and regulatory filings are expected to be completed in the second half of 2015, with initiation of a Phase 1A study early in the first quarter of 2016.
iCo has also been building its intellectual property position around the Oral Amphotericin B asset. The company was issued composition of matter and use patents, titled: Formulations for Oral Administration of Therapeutic Agents and Related Methods, issued in the United States, Russia, Singapore, New Zealand and notice of allowance in China. Management is aggressively pursuing further patent issuances in multiple jurisdictions as it moves towards the clinic.
Current Amphotericin B product, AmBisome, marketed by Gilead, had sales of $352 million in 2013, but it is severely limited in its application because of its toxicity and IV delivery. An oral delivery platform would open up the market for the treatment of infections and outpatient treatment regimes, as well as developing world treatments where IV is not practical.
About iCo Therapeutics
iCo Therapeutics in-licenses and redefines existing drug candidates or generics by employing reformulation and delivery technologies for new or expanded use indications. The Company has exclusive worldwide rights to iCo-007 and iCo-008, as well as an oral drug delivery platform. The first platform candidate being tested is the Oral Amp B Delivery system, utilizing a known anti-fungal drug to treat latent HIV reservoirs, parasitic and life-threatening infectious diseases. iCo trades on the TSX Venture Exchange under the symbol “ICO” and the OTCQX under the symbol “ICOTF”. For more information, visit the Company website at: www.icotherapeutics.com.
No regulatory authority has approved or disapproved the content of this press release. Neither the TSX Venture Exchange nor its Regulatory Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.
Forward Looking Statements
Certain statements included in this press release may be considered forward-looking statements” within the meaning of applicable securities laws. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “goal,” “seek,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will,” and similar references to future periods and includes, but is not limited to, statements about the intended use of proceeds of the Offering. 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’s current beliefs as well as assumptions made by and information currently available to iCo 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 are based only on information currently available to iCo and speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by iCo in its public securities filings and on its website, actual events may differ materially from current expectations. iCo disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Mr. John Meekison, CFO
Michael Moore, Investor Relations