Aeterna Zentaris Announces Top-Line Results of Confirmatory Phase 3 Trial of Macrilen™
January 04 2017 - 5:15PM
Business Wire
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the “Company”)
today announced that the confirmatory Phase 3 clinical trial of
Macrilen™ (macimorelin) failed to achieve its objective of
validating a single oral dose of macimorelin for the evaluation of
growth hormone deficiency in adults (“AGHD”), using the insulin
tolerance test (the “ITT”) as a comparator. The Company is
evaluating the outcome of the trial and will determine in the near
future whether it will continue with the development of
Macrilen™.
Dr. Richard Sachse, the Company’s Chief Scientific Officer,
stated, “We are, of course, very disappointed about the outcome of
the trial. Based on an analysis of top-line data, macimorelin did
not achieve equivalence to the ITT as a means of diagnosing AGHD.
Under the study protocol, the evaluation of AGHD with Macrilen™
would be considered successful, if the lower bound of the two-sided
95% confidence interval for the primary efficacy variables was 75%
or higher for “percent negative agreement” with the ITT, and 70% or
higher for the “percent positive agreement” with the ITT. While the
estimated percent negative agreement met the success criteria, the
estimated percent positive agreement did not reach the criteria for
a successful outcome. Therefore, the results did not meet the
pre-defined equivalence criteria which required success for both
the percent negative agreement and the percent positive agreement.
After a thorough internal review and understanding of this data,
the Company will decide upon the appropriate future course of
action with respect to macimorelin.”
David A. Dodd, the President and Chief Executive Officer of the
Company, stated, “While we are disappointed regarding the outcome
of this trial, we will now re-direct our resources to the
completion of the on-going Phase 3 clinical trial of Zoptrex™ in
women with advanced, recurrent or metastatic endometrial cancer who
have progressed and who have received one chemotherapeutic regimen
with platinum and taxane (either as adjuvant or first-line
treatment). Zoptrex™ represents a new targeting concept in oncology
using a hybrid molecule composed of a synthetic peptide carrier and
a well-known chemotherapy agent, doxorubicin. It is the first drug
in advanced clinical development that is considered to direct the
chemotherapy agent specifically to LHRH-receptor expressing tumors,
which then could result in a targeted treatment with less damage to
healthy tissue. Potential benefits of this targeted approach
include better efficacy and a more favorable safety profile with
lower incidence and severity of side effects as compared to
doxorubicin alone. We look forward to reporting the results of this
trial in the very near future.”
Conference Call
The Company will host a conference call to discuss the results
of the confirmatory Phase 3 clinical study of Macrilen™ on
Thursday, January 5, 2017, at 8:30AM, Eastern Time. Participants
may access the conference call by using the following
number: 201-689-8029, Confirmation 13651438.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty biopharmaceutical company
engaged in developing and commercializing Zoptrex™, a novel
cytotoxic compound. We intend to license out certain commercial
rights to Zoptrex™ to licensees in territories where such
out-licensing would enable us to ensure development, registration
and launch of the product. Our goal is to become a growth-oriented
specialty biopharmaceutical company by pursuing successful
development and commercialization of our product portfolio,
achieving successful commercial presence and growth, while
consistently delivering value to our shareholders, employees and
the medical providers and patients who will benefit from our
products. For more information, visit www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made
pursuant to the safe harbor provisions of the US Securities
Litigation Reform Act of 1995. Forward-looking statements may
include, but are not limited to statements preceded by, followed
by, or that include the words “expects,” “believes,” “intends,”
“anticipates,” and similar terms that relate to future events,
performance, or our results. Forward-looking statements involve
known and unknown risks and uncertainties that could cause the
Company’s actual results to differ materially from those in the
forward-looking statements. Such risks and uncertainties include,
among others, the availability of funds and resources to pursue
R&D projects and clinical trials, the successful and timely
completion of clinical studies, the risk that safety and efficacy
data from any of our Phase 3 trials may not coincide with the data
analyses from previously reported Phase 1 and/or Phase 2 clinical
trials, the rejection or non-acceptance of any new drug application
by one or more regulatory authorities and, more generally,
uncertainties related to the regulatory process, the ability of the
Company to efficiently commercialize one or more of its products or
product candidates, the degree of market acceptance once our
products are approved for commercialization, the ability of the
Company to take advantage of business opportunities in the
pharmaceutical industry, the ability to protect our intellectual
property, the potential of liability arising from shareholder
lawsuits and general changes in economic conditions. Investors
should consult the Company's quarterly and annual filings with the
Canadian and US securities commissions for additional information
on risks and uncertainties relating to forward-looking statements.
Investors are cautioned not to place undue reliance on these
forward-looking statements. The Company does not undertake to
update these forward-looking statements. We disclaim any obligation
to update any such factors or to publicly announce the result of
any revisions to any of the forward-looking statements contained
herein to reflect future results, events or developments, except if
required to do so.
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Aeterna Zentaris Inc.Philip A. Theodore, 843-900-3223Senior Vice
Presidentir@aezsinc.com
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