QUEBEC CITY, April 7 /PRNewswire-FirstCall/ -- AEterna Laboratories Inc. (TSX: AEL; Nasdaq: AELA) along with its wholly-owned subsidiary Zentaris GmbH, announced today that results of the 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 will be presented at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting. The meeting will take place in New Orleans, LA, June 5 through 8, 2004. The lead investigator for the trial, Dr. Marcel Verheij, from the Department of Radiation of the Netherlands Cancer Institute of Amsterdam, will present the results.
The Phase I results to be presented at ASCO will form the basis for a Phase II trial evaluating Perifosine in combination with radiotherapy in patients selected for specific tumor types. Zentaris plans to evaluate Perifosine in combination with radiotherapy as a treatment for multiple types of cancer through the ongoing collaboration with the Netherlands Cancer Institute of Amsterdam.
The ongoing clinical development of Perifosine in North America includes nine Phase II trials in six cancer types that are being conducted through collaboration between Zentaris GmbH, Keryx Biopharmaceuticals Inc. and the United States National Cancer Institute (NCI). AEterna, through Zentaris GmbH, holds ex-North America rights to Perifosine. To date, five Phase I trials have been conducted on Perifosine, including the trial to be 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 anti-tumor 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.
Initial data from the Phase I trial undertaken by Dr. Verheij to evaluate the safety and tolerability, as well as to determine the maximum tolerated dose of Perifosine in the combination therapy regimen were reported in 2003 at the Second International Conference on Translational Research and Preclinical Strategies in Radiation Oncology (Lugano, Switzerland). Initial data in 7 patients with non-small cell lung cancer (NSCLC) and bladder cancer, who received Perifosine doses ranging from 50 to 100 mg/day concurrently with standard doses of radiotherapy, demonstrated acceptable tolerability. In addition, the combination regimen was not associated with bone marrow toxicity, an often treatment-limiting side effect associated with many cancer therapies currently on the market. The trial was continued with the goal to define the highest dose of Perifosine that is well tolerated in the combination regimen.
About AEterna Laboratories
AEterna Laboratories Inc. along with its wholly-owned subsidiary Zentaris GmbH, is a biopharmaceutical company with an extensive product portfolio, including two marketed products and 14 other product candidates under development in oncology, endocrinology and infectious diseases. Cetrorelix (Cetrotide(R)) is sold in the U.S., Europe and several other countries to the in vitro fertilization market, and is in Phase II clinical trials for endometriosis, uterus myoma and enlarged prostate (BPH). Miltefosine (Impavido(R)) is sold for black fever and has successfully completed a Phase III trial in parasitic skin disease. Neovastat(R) is in a Phase III trial for non-small cell lung cancer. Perifosine, the first orally-active AKT inhibitor, is in Phase II trials for multiple cancers. Several other clinical programs are underway with various potential development candidates, supported by a worldwide network of scientific and marketing partnerships. Furthermore, AEterna benefits from a discovery platform of 100,000 molecules, which is generating promising new compounds.
AEterna also owns 62% of its subsidiary Atrium Biotechnologies Inc. which develops and markets active ingredients and speciality fine chemicals in the health and personal care industry for the cosmetics, chemical, pharmaceutical and nutritional industries. Its international business network and portfolio of over 1,000 products sold to over 2,000 institutional customers and to over 36,000 physicians and other health care professionals, have generated significant growth in sales and earnings since the Company was founded in January 2000. In 2003, Atrium sales exceeded $120 million.
AEterna shares are listed on the Toronto Stock Exchange (AEL) and the NASDAQ National Market (AELA). News releases and additional information about AEterna are available on its Web site at http://www.aeterna.com/ .
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-
AETERNA LABORATORIES INC.
CONTACT: AEterna Laboratories: Media Relations: PaulBurroughs, (418) 652-8525, ext. 406, (418) 573-8982 cell.,firstname.lastname@example.org; Investor Relations: Jacques Raymond,(418) 652-8525, ext. 360, (514) 703-5654 cell.,email@example.com; U.S. Investor Relations: Lippert | Heilshorn &Associates, Kim Golodetz, (212) 838-3777, firstname.lastname@example.org; Europe:Zentaris GmbH, Matthias Seeber, + 49 69 42 602 3425, fax: + 49 69 42 602 3444,email@example.com