Palatin Technologies, Inc. