Tuesday August 29, 11:26 pm Eastern Time
Press Release
SOURCE: Gliatech Inc.
Gliatech Comments on FDA Observations
CLEVELAND, Aug. 29 /PRNewswire/ -- Gliatech Inc. (Nasdaq: GLIA - news) today issued a statement regarding the previous announcement regarding inspectional observations contained in a Form 483 report which identified certain items pertaining to the recording of the data and the process Gliatech used in recording and presenting this data to the U.S. Food and Drug Administration (``FDA'') with respect to the U.S. clinical trial of ADCON®-L.
The Pre-Market Approval (``PMA'') Application for ADCON®-L was approved by the FDA in May 1998. This PMA Application contained the results of a pivotal multi-center European clinical trial, as well as interim data from a U.S. clinical trial, which was in process at the time. The European pivotal clinical trial demonstrated that use of ADCON®-L resulted in a statistically significant reduction in the incidence of extensive scarring and that there is a statistically significant correlation between the presence of scarring and the recurrence of postoperative pain. As part of the FDA approval conditions of ADCON®-L to be marketed in the U.S., the Company was required to complete the U.S. clinical study and submit the results to the FDA for inclusion in the product labeling. Upon completion of the U.S. clinical study, the Company filed an amendment to its PMA Application containing among other things, a proposed change to its package insert incorporating the final results of this study.
In June 2000, the FDA began an audit of the results of the U.S. clinical study and issued inspectional observations contained in a Form 483, which identified certain items pertaining to the recording of the data and the process Gliatech used in recording and presenting this data to the FDA. On August 23, 2000 Gliatech was presented with a Form 483 by the FDA concerning conduct of this study. The primary effectiveness parameter for ADCON®-L in this study is the amount of scar around the spinal cord as determined by magnetic resonance imaging (MRI). To validate the readings of these MRI's, a separate study (Intraobserver Reliability Study) was performed in which 115 of 324 MRI's were read and scored a second time. The observations noted on this form include:
* The observations conclude that:
-- 32 of these 115 readings were different from the original scores.
-- The Intraobserver Reliability Study was only performed on data that
was not previously submitted to the FDA.
-- The Intraobserver Reliability Study scores were discussed in the
final ADCON®-L U.S. clinical study report submitted to the FDA
without notation or discussion with the FDA that such scores were a
result of a second reading of the MRI's.
-- During the audit, these second readings were compared to results
from the original MRI readings, and 29 of the 32 second scorings of
the MRI's resulted in a more favorable outcome for ADCON®-L than
did the original MRI data.
-- Six (6) of the second scorings of the MRI's had erasures or
write-overs and resulted in a more favorable outcome for ADCON®-L
than did the original MRI data.
* The observations noted that the Intraobserver Reliability Study was
performed to assess the reliability of the scar scores given by the
physician reading the original MRI's. He was to re-read some of the
MRI's that he had originally read and scored during the U.S. ADCON®-L
study. His re-read scores were to be compared to his original scores.
* Upon review of the study data, a photocopy of an unsigned MRI scoring
sheet, rather than the original data sheet, was found in one (1) out of
the 324 patient files. When the MRI was read a second time, the new
scores showed more scar present in this patient. This study data sheet
was for an ADCON®-L patient.
* The observations noted that six (6) out of the 280 evaluable patients
in the study did not meet all the required criteria for inclusion. One
additional patient was excluded and the observations noted that the FDA
disputed the criterion for the exclusion of such patient.
* In the clinical study, an MRI was to be obtained at 6 months
postoperatively. The observations noted that in approximately 14% of
the patients the MRI that was obtained was taken more than one month
late.
The Company is taking immediate steps to fully understand all issues involved in these matters. Specifically, the Company is conducting an investigation by an internal task force comprised of members of the Company's executive and clinical personnel who were not involved in the U.S. ADCON®-L clinical study, and the Company's Board of Directors has commissioned an investigation to begin immediately which will be conducted by external legal and regulatory experts. The results of this investigation will be presented to the Company's Board of Directors for determination of appropriate action.
The Company is committed to a full resolution of all Form 483 items and will be submitting the responses to the items cited in the Form 483 within 15 days. With respect to the current situation with the FDA, the Company is taking all appropriate steps to address the concerns raised by the FDA and to resolve those concerns in a manner satisfactory for Gliatech. The issuance of the FDA observations does not prohibit Gliatech from continuing to market ADCON®-L in the U.S.
Gliatech is engaged in the discovery and development of biosurgery and therapeutic products to improve surgical outcomes and to treat neurological disorders. The biosurgery products include the ADCON® family of products, which are designed to inhibit postsurgical scarring and adhesions, and a proprietary monoclonal antibody to treat anti-inflammatory disorders. Gliatech's neurological disorders programs are focused on development small molecule drug candidates to modulate the cognitive state of the nervous system and to treat the symptoms of schizophrenia.
Certain statements in this press release constitute ``forward-looking statements'' that are subject to risks and uncertainties which may cause the actual results of the Company to be different from expectations express or implied by such forward-looking statements. Such factors include, but are not limited to, uncertainty of market acceptance of the Company's products, the uncertainty of expenses associated with clinical trials and research efforts which may affect the continued profitability of the Company, uncertainty of regulatory approvals, the timing and content of decisions by the FDA, including the decisions with respect to the recent inspectional observations issued by the FDA, the uncertainty of market conditions and other risk factors detailed in the Company's SEC filings.
SOURCE: Gliatech Inc.
