Vancouver, British Columbia--(Newsfile Corp. - April 15, 2020) - iCo Therapeutics Inc. (TSXV: ICO) (OTCQB: ICOTF) ("iCo" or the "Company") announced today the successful results of a Phase 1b clinical study of iCo's Oral Amphotericen B Delivery System ("Amp B" or "iCo 019") which began on December 9, 2019. The purpose of the study was to evaluate the safety, tolerability and pharmacokinetics of 100mg and 400mg doses of iCo 019.
iCo also announced the appointment of Dr. Kishor Wasan as Director of Research for the Company. Dr. Wasan has received numerous awards for his contributions to health sciences including the Canadian Society of Pharmaceutical Sciences Leadership award for outstanding contributions to Pharmaceutical Sciences in Canada and is a Fellow of the Canadian Academy of Health Sciences and the American Association of Pharmaceutical Scientists. Dr. Wasan has published over 240 peer-reviewed articles and 280 abstracts in the area of lipid-based drug delivery and lipoprotein-drug interactions. Most recently, Dr. Wasan served as the Dean of the College of Pharmacy and Nutrition of the University of Saskatchewan from August 2014 to June 2019. Dr. Wasan led the research team at the Wasan lab at the University of British Columbia that developed what has become iCo 019, and will initially focus his efforts on the further development of iCo 019 via partnerships and collaborations. "We are delighted to have Kish formally onboard leading our research efforts. We've worked with him since the founding of the Company and will benefit from his proven research abilities and deep connectivity to the global pharmaceutical industry," noted William Jarosz, the CEO of iCo.
Commenting on the iCo 019 trial Dr. Wasan noted, "In the Phase Ib human clinical study all repeated doses of ICO-019 were well tolerated with no serious adverse events including no signs of GI, kidney or liver toxicities. ICO-019 at the 100 mg dose achieved a median plasma Cmax of 25 ng AmB/mL and AUC (0-inf) 990 hr* ng/mL after day 1 of dosing and a median plasma Cmax of 44 ng AmB/mL and AUC (0-inf) 1998 hr*ng/mL after 10 day of dosing. This approximate doubling of the AUC (0-inf) measure between day 1 and day 10 was observed not only at the 100 mg dose but at the 400 mg dose as well.
These data suggest that we may have developed a novel oral amphotericin B formulation that is safe and tolerable following multiple dosing to healthy human subjects. In addition, the increased AUC observed in the phase 1b human clinical studies between the day 1 of dosing to the day 10 of dosing suggests that iCO-19 formulation has the ability to increase and sustain Amphotericin B tissue concentrations within infected tissues without the associated GI, liver or kidney toxicity. I am pleased with the PK results from the Phase 1b trial."
In addition, iCo announced it will delay the start of the anticipated Phase 2 trial of iCo 019 as the result of uncertainty generated by the current COVID-19 events. "We are concerned that the ongoing pandemic could cause clinical challenges affecting our trial's timeline, leading to longer than expected delays and higher costs. Despite the positive findings of our Phase 1b trial, we believe it is the best use of our resources, and the resouces of our clinical research partners in the current environment, to delay the start of the Phase 2 trial until we have more clarity regarding the course of COVID-19 and its effect on clinical trial practices," stated Mr Jarosz.
About iCo Therapeutics
iCo Therapeutics identifies existing development stage assets for use in underserved ocular and infectious diseases. Such assets may exhibit utility in non-ophthalmic conditions outside the Company's core focus areas and if so the Company will seek to capture further value via partnerships. iCo shares trade on the TSX Venture Exchange under the symbol "ICO" and on the OTCQB 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.
Certain statements included in this press release may be considered "forward-looking information" within the meaning of applicable securities laws. Forward-looking information can be identified by words such as: "anticipate", "intend", "plan", "goal", "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will", "suggest" and similar references to future periods. 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. Forward-looking statements in this press release include statements relating to the Company benefitting from Dr. Wasan's proven research abilities and deep connectivity to the global pharmaceutical industry, the data from the Phase 1b clinical study of iCo 019 suggesting that the Company may have developed a novel oral amphotericin B formulation that is safe and tolerable following multiple dosing to healthy human subjects and that the iCO-19 formulation has the ability to increase and sustain Amphotericin B tissue concentrations within infected tissues without the associated GI, liver or kidney toxicity, and beliefs that delaying the start of the anticipated Phase 2 trial of iCo 019 being the best use of the Company's resources, and the resouces of the Company's clinical research partners in the current environment . 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.
iCo Therapeutics Inc.
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