Ongoing IND-enabling Non-clinical Program to Support the Use
of Cytisine in Smoking Cessation
Multiple Key Cytisine Development and Regulatory Milestones
Expected in 2017
MILL VALLEY, Calif.,
BOTHELL, Wash. and VANCOUVER, British Columbia, March 1, 2017 /PRNewswire/ -- Achieve Life
Science, Inc. (Achieve) and OncoGenex Pharmaceuticals, Inc.
(NASDAQ: OGXI) (OncoGenex) today announced a strategic
collaboration with the National Center for Complementary and
Integrative Health (NCCIH) at the National Institutes of Health
(NIH) to conduct non-clinical studies in support of an overall
clinical development plan for cytisine as a smoking cessation
treatment.
As part of the collaboration, Achieve is providing cytisine to
the NIH to conduct a series of non-clinical studies required by the
U.S. Food and Drug Administration (FDA) to support the submission
of an Investigational New Drug (IND) application. The collaboration
commenced in March 2015 and results
of the initial study are expected in the second-quarter of
2017.
"Given the burden of smoking-related illnesses and existing
preliminary data that indicates efficacy and safety, we consider
cytisine to be a potential drug of public health importance," said
David Shurtleff, Ph.D., NCCIH Deputy
Director. "We are hopeful that our research collaborations will
lead to more smoking cessation aids and reduce the number of lives
lost due to tobacco smoking and nicotine addiction."
According to the U.S. Surgeon General's 2014 report1
"The Health Consequences of Smoking – 50 years of Progress", there
are more than 16 million Americans living with a disease caused by
smoking and it is responsible for more than 480,000 deaths per
year. The Report states that productivity losses from premature
death exceed $150 billion per year
and the annual costs of direct medical care of adults attributable
to smoking are estimated to be over $130
billion.
Rick Stewart, Chairman and Chief
Executive Officer of Achieve commented, "We are delighted that the
NIH has provided assistance to Achieve in updating the non-clinical
package for cytisine. We intend to file the IND in the second half
of 2017. Phase 1 studies are expected to commence later in the year
and a Phase 3 trial is expected to start in the first half of
2018."
Two recent, large-scale clinical studies of cytisine, with
favorable outcomes, have been successfully completed in over 2,000
patients. The TASC trial was a 740 patient, double-blind, placebo
controlled trial conceived by Professor Robert West at University College London and
funded by the U.K. National Prevention Research Initiative. The
CASCAID trial was a 1,310 patient, single-blind, non-inferiority
trial comparing cytisine to nicotine replacement therapy (NRT). The
CASCAID trial was conceived by Dr. Natalie
Walker, National Institute for Health Innovation, University
of Auckland and funded by the
Health Research Council of New
Zealand.
Both trials were published in the New England Journal of
Medicine in December 2011 and
December 2014,
respectively.
Achieve announced in January 2017
that it had entered into a definitive merger agreement with
OncoGenex Pharmaceuticals, Inc.
References:
1.
https://www.surgeongeneral.gov/library/reports/50-years-of-progress/exec-summary.pdf
About Achieve and Cytisine
Achieve is developing
cytisine as a smoking cessation aid. Cytisine is a plant-based
alkaloid with a high binding affinity to the nicotinic
acetylcholine receptor. It is an established smoking cessation
treatment that has been approved and marketed in Central and
Eastern Europe for more than 15
years. It is estimated that over 20 million people have used
cytisine to help combat nicotine addiction, including approximately
2,000 patients in clinical trials conducted in Europe and New
Zealand. Achieve's focus is to address the global smoking
health epidemic, which is currently the leading cause of
preventable death and is responsible for nearly six million people
losing their lives annually worldwide. Discussions have been held
with FDA and a European regulatory agency to determine the clinical
and regulatory pathway towards making cytisine widely
available.
Important Additional Information about the Proposed
Merger
This communication is being made in respect of the
proposed merger involving OncoGenex Pharmaceuticals,
Inc. and Achieve Life Science, Inc. OncoGenex
intends to file a registration statement on Form S-4 with
the SEC, which will contain a joint proxy statement/prospectus
and other relevant materials, and plans to file with
the SEC other documents regarding the proposed
transaction. The final joint proxy statement/prospectus will be
sent to the stockholders of OncoGenex and Achieve. The joint proxy
statement/prospectus will contain information about OncoGenex,
Achieve, the proposed merger and related matters. STOCKHOLDERS
ARE URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS (INCLUDING
ANY AMENDMENTS OR SUPPLEMENTS) AND OTHER DOCUMENTS FILED WITH THE
SEC CAREFULLY IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE, AS THEY
WILL CONTAIN IMPORTANT INFORMATION THAT STOCKHOLDERS SHOULD
CONSIDER BEFORE MAKING A DECISION ABOUT THE MERGER AND RELATED
MATTERS. In addition to receiving the joint proxy
statement/prospectus and proxy card by mail, stockholders will also
be able to obtain the joint proxy statement/prospectus, as well as
other filings containing information about OncoGenex, without
charge, from the SEC's website (http://www.sec.gov) or,
without charge, by directing a written request
to: OncoGenex Pharmaceuticals, Inc., 19820 North
Creek Parkway, Suite 201, Bothell, WA 98011, Attention: Investor
Relations or to Achieve Life Science, Inc., 30 Sunnyside
Avenue, Mill Valley, CA 94941, Attention: Rick
Stewart.
