DITI has news out and I'm seeing MMs jockeying and some blocks going thru. Keep an eye on this one I think it might go quick.
Nescom out-
Medical Journal Reports Cancer Detection Method for Lung Tumors
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LONDONDERRY, N.H. (Jan. 14) BW HEALTHWIRE -Jan. 14, 1999--
Clinical Study Results Favorable for Diatide's NeoTect(tm),
Recently classified "Approvable" by the FDA
A new imaging agent, NeoTect(tm) allowed physicians to detect a prevalent type of lung cancer tumor,
without the need for costly or risky surgical procedures, according to a report of a clinical study published in
today's issue of CHEST. CHEST is the official scientific publication of the American College of Chest
Physicians. NeoTect(tm), recently classified "approvable" for the imaging of suspected malignant tumors in
the lung by the Food and Drug Administration (FDA), is being developed by Diatide, Inc. (Nasdaq:DITI).
According to authors of the study, the imaging agent NeoTect(tm) (formerly P829) may enable cost-effective
characterization of small lung tumors known as solitary pulmonary nodules (SPNs), without the need for risky
and costly surgical approaches. SPNs are responsible for approximately 20 percent of all new lung cancer cases
diagnosed each year. Since not all SPNs are malignant, the need for excluding benign SPNs without costly or
risky surgical procedures has been a source of serious investigation.
The CHEST article detailed a clinical study of 30 patients with SPNs seen on chest xray and significant risk
factors for lung cancer. In this group, 13 patients had cancer and 17 had benign processes all confirmed by
biopsy of the SPN. NeoTect(tm) was able to correctly identify or correctly exclude malignancy in 27 of the 30
patients. NeoTect(tm) evaluation is based on cost-effective and widely available noninvasive nuclear medicine
imaging technology.
"NeoTect(tm) has a strong affinity for the cell receptors known as somatostatin-type receptors that are found
in greater abundance on the surface of malignant lung tumors," said Jay E. Blum, M.D., Chief of Pulmonary
Medicine at CIGNA Healthcare of Arizona, Phoenix, Clinical Associate Professor of Medicine at the
University of Arizona, and co-author of the study paper. "This affinity, combined with NeoTect's radiolabelled
technetium-99m, a safe and inexpensive radioisotope imaged through widely available gamma camera systems,
allowed clinicians in the study to precisely distinguish the malignant versus the nonmalignant small tumors."
Blum continued, "Our results suggest that NeoTect's(tm) use in distinguishing between malignant and
non-malignant solitary pulmonary nodules (SPNs) is equivalent to a more costly, noninvasive technique known
as positron emission tomography imaging (FDG-PET). NeoTect(tm) also enabled more definitive diagnosis
than those generated through other noninvasive techniques, including CT scan and chest xray."
"This publication is important because it communicates to the medical community the potential for
NeoTect(tm) to identify lung cancer early without surgery or biopsy," said Richard T. Dean, Ph.D., President
and CEO of Diatide. "Once we market NeoTect(tm), physicians will have greater access to a more
cost-effective test with lower risks for detecting lung cancer than is currently available."
Lung cancer is the leading cause of cancer deaths worldwide. In 1995, the United States reported an estimated
170,000 new cases of lung cancer and 157,000 lung cancer deaths. Approximately 130,000 SPNs are
discovered each year; it is estimated that between 20 and 25 percent are malignant.
The New Drug Application (NDA) for NeoTect(tm) for the imaging of suspected malignant tumors in the lung
was granted "priority review" status by the FDA in June 1998 and received an approvable letter from the FDA
on December 17, 1998. The FDA confers priority review status on products that would offer significant
improvements in safety or effectiveness in the management of a serious or life-threatening disease, compared
with available therapies.
The CHEST report, "The Utility of a Somatostatin-Type Receptor Binding Peptide Radiopharmaceutical
(P829) in the Evaluation of Solitary Pulmonary Nodules," was co-authored by Jay Blum, M.D., Neal Rinne,
M.D., both with CIGNA Healthcare of Arizona, Phoenix, and Hirsch Handmaker, M.D., President of the
Healthcare Technology Group and a member of the scientific advisory committee of the Women's Cancer
Prevention Research Initiative of the Arizona Cancer Center in Phoenix. Dr. Handmaker is a scientific advisor
to Diatide and serves on the Company's Board of Directors.
Diatide is a specialty pharmaceutical company developing and marketing proprietary, disease-specific
pharmaceuticals for the diagnosis and treatment of life-threatening conditions. Diatide has applied its
proprietary technologies in the areas of peptide engineering and radiolabeling chemistry to produce a number
of peptides that bind with high affinity and specificity to molecular targets on diseased tissue and to which a
radioisotope can be attached for imaging or therapeutic purposes. The result is a development pipeline of
medical imaging products (Techtides(R)), and solid tumor and cardiovascular therapeutics (Theratides(R)). For
AcuTect(tm) and NeoTect(tm), Diatide has a marketing and sales collaboration with U.K.- headquartered
Nycomed Amersham plc, the world's leading diagnostic imaging company and one of the largest research-based
biotechnology suppliers to global markets.
Diatide is based in New Hampshire, where it conducts most of its research and development activities with a
staff of 90 full-time employees, including 15 Ph.D.s and two MDs on its research staff. More information on
the Company can be obtained from its web site, diatide.com.
This press release contains forward-looking statements that involve a number of risks and uncertainties. For
this purpose, any statements contained herein that are not statements of historical fact may be deemed to be
forward-looking statements. Without limiting the foregoing, the words "believes," "anticipates," "plans,"
"expects," "intends," and similar expressions are intended to identify forward-looking statements. Important
factors that could cause actual results to differ materially from those indicated by such forward-looking
statements are set forth under the caption "Item 7. Management's Discussion and Analysis of Financial
Condition and Results of Operations - Certain Factors That May Affect Future Results" ("Certain Factors") in
the Company's Annual Report on Form 10-K for the year ended December 31, 1997 which is on file with the
Securities and Exchange Commission. These Certain Factors are incorporated herein by reference. As more
fully described in the Certain Factors, the Company's potential products (other than AcuTect(tm)) are all still
in development. There can be no assurance that the Company's potential products will demonstrate the safety,
efficacy, and cost attributes currently expected by the Company, or that results from preliminary clinical
studies will be predictive of results that will be obtained in later clinical studies; there can be no assurance as to
when the FDA will complete its review of the NDA for NeoTect(tm) (P829); and, there can be no assurance
that the Company will receive regulatory approvals to commence or continue clinical trials of product
candidates, or to market any products, including NeoTect(tm); and, there can be no assurance that
AcuTect(tm), NeoTect(tm), or the Company's other potential products will be commercially successful, or
accepted by the medical community or third-party payors, or that technologies, patents and proposed products
of other companies will not render the Company's products obsolete or noncompetitive.
-0- mb/bos*
CONTACT: Diatide, Inc.
Daniel F. Harrington, 603-437-8970
KEYWORD: NEW HAMPSHIRE MASSACHUSETTS
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