BETHESDA, Md., July 10 /PRNewswire/ -- In two unanimous (9-0) votes, the
U.S. Food and Drug Administration Medical Imaging Drugs Advisory Committee
(MIDAC) today determined that LeuTech is safe and effective for use in the
diagnosis of appendicitis in patients with equivocal signs and symptoms and
that the data presented support the clinical utility of LeuTech in managing
these patients. LeuTech is a new radiopharmaceutical for imaging infection
sites developed by Palatin Technologies (Amex: PTN) of Princeton N.J.
The FDA will make its final decision on the Biologics License Application
of LeuTech based on a full review of the application and a review of the MIDAC
recommendation. Palatin and FDA agreed that any remaining issues in the BLA
can be resolved in the next two to three months.
"We are extremely pleased with the outcome of the advisory committee's
review of the LeuTech clinical data," said Charles L. Putnam, Palatin's COO
and executive vice president. "We have collaborated closely with the FDA
throughout the LeuTech development and testing process and will continue to do
so as we address any remaining issues."
Nearly 500,000 patients in the United States present to emergency
departments and physician offices each year with symptoms of appendicitis.
Approximately 250,000 of those cases are considered to be equivocal.
Appendicitis is the most common cause of acute abdominal pain requiring
surgical intervention.
Phase III clinical trial results were presented by Samuel Kipper, M.D.,
Medical Director of Nuclear Medicine, Tri-City Medical Center in Oceanside,
Calif., and Assistant Clinical Professor of Radiology at the University of
California, San Diego. The Phase III trials included 203 patients in ten sites
across the United States.
All patients in the Phase III trial presented to emergency departments
with signs and symptoms of equivocal appendicitis. A patient management plan
(surgery, admit for observation, or discharge to home) was developed by the
attending surgeon before and after the intravenous administration of LeuTech
in order to determine the impact of LeuTech on patient management. According
to the researchers, the probability of correctly diagnosing appendicitis was 6
to 13 times greater with the addition of LeuTech to the diagnostic process.
LeuTech demonstrated a 91 percent sensitivity, which is the ability to
detect disease when present, and 86 percent specificity, as determined by site
investigators. Also important, LeuTech demonstrated a negative predictive
value of 96 percent -- meaning surgeons could confidently discharge patients
with a negative scan rather than admit them into the hospital for observation
and additional tests.
The diagnostic efficacy of LeuTech was unchanged in a subgroup of 48
pediatric patients, and no serious or severe adverse affects were reported.
Finally, diagnostic images with LeuTech were achieved within eight minutes
post-injection for 50 percent of patients and within 47 minutes for 90 percent
of patients.
In 1999, Palatin and Mallinckrodt (NYSE: MKG), one of the world's leading
providers of nuclear medicine products, entered into an agreement under which
Mallinckrodt will market and distribute LeuTech exclusively throughout the
world, except in Europe for which negotiations are underway. While there can
be no assurance of when and if the FDA will approve LeuTech for the diagnosis
of equivocal appendicitis, the companies believe that LeuTech could be
approved by the end of this year and be on the market in early 2001.
"LeuTech is one of the most exciting new radiopharmaceutical products to
emerge in quite some time," said Bradley J. Fercho, president of
Mallinckrodt's Imaging Group. "The clinical research has been well-received by
the imaging community and today's vote by the advisory panel is an important
milestone. We are actively preparing for the launch of LeuTech in the United
States, once full FDA approval is received."
Other LeuTech Clinical Trials
Palatin is also currently conducting multiple Phase II clinical trials
with LeuTech to demonstrate that the agent is safe and effective in diagnosing
various other types of infections, such as osteomyelitis and ulcerative
colitis . The Company believes that these trials will lead to additional
utility and indications for its LeuTech infection imaging agent
About Palatin
Palatin Technologies, Inc. is a development-stage medical technology
company developing and commercializing pharmaceutical products for diagnostic
imaging and therapy based on its proprietary monoclonal antibody radiolabeling
and enabling peptide platform technologies. Palatin's product pipeline
includes PT-141 a therapeutic for treating erectile dysfunction. For further
information visit the Palatin website at http://www.palatin.com.
For Palatin investor information, visit the Allen & Caron Inc website at
http://www.allencaron.com.
About Mallinckrodt
Mallinckrodt Inc. is a global manufacturer and marketer of specialty
medical products designed to sustain breathing, diagnose disease and relieve
pain. Named one of America's most admired medical products and equipment
companies by Fortune magazine, Mallinckrodt does business in more than 100
countries. In fiscal 1999, combined net sales were $2.6 billion for
Mallinckrodt's respiratory, imaging and pharmaceutical product lines. Based in
St. Louis, Mo., Mallinckrodt's website address is http://www.mallinckrodt.com.
Statements about the Companies' future expectations, including development
and regulatory plans, and all other statements in this document other than
historical facts are "forward-looking statements" within the meaning of
Section 27A of the Securities Act of 1933, Section 21E of the Securities
Exchange Act of 1934 and as that term is defined in the Private Securities
Litigation Reform Act of 1995. The Companies intend that such forward-looking
statements be subject to the safe harbors created thereby. Since these
statements involve risks and uncertainties and are subject to change at any
time, the Companies' actual results could differ materially from expected
results.
SOURCE Palatin Technologies, Inc.
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Related links:
http://www.palatin.com
Company News On-Call:
http://www.prnewswire.com/comp/440950.html or fax,
800-758-5804, ext. 440950
CONTACT:
Carl Spana, Ph.D., CEO of Palatin
Technologies, 609-520-1911, cspana@palatin.com or Mark Alvino,
(investors) of Allen & Caron Inc., 212-698-1360,
mark@allencaron.com or Barbara Abbett of Mallinckrodt Inc.,
314-654-5230, barbara.abbett@mkg.com or Tony Labriola of Mullen,
978-468-1155, ext. 2140, tlabriola@mullen.com
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