QUÉBEC CITY, June 3, 2013 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ:
AEZS) (TSX: AEZ) (the "Company") today announced that final data for
the Phase 1 portion of the ongoing Phase 1/2 trial with its lead
oncology compound, zoptarelin doxorubicin (AEZS-108), demonstrated the
compound's promising anti-tumor activity in heavily pre-treated men
with castration- and taxane-resistant prostate cancer. Results were
presented earlier today by lead investigator, Jacek Pinski, MD, PhD, of
the USC Norris Comprehensive Cancer Center, during a poster session at
the American Society of Clinical Oncology's ("ASCO") Annual Meeting in
David Dodd, President and CEO of Aeterna Zentaris stated, "We are
encouraged with the Phase 1 portion data and look forward to further
results from the current Phase 2 portion of this investigator-driven
trial. Because luteinizing hormone-releasing hormone receptors are
expressed in a great number of prostate cancers, we believe that
zoptarelin doxorubicin (AEZS-108), which specifically targets those
receptors, may represent a novel targeted treatment for men with this
disease. Expansion into prostate, breast and bladder cancer with
zoptarelin doxorubicin (AEZS-108) after positive Phase 2 results in
endometrial and ovarian cancer, is further demonstration of the
potential of this innovative compound in a variety of cancer
indications for both men and women."
This was a dose-escalation Phase 1 trial in men with castration- and
taxane-resistant prostate cancer to confirm the dose established in a
Phase 1 trial in women. Patients received zoptarelin doxorubicin
(AEZS-108) every 21 days until progression or unacceptable toxicity.
The primary endpoint was safety. Circulating Tumor Cells ("CTC") were
captured with a novel slot microfilter and identified by PSA and DAPI
staining. AEZS-108 internalization was visualized by fluorescence
Eighteen men with a median of 2 prior chemotherapy regimens (range 1-5)
and a median PSA of 106.4 ng/mL (range 8.4-1624.0) were enrolled. The
dose of zoptarelin doxorubicin (AEZS-108) was escalated from 160 mg/m2 to 210 mg/m2 then to 267 mg/m2. There were 2 Dose-Limiting Toxicities ("DLT") in the 7 patients
receiving zoptarelin doxorubicin (AEZS-108) at a dose of 267 mg/m2 (grade 4 neutropenia and grade 3 febrile neutropenia), prompting
de-escalation to 210 mg/m2, where 1 of 8 patients experienced a DLT (grade 4 neutropenia),
establishing 210 mg/m2 as the Maximum Tolerated Dose ("MTD"). Significant non-hematologic
toxicities included one case of grade 3 nausea. No cardiotoxicity was
seen on serial evaluation and 6 patients completed 6 cycles.
Internalization of zoptarelin doxorubicin (AEZS-108) was consistently
visualized in CTCs 1 to 3 hours after dosing. Maximal PSA response was
stable or decreased in 8 of 18 men.
In general, zoptarelin doxorubicin (AEZS-108) was well tolerated and
demonstrated promising evidence of its anti-tumor activity in this
heavily pretreated population with castration- and taxane-resistant
prostate cancer. Among the 15 evaluable patients with measurable
disease, 10 achieved stable disease and a drop in PSA was noted in 3
patients. The MTD of zoptarelin doxorubicin (AEZS-108) in this
indication is 210 mg/m2, which is below the MTD reported in women with refractory endometrial
and ovarian cancer.
The poster entitled, "A Phase I Dose-Escalation Trial of AEZS-108 in Castration- and
Taxane-Resistant Prostate Cancer", is available on ASCO's website at the following link.
Current Phase 2 Portion of the Study
This is a single-arm Simon Optimum design Phase 2 study of zoptarelin
doxorubicin (AEZS-108) involving up to 37 patients with pre-treated
castration-and taxane-resistant prostate cancer, using the dose
selected (210 mg/m2) in the Phase 1 portion. The primary endpoint is to evaluate the
clinical benefit of zoptarelin doxorubicin (AEZS-108) for these
patients. Clinical benefit will be defined as non-progression at 12
weeks with no dose-limiting toxicity or other toxicity requiring
termination of treatment.
More information on the current Phase 2 portion of the trial is
available at this link NCT01240629.
About zoptarelin doxorubicin (AEZS-108)
Zoptarelin doxorubicin (AEZS-108) 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 (AEZS-108) is the first intravenous drug in advanced
clinical development that directs the chemotherapy agent specifically
to Luteinizing Hormone-Releasing Hormone ("LHRH")-receptor expressing
tumors, resulting in more targeted treatment with less damage to
healthy tissue. The product has successfully completed Phase 2 studies
for the treatment of ovarian and endometrial cancer and the Company is
currently initiating a Phase 3 trial in endometrial cancer under a
Special Protocol Assessment. Zoptarelin doxorubicin (AEZS-108) is also
in Phase 2 trials in triple-negative breast cancer, prostate cancer and
bladder cancer. Zoptarelin doxorubicin (AEZS-108) has been granted
orphan drug designation by the FDA and orphan medicinal product
designation from the European Medicines Agency for the treatment of
ovarian cancer. Aeterna Zentaris owns worldwide rights to zoptarelin
About Aeterna Zentaris
Aeterna Zentaris is an oncology and endocrinology drug development
company currently investigating treatments for various unmet medical
needs. The Company's pipeline encompasses compounds at all stages of
development, from drug discovery through to marketed products. For more
information, visit www.aezsinc.com.
This press release contains forward-looking statements made pursuant to
the safe harbour provisions of the U.S. 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, 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 take advantage of business opportunities in
the pharmaceutical industry, uncertainties related to the regulatory
process and general changes in economic conditions.
Investors should consult the Company's quarterly and annual filings with
the Canadian and U.S. securities commissions for additional information
on risks and uncertainties relating to forward-looking statements.
Investors are cautioned not to rely 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.