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ICO - 2 billion a year drug revenue as per US biotech major

Gilead Sciences AmBisome(amphotericin B for liposome injection), were $621 million for the fourth quarter of 2016, compared to $523 million for the same period in 2015 (by intravenous only) highly toxic



ICO is by Oral

"Recently, we dosed our first subject with our novel Oral Amphotericin B (Oral AmpB) formulation. Strong recruitment has resulted in our dosing of all subjects in three of four cohorts, representing 24 of 32 Phase 1 study participants. We remain on track to finish dosing of all subjects by the end of Q2 2018" stated Andrew Rae, Chief Executive Officer of iCo Therapeutics. "Full analysis of study data is expected shortly afterwards in Q3 2018."


ICO THERAPEUTICS ANNOUNCES POSITIVE ORAL AMPHOTERICIN STUDY

iCo Therapeutics Inc. has successfully concluded preclinical studies involving its lead oral Amphotericin B candidate, including compelling safety data from its pivotal 14-day GLP (good laboratory practices compliant) toxicology study.

Data from its IND enabling 14-day GLP study conducted in Toronto, Ont., facilities revealed that oral administration of Amphotericin B at a dose levels of up to 600 milligrams per day once daily for 14 days was well tolerated with no toxicologically significant histological findings (n is equal to 38 subjects).
Data from a seven-day dose range finding study revealed no toxicities of oral Amphotericin B up to 1,000 mg/day and a previous bridging study showed oral bioavailability of Amphotericin B from iCo-010 and iCo-019 and iCo-022 was similar with no significant differences noted between the formulation groups.
iCo is positioned to dose human subjects in a phase 1 study in fourth quarter 2017.
Positive nine-month stability data for lead candidate have recently been generated by the company's contract manufacturer in Montreal, Canada.
iCo is currently soliciting requests for proposals from Australian contract research organizations, with vendor selection anticipated shortly to engage a party to run the company's phase 1 clinical trial. (Australia currently offers generous refundable tax credits which significantly lower overall costs for phase 1.)
Multiple partnering discussions continue with Chinese, European, North American and Indian biopharmaceutical firms involved in due diligence under non-disclosure agreements.


Company chief executive officer Andrew Rae stated: "Given our significant leveraging of grant money we now are at the cusp of early human studies with our oral Amphotericin B candidate. Amphotericin B is an approved and highly effective anti-fungal agent and therefore our mission is not to prove the value of the drug itself, but instead the efficacy of an oral delivery system."

Professor and dean Dr. Kishor M. Wasan from the University of Saskatchewan college of pharmacy and nutrition and adjunct distinguished scholar professor at UBC Pharmaceutical Sciences, co-inventor of the oral Amphotericin B technology, stated: "These very positive results confirm the ability to delivery Amphotericin B orally and in high enough tissue concentrations to elicit biological activity without significant toxicity. This is a major milestone for our technology as we look forward to the phase 1 clinical trials."

Positive bridging study involving iCo-010 and optimized formulations

This study was designed to determine the pharmacokinetics of 100 mg of amphotericin B following a single oral dose of iCo-010 and also iCo-019 and iCo-022, two additional optimized oral formulations of Amphotericin B. Tissue distribution of Amphotericin B 24 hours following three days of single oral dose per day dosing of optimized formulations of Amphotericin B in study subjects was also examined. The oral bioavailability of Amphotericin B from iCo-010 and iCo-019 and iCo-022 was similar with no significant differences noted between the formulation groups for Cmax, Tmax and AUC0-Tlast. The lack of a significant difference between the pharmacokinetic parameters for the three formulations suggests that each is capable of delivering similar levels of Amphotericin B into the plasma. The levels observed in some of the tissues in this study were similar to range of tissue concentrations of Amphotericin B, observed seven days following oral dosing in mice, tissue concentrations that were effective in producing a 69- to 96-per-cent reduction of fungal burden in a mouse model of systemic candidiasis (source: F. Ibrahim, O. Sivak, E.K. Wasan, K. Bartlett and K.M. Wasan. "Efficacy of an Oral and Tropically Stable Lipid-Based Formulation of Amphotericin B (iCo-010) in an Experimental Mouse Model of Systemic Candidiasis" Lipids in Health and Disease 12:158-163, 2013).

Positive seven-day dose ranging study

In a seven-day dose range finding study with the company's lead candidate (iCo-019), analysis of all generated data, including clinical observations, body weights, food consumption, clinical pathology, gross necropsy, organ weights and histopathology (kidneys and liver), revealed no test-item-related toxicity in subjects that were treated orally with Amphotericin B twice a day, 12 hours apart at daily dose levels of up to 1,000 mg/day.

Positive 14-day GLP toxicology study

This preclinical study assessed the toxicity and toxicokinetics of Amphotericin B, when administered orally to subjects daily for a 14-day period. This study also assessed the progression or regression of any effects following a 14-day treatment-free recovery period in animals of the vehicle control and high dose groups. The 14-day GLP toxicology study revealed that oral administration of Amphotericin B (iCo-019), at a dose levels of up to 600 mg/day once daily for 14 days, was well tolerated by male and female subjects with no toxicologically significant histological findings (n is equal to 38 subjects). There were no findings observed upon gross necropsy at the end of the treatment or recovery periods. The usage of oral formulation avoids infusion-related side effects associated with intravenous application of Amphotericin B.