CLARIFICATION: iCo Therapeutics Announces Positive Study Results and Significant Advances related to Oral Amphotericin B Program
Montag, 28.11.2016 17:55 von DGAP
DGAP-News: iCo Therapeutics Inc. / Key word(s): Miscellaneous
CLARIFICATION: iCo Therapeutics Announces Positive Study Results and
Significant Advances related to Oral Amphotericin B Program
28.11.2016 / 17:53
The issuer is solely responsible for the content of this announcement.
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Vancouver, British Columbia--(Newsfile Corp. - November 28, 2016) - iCo
Therapeutics (TSXV: ICO) (OTCQX: ICOTF) ('iCo' or 'the Company'), announces
several developments related to its novel, patent protected formulation of
generic Amphotericin B:
- Positive Oral Amphotericin B (Oral Amp B) study results exhibited
pharmacokinetic (PK) and tissue accumulation data with clinical and
commercial relevance:
- demonstrating scalable and stable drug product, now at a higher
dose form
- once daily regime may be possible for our drug candidate in certain
indications
- targeting treatment of multiple fungal indications, latent HIV
reservoirs, and certain developing world parasitic conditions
- complimenting existing drugs such as liposomal intravenous
Amphotericin B (IV Amp B) with global sales estimated to be in
excess of $400M USD in 2016.*
- *
http://www.gilead.com/news/press-releases/2016/4/gilead-sciences-an
nounces-first-quarter-2016-financial-results
- * https://www.astellas.com/en/ir/ar2016/pdf/2016AR_51_en.pdf
- Company anticipates a grant funding increase from existing sources
through March 31, 2017 which will allow completion of pivotal IND
enabling study and entrance into Phase 1a study with no impact on
corporate financial runway
- Timelines for completion of Phase 1a study in 2017
- iCo is now engaged in multiple strategic partnering discussions related
to Oral Amp B candidate
- Multiple filings of new intellectual property related to iCo's novel
carrier system utilized with our Oral Amp B candidate, including
coverage of formulations comprising protease inhibitors and uses for
the treatment of HIV
'Given our significant progress in contract manufacturing and pre-clinical
development we have a highly differentiated Oral Amp B lead candidate
rapidly making its way into the clinic' stated Andrew Rae, President and
CEO. 'Assuming clinical data reflects meaningful pre-clinical outcomes we
believe we may address anti-fungal markets in excess of a billion dollars
with an asset that makes administration far more accessible to a broad
population.' **
**
https://www.reportbuyer.com/product/2212016/antifungal-drugs-technologies-a
nd-global-markets.html
'I look forward to the entrance of our Oral Amp B candidate into clinical
trials and I am pleased to see continued promising results from our
pre-clinical study recently completed', stated Kishor Wasan Professor and
Dean, College of Pharmacy and Nutrition at the University of Saskatchewan
and Adjunct Professor and Distinguished Scholar at the University of
British Columbia, and co-inventor of the technology with Dr. Ellen Wasan.
Background
- IV Amp B is a drug of choice for certain life threatening systemic
fungal infection
- IV Amp B efficacy is well documented
- Early evidence to suggest that Amp B may activate latent HIV reservoirs
which could improve current and future anti-viral therapy outcomes.
- Need for oral formulation, preferably a solid dosage form with modest
administration burden, exists
Summary of Manufacturing and Experimental Results
New oral formulation prototypes were developed and tested in a pre-clinical
model. Rate of absorption and tissue accumulation was compared to original
prototype which has shown excellent results in multiple pre-clinical models
including Candida, Aspergillosis and Visceral Leishmaniasis. Stability data
is now approaching month six for our lead clinical candidate and ease of
manufacturing scale up should provide additional product differentiation.
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, such as
its partnership with Immune Pharmaceuticals (NASDAQ: IMNP), which is in
several Phase 2 studies involving iCo-008. iCo shares trade on the TSX
Venture Exchange under the symbol 'ICO' and on 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. 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.
Contact:
Andrew Rae, CEO
778-772-7775
rae@icotherapeutics.com
Click on, or paste the following link into your web browser, to view
the associated documents
http://www.newsfilecorp.com/release/23775
News Source: Newsfile
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28.11.2016 Dissemination of a Corporate News, transmitted by DGAP - a
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Language: English
Company: iCo Therapeutics Inc.
Canada
ISIN: CA45107J1057
End of News DGAP News Service
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524907 28.11.2016