This communication shall not constitute an offer to sell or the
solicitation of an offer to sell or the solicitation of an offer to
buy any securities, nor shall there be any sale of securities in
any jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. No offering of securities
in connection with the proposed merger shall be made except by
means of a prospectus meeting the requirements of Section 10
of the Securities Act of 1933, as amended.
Participants in Solicitation
OncoGenex and its
executive officers and directors may be deemed to be participants
in the solicitation of proxies from OncoGenex's stockholders with
respect to the matters relating to the proposed merger. Achieve and
its officers and directors may also be deemed a participant in such
solicitation. Information regarding OncoGenex's executive officers
and directors is available in OncoGenex's proxy statement on
Schedule 14A, filed with the SEC on April 21, 2016.
Information regarding any interest that OncoGenex, Achieve or any
of the executive officers or directors of OncoGenex or Achieve may
have in the transaction with Achieve will be set forth in the joint
proxy statement/prospectus that OncoGenex intends to file with
the SEC in connection with its stockholder vote on
matters relating to the proposed merger. Stockholders will be able
to obtain this information by reading the joint proxy
statement/prospectus when it becomes available.
About OncoGenex
OncoGenex is a biopharmaceutical
company committed to the development and commercialization of new
therapies that address treatment resistance in cancer patients. The
company's product candidate, apatorsen (OGX-427), is designed to
inhibit production of Hsp27, disable cancer cells' defenses and
overcome treatment resistance. Hsp27 is an intracellular protein
that protects cancer cells by helping them survive, leading to
resistance and more aggressive cancer phenotypes. Both the
potential single-agent activity and synergistic activity of
apatorsen with cancer treatments may increase the overall benefit
of existing therapies and augment the durability of treatment
outcomes, which could lead to increased patient survival. More
information is available at www.OncoGenex.com and at the
company's Twitter account: https://twitter.com/OncoGenex_IR.
OncoGenex' Forward Looking Statements
This press
release contains forward-looking statements within the meaning of
the "safe harbor" provisions of the Private Securities Litigation
Reform Act of 1995, including, but not limited to, statements
regarding the proposed merger with Achieve Life Science; the
non-clinical and clinical development of cytisine, including the
timing of expected development milestones; the potential benefits
of cytisine and apatorsen; and the potential market opportunity and
size for cytisine. All statements other than statements of
historical fact are statements that could be deemed forward-looking
statements. OncoGenex and/or Achieve may not actually achieve the
proposed merger, or any plans or product development goals in a
timely manner, if at all, or otherwise carry out the intentions or
meet the expectations or projections disclosed in these
forward-looking statements. These statements are based on
management's current expectations and beliefs and are subject to a
number of risks, uncertainties and assumptions that could cause
actual results to differ materially from those described in the
forward-looking statements, including, among others, the failure of
the OncoGenex or Achieve stockholders to approve the transaction;
the failure of either party to meet the closing conditions of the
transaction; delays in completing the transaction and the risk that
the transaction may not be completed at all; the failure to realize
the anticipated benefits from the transaction or delay in
realization thereof; the success of the combined businesses;
operating costs and business disruption during the pendency of and
following the proposed merger; the risk that product candidates
will not receive regulatory approval or be successfully
commercialized; the risk that new developments in the rapidly
evolving cancer therapy landscape require changes in business
strategy or clinical development plans; the risk that product
candidates may not demonstrate the hypothesized or expected
benefits; general business and economic conditions; and the
other factors described in our risk factors set forth in
OncoGenex's filings with the Securities and Exchange
Commission from time to time, including its Annual Report on
Form 10-K and Quarterly Reports on Form 10-Q. OncoGenex undertakes
no obligation to update the forward-looking statements contained
herein or to reflect events or circumstances occurring after the
date hereof, other than as may be required by applicable law.
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SOURCE OncoGenex Pharmaceuticals, Inc.