FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
REPORT OF FOREIGN ISSUER
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For the month of September 2003
AETERNA LABORATORIES INC.
(Translation of registrant's name into English)
1405, boul. du Parc-Technologique
Quebec, Quebec
Canada, G1P 4P5
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form 20-F Form 40-F X
----- -----
Indicate by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of
1934
Yes No X
----- -----
If "Yes" is marked, indicate below the file number assigned to the registrant
in connection with Rule 12g3-2(b): 82-_________
DOCUMENTS INDEX
Documents Description
1. Material Change Report dated October 3rd, 2003
MATERIAL CHANGE REPORT
UNDER
SECTION 75(2) OF THE SECURITIES ACT (ONTARIO),
SECTION 81(2) OF THE SECURITIES ACT (NOVA SCOTIA),
SECTION 76(2) OF THE SECURITIES ACT (NEWFOUNDLAND AND LABRADOR),
SECTION 84(1)(b) OF THE SECURITIES ACT (SASKATCHEWAN),
SECTION 112 OF THE SECURITIES ACT (MANITOBA),
SECTION 146(1)(b) OF THE SECURITIES ACT (ALBERTA) AND
SECTION 85(1)(b) OF THE SECURITIES ACT (BRITISH COLUMBIA)
ITEM 1. REPORTING ISSUER
AEterna Laboratories ("AETERNA" or the "CORPORATION")
1405 Parc Technologique Blvd.
Quebec City, Quebec, Canada G1P 4P5
ITEM 2. DATE OF MATERIAL CHANGE
September 24, 2003
ITEM 3. PRESS RELEASE
A press release was issued through Canada News Wire on
September 24, 2003
ITEM 4. SUMMARY OF MATERIAL CHANGE
AEterna reported the results of the Phase III trial in renal cell
carncinoma evaluating Neovastat, the Corporation's antiangiogenic
compound, and the results showed that the study did not meet its
primary endpoint of improving overall median survival time.
However, significant survival advantage was observed in a subgroup
of healthier patients with clear cell histology and only a single
metastatic site. This 38 patient subgroup showed a median survival
time of 26.3 months for those treated with Neovastat compared to
12.6 months for patients receiving a placebo (p = 0.0236).
This randomized, double-blind, placebo-controlled study was
conducted in approximately 50 hospitals and clinical centers
throughout Canada, the United
States and Europe. It was designed to evaluate the efficacy of
AEterna's antiangiogenic treatment, Neovastat, in prolonging
survival of patients with progressive metastatic renal cell
carcinoma, refractory to immunotherapy.
Patient recruitment opened in May 2000 and was completed in
December 2001. The trial involved 305 patients who had failed to
respond to immunotherapy. From this number, 153 patients were
administered Neovastat, while 152 patients were given a placebo.
Overall median survival for the Neovastat group was 12.4 months
compared to 12.3 months for the placebo group. Analysis of a
pre-planned stratification showed that healthier patients with
clear cell histology showed statistically significant clinical
benefit, 26.3 months for Neovastat versus 12.6 months for the
placebo group.
ITEM 6. RELIANCE ON PROVISIONS APPLYING TO THE CONFIDENTIAL FILING
N/A
ITEM 7. OMITTED INFORMATION
N/A
ITEM 8. SENIOR OFFICER
For further information, please contact:
Claude Vadboncoeur
Vice President, Legal Affairs and Corporate Secretary
Tel.: (418) 652-8525
ITEM 9. STATEMENT OF SENIOR OFFICER
The foregoing accurately discloses the material change referred to
herein.
This report is executed at Quebec City on this 3rd day of October 2003.
(SIGNED) CLAUDE VADBONCOEUR
--------------------------------------
Claude Vadboncoeur
Vice President, Legal Affairs
and Corporate Secretary
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
AETERNA LABORATORIES INC.
Date: October 3rd, 2003 by:
-----------------------------------
Claude Vadboncoeur
Vice President, Legal Affairs and
Corporate Secretary