VANCOUVER, Jan. 21 /CNW/ - iCo Therapeutics Inc. (TSX-V: ICO) is pleased
to provide an update on the Company's iCo-009 program, an oral reformulation
of Amphotericin B (AmpB) for the treatment of systemic fungal infections and
Visceral Leishmaniasis. AmpB 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. 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.
Research studies conducted by Dr. Kishor M. Wasan's laboratory at UBC
continue to indicate that orally-administered iCo-009 reaches therapeutic
levels in the bloodstream and exhibits dramatic knock-down of fungal infection
with reduced or no kidney toxicity in animal models.
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). According to the FDA, this approach is "intended to
encourage innovation without creating duplicate work" and reflects the
principle that "it is wasteful and unnecessary to carry out studies to
demonstrate what is already known about a drug". This approach can potentially
reduce the development time and expense for approval of a drug such as
iCo-009, which is based upon a drug with a 50-year history.
Dr. Wasan recently published an article in Nature Reviews Drug Discovery
(Wasan, KM. et al. "Impact of lipoproteins on the biological activity and
disposition of hydrophobic drugs: implications for drug discovery" published
in the January 2008 Issue with a feature on the cover page). Dr. Wasan's
article further identifies the need for a novel formulation of AmpB and
demonstrates his laboratory's leadership in developing a formulation that
seems to be safe, can be stored in a more stable form and be taken orally,
greatly increasing the accessibility of AmpB treatment.
"We are thrilled to be working with a scientist of Dr. Wasan's caliber
and the results coming out of his laboratory continue to excite us," stated
Andrew Rae, President & CEO of iCo Therapeutics. "The opportunity to reprofile
an existing drug into a more accessible and efficacious formulation is
precisely what we are hoping to achieve with iCo's business model."
Dr. Wasan is Professor and Chair of Pharmaceutics and Biopharmaceutics, a
Distinguished University Scholar at UBC, and Canadian Institutes of Health
Research University-Industry Research Chair in Drug Development in the Faculty
of Pharmaceutical Sciences.
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. Amphotericin B
remains one of the most effective agents in the treatment of systemic fungal
infections. 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). iCo is committed to UBC's global access objectives,
which include broadening the societal impact of, and global access to, UBC
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 two products, iCo-007, in
Phase I for the treatment of Diabetic Macular Edema, and iCo-008, a product
with Phase II clinical history to be developed for severe ocular allergies.
iCo Therapeutics also has an exclusive option to license iCo-009, a oral
reformulation of Amphotericin B for sight and life-threatening diseases.
iCo-009 also represents a new drug delivery technology with the potential to
reprofile other IV administered drugs to the oral route of administration.
iCo Therapeutics trades on the TSX-Venture exchange under the symbol
For more information, visit the company website at:
No regulatory authority has approved or disapproved the content of this
release. The TSX Venture Exchange does not accept responsibility for the
adequacy or accuracy of this release.
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.
For further information:
For further information: Business Development Contact: Dr. John Clement,
CT&DO, (778) 688-0644; Finance Contact: Mr. John Meekison, CFO, (604) 602-9414
x 224; Investor/Media Contact: Frederica Bell, Corporate Development, (604)
602-9414 x 228, (778) 385-2549