Grant awarded to Dr. Jacek Pinski
to conduct the study at the Norris Comprehensive Cancer Center of
the University of Southern
California
QUÉBEC CITY, Aug. 5
/PRNewswire-FirstCall/ - Aeterna Zentaris Inc. (TSX: AEZ; Nasdaq:
AEZS), (the "Company"), a late-stage drug development company
specialized in oncology and endocrine therapy, today announced that
the National Institutes of Health ("NIH") has awarded Dr.
Jacek Pinski, Associate Professor of
Medicine at the Norris Comprehensive Cancer Center of the
University of Southern California, a
grant of about US$1.5 million over
three years to conduct a Phase 1/2 study in refractory prostate
cancer with the Company's doxorubicin LHRH receptor targeted
conjugate compound, AEZS-108. The study, entitled "A Phase I/II
Trial of AN-152 (AEZS-108) in Castration- and Taxane-Resistant
Prostate Cancer", will enroll up to 55 patients and will be
conducted in two portions: the first portion will be an abbreviated
dose-escalation followed by a single arm, Simon Optimum two-stage
design Phase 2 study using the dose selected in the Phase 1
portion. The primary objective of the Phase 2 portion is to
evaluate the clinical benefit of AEZS-108 in men with castration-
and taxane-resistant metastatic prostate cancer, for which the
presence of LHRH receptors has been confirmed.
Juergen Engel, Ph.D., President
and CEO of Aeterna Zentaris commented, "We congratulate Dr. Pinski
for the grant awarded by the NIH and we are very pleased to
initiate this collaboration for AEZS-108. We are excited about this
study since we believe AEZS-108, with its targeting approach, could
represent an achievement in treating men with castration- and
taxane-resistant prostate cancer, especially for those having
LHRH-receptor-positive cells."
Jacek Pinski, MD, Associate
Professor of Medicine at the Norris Comprehensive Cancer Center of
the University of Southern California
stated, "We are looking forward to working with Aeterna Zentaris
which developed AEZS-108 in collaboration with the Nobel Laureate
Dr. Andrew V. Schally, from the
University of Miami and VA Medical
Center in Miami. Given the
positive results presented for LHRH-receptor-positive cells in
prostate cancer at ASCO 2009, the positive results demonstrated for
ovarian cancer at ASCO 2010 and the targeting action of AEZS-108 to
be delivered specifically to the cancer cells, we hope to avoid
damage to healthy tissue and to reduce side effects, since prostate
cancer patients often have other medical conditions."
In previous research, Dr. Pinski found that cancerous cells in
human prostate tissue contain the luteinizing hormone-releasing
hormone (LHRH) receptor (ASCO 2009, abstract #5163), the cellular
receptor specifically targeted by AEZS-108.
In addition to performing this Phase 1/2 trial, Dr. Pinski will
also lead a team that uses new methods for collecting circulating
tumor cells and analyzing data about AEZS-108's effectiveness in
advanced prostate cancer.
About AEZS-108
AEZS-108 (formerly known as AN-152) represents a new targeting
concept in oncology using a cytotoxic peptide conjugate which is a
hybrid molecule composed of a synthetic peptide carrier and a
well-known cytotoxic agent, doxorubicin. The design of this product
allows for the specific binding and selective uptake of the
cytotoxic conjugate by LHRH-receptor-positive tumors. The binding
of AEZS-108 to cancerous cells that express these receptors results
in its accumulation and preferential uptake in the malignant
tissue. AEZS-108 has already been studied in gynecologic cancers
and has been shown to be effective and well tolerated in
endometrial and ovarian cancer. Preclinical studies in animal
models with prostate cancer also have demonstrated positive results
with the drug.
AEZS-108 is currently in a Phase 2 trial conducted in
Europe by the German AGO Study
Group (Study AGO-GYN5), in advanced ovarian and endometrial cancer.
Positive final Phase 2 results for ovarian cancer were disclosed in
June 2010 at the annual American
Society of Clinical Oncology ("ASCO") meeting, while those for
endometrial cancer are expected by year-end. AEZS-108 has been
granted orphan-drug designation by the FDA and has received a
positive opinion for Orphan Medicinal Product designation from the
Committee for Orphan Medicinal Products (COMP) of the European
Medicines Agency, for the treatment of ovarian cancer.
About Prostate Cancer
According to the National Cancer Institute (NCI), prostate
cancer is the second most prevalent type of cancer after lung
cancer. The NCI estimates that 217,730 men will be diagnosed with
and 32,050 men will die of prostate cancer in 2010 in the United States alone.
About Aeterna Zentaris Inc.
Aeterna Zentaris Inc. is a late-stage drug development company
specialized in oncology and endocrine therapy. News releases and
additional information are available at www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made
pursuant to the safe harbor provisions of the U.S. Securities
Litigation Reform Act of 1995. Forward-looking statements involve
known and unknown risks and uncertainties, which 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 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
the 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
except if we are required by a governmental authority or applicable
law.
SOURCE AETERNA ZENTARIS INC.
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