AEterna Zentaris Reports Encouraging Results from Phase I Trial of Perifosine in Combination with Radiotherapy at the 2004 Ameri
June 07 2004 - 10:21AM
PR Newswire (US)
AEterna Zentaris Reports Encouraging Results from Phase I Trial of
Perifosine in Combination with Radiotherapy at the 2004 American
Society of Clinical Oncology (ASCO) Annual Meeting Data
demonstrated acceptable safety/tolerability and preliminary
evidence of antitumor activity, including multiple complete and
partial responses, at all dosage levels. NEW ORLEANS, Louisiana,
June 7 /PRNewswire-FirstCall/ -- AEterna Zentaris Inc. (TSX: AEZ;
NASDAQ: AEZS) announced today encouraging final results from
recently completed Phase I trial evaluating perifosine, the
Company's novel, first-in- class, oral AKT inhibitor, in
combination with radiotherapy in patients with unresectable locally
advanced tumors, in a poster session at the 2004 ASCO Annual
Meeting, which takes place in New Orleans, LA. Marcel Verheij,
M.D., of the Netherlands Cancer Institute, presented poster No. N3-
3064 entitled "Phase I Study of Combined Treatment with the Oral
Alkyl- Lysophospholipid (ALP) Perifosine and Radiation in Patients
with Advanced Solid Tumors." A total of 21 radiotherapy-naive
patients, of whom 17 had advanced non- small cell lung cancer (1
Stage IIIA, 15 Stage IIIB, 1 Stage IV) and 14 had become refractory
to prior chemotherapy, received oral perifosine doses ranging from
50 mg to 200 mg/day concurrently with standard doses of
radiotherapy. The trial data demonstrated the following: (i)
acceptable safety and tolerability, with 150 mg/day established as
the dose recommended for use in subsequent clinical trials; (ii)
dose limiting toxicity (nausea/vomiting) at 200 mg/day; (iii) no
bone marrow toxicity; and (iv) preliminary evidence of antitumor
activity at all dosage levels, including complete or partial
responses (complete disappearance and decreased tumor size,
respectively), or stable disease, with a median follow-up for
responders of 8 months (see Phase I trial data summary table at the
end of the press release). Importantly, in the cohort of 10
patients who were treated with 150 mg/day established as the dose
recommended for use in subsequent clinical trials, there were 3
complete responses (2 non-small cell lung cancer (NSCLC) and 1
esophageal cancer), 3 partial responses (2 NSCLC and 1 prostate
cancer), and 4 patients with stable disease. In addition, a patient
with bladder cancer who received 50 mg/day perifosine had an
unexpected finding, namely a long- lasting complete response. These
Phase I results support the ongoing clinical development of
perifosine and will form the basis for subsequent
placebo-controlled trials evaluating perifosine in combination with
radiotherapy as a potential treatment for multiple types of cancer.
Based on perifosine's pharmacokinetic profile (plasma concentration
fluctuations), in future trials, perifosine will be administered 1
week prior to radiotherapy. AEterna Zentaris plans to initiate
Phase II trials on perifosine in combination with radiotherapy
through the ongoing collaboration with the Netherlands Cancer
Institute of Amsterdam. The ongoing clinical development of
perifosine in North America includes nine open-label, single agent
Phase II trials in six cancer types that are being conducted
through collaboration with Keryx Biopharmaceuticals Inc.
(NASDAQ:KERX) and the United States National Cancer Institute
(NCI). AEterna Zentaris holds ex-North America rights to perifosine
through Zentaris GmbH, which originally discovered and developed
perifosine. To date, five Phase I trials have been conducted on
perifosine, including the trial highlighted at ASCO. In the four
preceding trials, use of perifosine as a single agent in a total of
94 patients provided initial, encouraging evidence of antitumor
activity. Namely, investigators observed two partial responses (
greater than 50% reduction) in patients with sarcoma and sixteen
stable disease in patients with breast, prostate, pancreatic and
other forms of cancer. About AEterna Zentaris Inc. AEterna Zentaris
Inc. is a biopharmaceutical company focused in oncology and
endocrine therapy. Its extensive portfolio, from drug discovery to
marketed products, includes perifosine, an orally-active AKT
inhibitor in several Phase II trials for multiple cancers, and
cetrorelix, an LHRH antagonist already marketed for in vitro
fertilization under the brand name Cetrotide(R), and also in
advanced clinical development for the treatment of uterine myoma,
endometriosis and benign prostatic hyperplasia (BPH). AEterna
Zentaris owns 100% of Zentaris GmbH in Germany. It also owns 62% of
Atrium Biotechnologies Inc., which develops, distributes and
markets active ingredients, specialty fine chemicals, cosmetic and
nutritional products for the cosmetics, chemical, pharmaceutical
and nutritional industries. News releases and additional
information about AEterna Zentaris are available on its new Web
site http://www.aeternazentaris.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. > DATASOURCE:
AETERNA ZENTARIS INC. CONTACT: Media Relations, Paul Burroughs,
(418) 652-8525 ext. 406, ; Investor Relations, Jacques Raymond,
(418) 652-8525 ext. 360, ; U.S. Investor Relations,
Lippert/Heilshorn & Associates, Kim Golodetz, (212) 838-3777, ;
Europe, Matthias Seeber, +49 69 42602 3425,
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