more good news from DIATIDE
Monday June 7, 7:32 am Eastern Time
Company Press Release
Diatide Presents Phase III Data On NeoTect, 'Approvable' Lung Cancer Agent, and Other Studies At Society of Nuclear Medicine Meeting
UCLA Study Projects Multimillion Dollar Savings For Lung Cancer Diagnosis with NeoTect; Several studies on pipeline also presented
LOS ANGELES--(BW HealthWire)--June 7, 1999-- A multicenter Phase III clinical trial for NeoTect(TM) found the drug to be safe and effective for the detection of solitary pulmonary nodules, a prevalent form of lung cancer, according to Diatide, Inc. (NASDAQ:DITI - news). The Company presented 13 clinical and preclinical studies on its pipeline of noninvasive drugs for the detection and treatment of several major diseases, including cancer, acute blood clots, and severe infections. The presentations were made at the 1999 annual meeting of the Society of Nuclear Medicine here.
Diatide's core radiolabeled peptide technology platform was also the focus of a major educational session during the meeting, the first time the Society highlighted peptides for the detection of a wide range of tumors.
''This body of work represents substantial scientific recognition of Diatide's radiolabeled peptide technologies, and help to affirm our belief in the safety, cost efficacy and potential therapeutic benefits of our products,'' said Richard T. Dean, Ph.D., President and CEO of Diatide. ''The presented results from clinical studies of NeoTect(TM), which was recognized as 'approvable' by the Food and Drug Administration in December 1998, reinforce the drug's valuable potential for the detection of malignant lung tumors in patients with solitary pulmonary nodules.'' The nodules account for 20 percent of all lung cancer cases diagnosed each year.
''The Phase III data on AcuTect(TM), Diatide's approved product for the detection of acute blood clots in the legs, is also proving valuable in expanding physician awareness and adoption of this important agent,'' Dr. Dean said. ''The study confirmed the correlation between AcuTect and contrast venography, the internationally recognized gold standard for detecting deep vein thrombosis.''
Diatide's AcuTect(TM) and NeoTect(TM) are novel radiolabeled peptides that bind to cell receptors on acute blood clots in the leg and malignant tumors in the lung, respectively. The specific existence -- at the molecular level -- of the disease is imaged using widely available gamma cameras. Diatide's Techtide® and Theratide(TM) technology platform are being developed to help physicians locate and treat cancer, infectious disease, and other conditions. The company believes that its peptide technology offers significant advantages for safety, cost, and utility compared with monoclonal antibody-based pharmaceuticals.
Highlights of the presentations by Diatide and its academic collaborators include:
A prospective Phase III study in 114 patients at 19 medical institutions found that NeoTect(TM) was a safe and useful technique for the noninvasive evaluation of solitary pulmonary nodules (SPNs). NeoTect's sensitivity (96.6%) was found to be comparable to that reported for FDG-PET.
A related study examined prospective cost savings for NeoTect(TM) examinations, analyzing the same group of 114 patients with solitary pulmonary nodules. The evaluation, conducted by Dr. S. Gambhir et.al. at the UCLA School of Medicine, compared four diagnostic approaches. Life expectancies of the patients were calculated using an established model. The study found that utilizing NeoTect(TM) could save as much as $1,800 per year of life per patient, with up to $50.4 million potentially saved annually in the United States, compared with CT-based detection approaches.
A Phase III multicenter study of AcuTect involving 243 patients, led by clinicians at Centre Hospitalier Universitaire de Montreal, found that AcuTect(TM) (Technetium Tc 99m Apcitide Injection) has high sensitivity for imaging acute venous clots in the deep veins of the legs (deep vein thrombosis).
A fourth study reviewed results of a Phase II clinical trial of Diatide's lead infectious disease imaging agent, P483H. The drug, a platelet factor-4-derived radiolabeled peptide, was found to be safe and accurate in a study of 30 patients with either suspected or confirmed infections. Multiple sites of infection -- musculoskeletal, intra-abdominal, vascular graft, and central line -- were evaluated. Sensitivity, specificity and agreement rate compared with an institutional diagnosis were 82 percent, 77 percent, and 80 percent, respectively. The study was reported by Dr. CJ Palestro at Long Island Jewish Medical Center in New Hyde Park, NY.
In one of the first studies of its new therapeutic class of pharmaceuticals, Theratides, Diatide scientists presented data on the antitumor properties of Re-188-labeled P829 for pancreatic cancer. The study found that Re-188-labeled P829 significantly reduced the tumors containing somatostatin receptors in nude mice after 10 days of treatment.
''These studies and the other presentations at the SNM affirm the breadth and depth of our pipeline,'' said Dr. Dean. ''The potential of these new classes of drugs to substantially change the noninvasive diagnosis and treatment of several major diseases, including cancer, is very substantial.''
Diatide is a specialty pharmaceutical company developing a novel line of disease-specific imaging and therapeutic agents - Techtides® and Theratides(TM) -- as pharmaceuticals with commercial and medical promise. Diatide has applied its patented technologies in the areas of peptide engineering and radiolabeling chemistry to produce a number of small molecules that bind with high affinity and specificity to targets on diseased tissue and to which a radioisotope can be attached for imaging or therapeutic purposes.
On December 16, 1998, the Company received an approvable letter from the FDA, after a priority review, for its New Drug Application for NeoTect(TM), for the imaging of lung cancer. NeoTect(TM), is labeled with the imaging isotope technetium-99m and is the prototype for Diatide's ''Find, Fight, and Follow'' strategy in oncology. Diatide is in preclinical development of a compound using a targeting peptide, radiolabeled with the therapeutic beta-emitting radioisotope rhenium-188 for treating lung and breast cancer. On September 15, 1998 Diatide received marketing approval from the FDA, after a priority review, for AcuTect(TM) for the imaging of acute deep vein thrombosis (blood clots) in the lower extremities. For these two imaging products, Diatide has a marketing and sales collaboration with the UK-headquartered Nycomed Amersham plc. Diatide's therapeutic products are not currently the subject of any partnering agreements. To date, the Company has received 42 U.S. patents and has licensed the rights to seven more.
More information on the Company can be obtained from its Web site, diatide.com.
Clinical follow-up studies of patients with negative AcuTect scans have not been performed to determine if negative image findings mean the absence of acute venous thrombosis. If a patient has clinical signs and symptoms of acute venous thrombosis, a clinical management decision to withhold treatment with anticoagulants should not be based on a negative AcuTect study alone.
After administration of AcuTect, as with the administration of other intravenous drugs, patients with a history of drug reactions, other allergies, or immune system disorders should be observed for several hours.
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 - Risk Factors'' (''Risk Factors'') in the Company's Annual Report on Form 10-K for the year ended December 31, 1998 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; there can be no assurance that the claims allowed under the Company's issued patents will be broad enough to protect the Company's technology, that any patents issued to the Company will be sustained if challenged in court proceedings, or otherwise, or, that third parties will not develop products or processes that do not infringe any valid patents held by the Company; there can be no assurance as to when the FDA will complete its review of the NDA for NeoTect(TM) (P829); 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.
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Contact:
Diatide, Inc.
Richard T. Dean, Ph.D., (603) 437-8970 |
