QUEBEC CITY, Sept. 28, 2015 /PRNewswire/ - Aeterna Zentaris
Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today
announced that its lead oncology compound, zoptarelin doxorubicin
(formerly AEZS‑108), met the primary end-point of the
investigator-driven and sponsored Phase 2 clinical trial in
Castration and taxane Resistant Prostate Cancer (CRPC) and
demonstrated good tolerability. The primary endpoint was Clinical
Benefit (CB) defined as remaining progression-free by RECIST and
Prostate Specific Antigen (PSA) after treatment for 12+ weeks.
Results were presented this morning by lead investigator,
Jacek Pinski, MD, PhD, of the
USC Norris Comprehensive Cancer Center,
during a poster session at the 18th ECCO –
40th ESMO European Cancer Congress in Vienna, Austria.
David A. Dodd, Chairman and CEO
of Aeterna Zentaris, commented, "We are encouraged with the Phase 2
results for zoptarelin doxorubicin in prostate cancer. Because
luteinizing hormone-releasing hormone receptors are expressed in a
great number of cancers including prostate cancer, we believe that
zoptarelin doxorubicin, which specifically targets those receptors,
may represent a novel targeted treatment for men with this disease.
These Phase 2 results in prostate cancer, as well as prior positive
Phase 2 results in endometrial and ovarian cancer, are further
demonstration of the potential of this innovative compound in a
variety of cancer indications for both men and women."
Study Design
This was a single-arm Simon Optimum design Phase 2 study of
zoptarelin doxorubicin in 25 patients with CRPC. Patients received
zoptarelin doxorubicin (210 mg/m2) intravenously over 2
hours, every 3 weeks. The primary endpoint was CB, defined as
remaining progression-free by RECIST and PSA after treatment for
12+ weeks. Secondary endpoints were progression free survival
(PFS), best overall response, toxicity, pain and overall survival
(OS).
Results
Twenty patients had measurable disease, with a median of 1 prior
chemotherapy regimens and a median PSA of 255.8 ng/ml. Eleven
patients experienced CB; 13 patients achieved stable disease.
Median PFS and OS were 4.4 months (95% CI: 3.6, 5.5) and 6 months
(95% CI: 4.2, 10.7) respectively. Forty-four percent of patients
demonstrated improvement of pain score at 12 weeks. Maximal PSA
response was stable in 20 patients. Zoptarelin doxorubicin
demonstrated good tolerability with grade 3‑4 hematologic (n=7) and
grade 3 blood and lymphatic system disorders (n=5) adverse events
as the most common events.
Titled, "A Phase 2 Trial of AEZS-108 in Castration- and
Taxane-Resistant Prostate Cancer", Liu SV, Tsao‑Wei DD, Xiong
S, Groshen S, Dorff TB, Quinn DI, Tai YC, Engel J, Hawes D, Schally
AV, Pinski J, the poster is available at this link.
About Zoptarelin Doxorubicin
Zoptarelin doxorubicin represents a new targeting concept in
oncology using a hybrid molecule composed of a synthetic peptide
carrier and a well-known chemotherapy agent, doxorubicin.
Zoptarelin doxorubicin is the first intravenous drug in advanced
clinical development that directs the chemotherapy agent
specifically to LHRH-receptor expressing tumors, which could result
in a more targeted treatment with less damage to healthy tissue.
The Company is currently conducting a fully-enrolled ZoptEC
(Zoptarelin doxorubicin in Endometrial Cancer)
Phase 3 trial in women with advanced, recurrent or metastatic
endometrial cancer; results from a second interim analysis of this
trial are expected in October 2015.
Zoptarelin doxorubicin is also in an investigator‑initiated Phase 2
trial in prostate cancer. Aeterna Zentaris owns the worldwide
rights to this compound except in China (including Hong Kong and Macau) where rights have been
out-licensed to Sinopharm A-Think Pharmaceuticals, a subsidiary of
Sinopharm, the largest medical and healthcare group in China and on Fortune's Global 500 list. On
April 16, 2015, the Company announced
the filing of a patent application intended to strengthen the
exclusivity of zoptarelin doxorubicin through a unique,
significantly lower cost in the manufacturing process.
About Prostate Cancer
According to the American Cancer Society, prostate cancer is the
second most common cancer in men worldwide, affecting approximately
one in six males. It is estimated that there will be approximately
220,800 new cases of prostate cancer in the United States in 2015. While prostate
cancer is prevalent among men of all ages and races, African
Americans and men older than 65 have a higher rate of
diagnosis.
About Aeterna Zentaris
Aeterna Zentaris is a specialty biopharmaceutical company
engaged in developing and commercializing novel treatments in
oncology, endocrinology and women's health. 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 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 ability of the Company to efficiently commercialize one
or more of its products or product candidates, the ability of the
Company to take advantage of business opportunities in the
pharmaceutical industry, uncertainties related to the regulatory
process, 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, unless required
to do so by a governmental authority or by applicable law.
SOURCE Aeterna Zentaris Inc.