Big move in NOVT based on the news below. NOVT says <The Company expects that patient enrollment into the Beta-Cath System Trial will now be finished by mid-year 1999.> Is this a big delay? NOVT says they are still track with START.
I missed the buying opportunity @ 18. It may have been a selling climax.
Friday March 12, 12:18 pm Eastern Time
Company Press Release
Novoste to Increase Enrollment in
Beta-Cath System Trial
START Trial on Schedule for Enrollment
Completion
NORCROSS, Ga.--(BW HealthWire)--March 12, 1999-- Novoste Corporation (Nasdaq:NOVT
- news) announced today that it is on track to complete enrollment of 1,100 patients into the
Beta-Cath(TM) System Trial by the end of this month.
However, the Company now plans to increase patient enrollment in the stent subgroup of the trial
by up to 300 patients pending FDA approval. The planned increase is a result of a recommendation
made by the Data Safety and Monitoring Board (DSMB) after its regularly scheduled meeting held
during the American College of Cardiology scientific sessions in New Orleans earlier this week.
The DSMB is an independent committee of clinicians and statisticians that have responsibility for
review of the study protocol and clinical events on regular intervals during patient enrollment into the
trial.
Based on the review of the currently available data set, the DSMB proposed increasing patient
enrollment in the stent subgroup to demonstrate the safety and effectiveness of the Beta-Cath
System Trial with the revised anti-platelet therapy protocol implemented in November 1998 to
address potential stent thrombosis concerns. The trial protocol was modified for the stent subgroup
to extend the anti-platelet therapy from two weeks to 60 days and to provide for additional
follow-up contact with these patients in the few months after treatment. The Company expects that
patient enrollment into the Beta-Cath System Trial will now be finished by mid-year 1999.
Novoste remains on track with its Stents And Radiation Trial (START) which is designed to
determine the safety and effectiveness of vascular brachytherapy in treating ''in-stent restenosis.''
The treatment of in-stent restenosis poses a difficult challenge to cardiologists because the
likelihood of a recurrent restenosis in previously stented patients is significantly higher than in the
general angioplasty or stent population, and currently there are no therapies which effectively treat
in-stent restenosis other than bypass surgery. As previously communicated, Novoste expects to
enroll approximately 386 patients into this trial by the second quarter of 1999, of which 299
patients have already been accrued. The data analysis center for both trials, the Cardiovascular
Data Analysis Center (CDAC), has reviewed the data to date and reported to the Company that
there are no similar stent thrombosis issues in the START Trial.
William A. Hawkins, President of Novoste, remarked, ''We remain committed to filing our PMA
application with the FDA in a timely fashion. Because changes to the Beta-Cath System Trial do
not affect the START Trial, we expect to complete enrollment in the START Trial as scheduled
during the second quarter of 1999, prior to completion of enrollment in the Beta-Cath System Trial.
The results of the START trial are now expected to be the basis of our initial PMA filing which
Novoste expects to file during the second quarter of 2000. We expect to file an amendment to our
PMA application during the third quarter of 2000 to seek approval for the clinical indications being
investigated in the Beta-Cath System Trial, or reduction of coronary restenosis following either
angioplasty or first time stent placement.''
Commenting on the trial modifications, Dr. Richard E. Kuntz, the Principal Investigator of the
Beta-Cath System Trial, said, ''We believe the decision to expand the stent subgroup of the
Beta-Cath System Trial is a positive change to the protocol. We continue to optimize vascular
brachytherapy over time, as is typical with new technologies.''
Novoste Corporation is a leader in the emerging field of vascular brachytherapy for the treatment of
restenosis. Brachytherapy is radiation therapy which is administered with a radioactive source
placed in or near the target tissue. For more information on the Company, please call Investor
Relations at Novoste at (770) 717-0904 or visit the Company's website, novoste.com.
The forward looking statements included in this news release, which reflect management's best
judgment based on factors currently known, involve risks and uncertainties including the
demonstration of safety and efficacy of the Beta-Cath System, receipt of regulatory approvals,
speed of patient enrollment, and other risks detailed in documents filed by Novoste with the SEC,
including forms 10-K and 10-Q.
Contact:
Novoste Corp., Norcross
Cheryl R. Johnson, 770/717-0904 |
