iCo Therapeutics Provides Interim Trial Results (Diffuse Diabetic Macular Edema)



    VANCOUVER, Sept. 22 /CNW/ - iCo Therapeutics Inc. (TSX-V: ICO) is pleased
to report interim results from iCo's ongoing iCo-007 clinical trial. The phase
I, open-label, dose escalation study is evaluating the safety, tolerability,
and pharmacokinetics of a single intravitreal injection of iCo-007 in patients
with diffuse diabetic macular edema (DME).
    The primary objective of the study is to evaluate the safety and
tolerability of intravitreal iCo-007 in patients with diffuse DME. Other
objectives include assessment of systemic pharmacokinetics, changes in retinal
thickness using OCT measurements, and changes in visual acuity. The
advancement from one cohort to the next is dependent upon the trial's Safety
Evaluation Committee approval. iCo is mid-way through the trial and the Safety
Evaluation Committee has approved advancement to the third cohort. To date,
there have been no adverse events of concern.
    "We are greatly encouraged by the rolling data we are seeing from the
trial," stated Andrew Rae, iCo's President & CEO. "As this trial is in diffuse
DME patients rather than healthy volunteers, we are able to get a better
indication of the potential of iCo-007 compared to traditional Phase I
trials."

    About Diffuse DME

    DME is the swelling of the retina in diabetes patients due to leaking
blood vessels within the macula, the central portion of the retina that is
critical for daytime vision. Diffuse DME is caused by dilated retinal
capillaries throughout the posterior pole and it is typically more difficult
to handle than focal DME.
    There are currently no approved therapeutics for DME, the leading cause
of blindness in working age adults. DME affects approximately 1.6 million
people in the U.S. alone, a number that is expected to grow as Diabetes is
forecast to increase by almost 50% in the US by 2025.

    About iCo-007

    Designed and discovered by ISIS Pharmaceuticals Inc., (NASDAQ:   ISIS),
iCo-007 is a second-generation antisense inhibitor targeting c-Raf kinase mRNA
for the treatment of DME and Diabetic Retinopathy (DR). iCo licensed the
worldwide exclusive rights to all therapeutic applications of iCo-007 from
ISIS in 2005. DR and DME are characterized by new blood vessel growth and
increased vascular permeability. Drug products that prevent the growth of new
blood vessels and inhibit increased vascular permeability may have the
potential to treat neovascular diseases, including diabetic retinopathy and
diabetic macular edema. It is becoming more apparent that multiple growth
factors are implicated in the etiology of diabetic macular edema and diabetic
retinopathy and not only VEGF.
    iCo-007 may also be a potential treatment for certain oncology
indications, as c-Raf kinase is the predominant Raf isoform responsible for
regulating cellular growth in ovarian cancer.

    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, in
Phase I for the treatment of DME, iCo-008, a product with Phase II clinical
history to be developed for severe ocular allergies, and iCo-009, an 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 parenterally administered drugs to the oral route of
administration. iCo Therapeutics trades on the TSX-Venture exchange under the
symbol "ICO". For more information, visit the company website at:
HUwww.icotherapeutics.comU

    
    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.

    %SEDAR: 00024061E




For further information:

For further information: Business Development: Dr. John Clement, CT&DO,
(778) 688-0644, Finance Contact: Mr. John Meekison, CFO, (604) 602-9414 x 224;
Investor/Media Contact: Frederica Bell, Corp. Devt., (604) 602-9414 x 228; B&D
Capital, Joanne Calverley, (604) 685-6465

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iCo Therapeutics Inc.

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