Aeterna Zentaris Announces Zoptrex™ Presentation in Prostate Cancer at 2017 Genitourinary Cancers Symposium
February 14 2017 - 5:30PM
Business Wire
Aeterna Zentaris Inc. (NASDAQ: AEZS)(TSX: AEZ) (the “Company”)
today announced that a poster entitled, “A phase II trial of
zoptarelin doxorubicin in castration-and taxane-resistant prostate
cancer”, will be presented during the 2017 Genitourinary Cancers
Symposium’s “Translating Research to Value-based and
Patient-centric Care” by lead investigator, and co-author of the
presentation, Jacek Pinski, MD, PhD, USC Norris Comprehensive
Cancer Center, in Orlando, Florida on Thursday, February 16,
2017 at 11:30am-1:00pm ET and 5:15pm-6:15pm ET. The event is a
co-sponsored by the American Society of Clinical Oncology – ASCO;
Society of Urologic Oncology – SUO; and Targeting Cancer Care –
ASTRO. The address for the sessions is Rosen Shingle Creek Hotel,
9939 Universal Blvd, Orlando, FL 32819.
Background
On December 14, 2010, the Company announced the initiation of
the Phase 1/2 trial.
On February 3, 2012, updated results for the Phase 1 portion of
the study were reported. The results were based on 13 patients who
had been previously treated with androgen-deprivation therapy (LHRH
agonist) and at least one taxane-based chemotherapy regimen, who
were treated on three dose levels of Zoptrex™: three at 160 mg/m2,
three at 210 mg/m2, and seven at 267 mg/m2. Overall, Zoptrex™ was
well tolerated among this group of heavily pretreated older
patients. There were two dose-limiting toxicities, each of which
having been a case of asymptomatic Grade 4 neutropenia at the 267
mg/m2 dose level and both patients fully recovered. The Grade 3 and
4 toxicities were primarily hematologic. There was minimal non-
hematologic toxicity, most frequently fatigue and alopecia. Despite
the low doses of Zoptrex™ in the first cohorts, there was
indication of antitumor activity. One patient received eight cycles
(at 210 mg/m2) due to continued benefit. Among the five evaluable
patients with measurable disease, four achieved stable disease. At
the time of submission of the abstract, a decrease in prostate
specific antigen (“PSA”) was noted in six patients. Six of 13 (46%)
treated patients received at least five cycles of therapy with no
evidence of disease progression at twelve weeks.
On November 12, 2012, we announced the initiation of the Phase 2
portion of Dr. Pinski’s Phase 1/2 study of Zoptrex™ in prostate
cancer. This was a single-arm Simon Optimum Design Phase 2 study of
Zoptrex™ in 25 patients with castrate-resistant prostate cancer
(CRPC). Patients received Zoptrex™ (210 mg/m2) intravenously over
two hours, every three weeks. The primary endpoint was clinical
benefit (“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).
On June 3, 2013, we announced that final data for the Phase 1
portion of Dr. Pinski’s Phase 1/2 trial with Zoptrex™ in prostate
cancer demonstrated the compound's promising anti-tumor activity.
Results were presented by Dr. Pinski during a poster session at the
ASCO Annual Meeting in Chicago. The results of the study were
published in an article by Liu et al in the journal Clinical Cancer
Research (Clin. Cancer Res. (2014) 20:6277). Eighteen men were
treated at three dose levels: (160 mg/m2; (ii) 210 mg/m2; and (iii)
267 mg/m2). Overall Zoptrex™ was well tolerated among this group of
heavily pretreated patients. There were two dose-limiting
toxicities (grade four neutropenia and grade three febrile
neutropenia), prompting de- escalation to 210 mg/m2 and
establishing it as the Maximum Tolerated Dose. Among the 15
evaluable patients with measurable disease, ten achieved stable
disease (SD), and a drop in PSA was noted in three patients.
On September 28, 2015, Dr. Pinski announced during a poster
session at the 18th ECCO - 40th ESMO European Cancer Congress in
Vienna, Austria, that among the 25 patients in the Phase 2 portion
of the trial, 11 patients experienced CB as the primary endpoint
and 13 patients achieved SD. Maximal PSA response was stable in 20
patients. Pain assessment improved for 11 patients. Zoptrex™ was
well tolerated in this heavily pretreated patient population with
hematological toxicities, usually limited to grade three, as the
most common adverse events. Dr. Pinski concluded that Zoptrex™ was
well tolerated and met the primary efficacy endpoint in castration-
and taxane-resistant prostate cancer patients.
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, resulting in a
more targeted treatment with less damage to healthy tissue. The
Company recently concluded a Phase 3 trial in women with advanced,
recurrent or metastatic endometrial cancer called ZoptEC
(Zoptarelin doxorubicin in Endometrial Cancer). Aeterna Zentaris
owns the worldwide rights to this compound.
Additional Indications
The Company believes that Zoptrex™ may be useful in treating
other cancers, including breast cancer, bladder cancer and prostate
cancer. We terminated early clinical trials of the compound as a
treatment for triple-negative breast cancer and bladder cancer as
part of our ongoing review of our development activities to ensure
the most effective use of our resources.
The Company assisted Dr. Jacek Pinski, Associate Professor of
Medicine at the Norris Comprehensive Cancer Center of the
University of Southern California, to conduct a Phase 1/2 study in
refractory prostate cancer with Zoptrex™. Dr. Pinski received a
$1.6 million grant from The National Institutes of Health (“NIH”)
to conduct the study. The study, entitled “A Phase I/II Trial of
AN-152 [AEZS-108] in Castration-and Taxane-Resistant Prostate
Cancer,” was conducted in two portions: an abbreviated
dose-escalation study followed by a single arm, Simon Optimum
two-stage design Phase 2 study, using the dose selected in the
Phase 1 portion.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty biopharmaceutical company
engaged in developing and commercializing novel treatments in
oncology, endocrinology and women’s health. We are engaged in drug
development activities and in the promotion of products for others.
We recently completed Phase 3 studies of two internally developed
compounds. The focus of our business development efforts is the
acquisition of licenses to products that are relevant to our
therapeutic areas of focus. We also intend to license out certain
commercial rights of internally developed products to licensees in
non-US territories where such out-licensing would enable us to
ensure development, registration and launch of our product
candidates. 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170214006123/en/
Aeterna Zentaris Inc.Philip A. Theodore, Senior Vice President,
843-900-3223IR@aezsinc.com
Aeterna Zentaris (NASDAQ:AEZS)
Historical Stock Chart
From Aug 2024 to Sep 2024
Aeterna Zentaris (NASDAQ:AEZS)
Historical Stock Chart
From Sep 2023 to Sep 2024