VANCOUVER, Oct. 22, 2014 /PRNewswire/ - 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 vitro work 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.
SOURCE iCo Therapeutics Inc.
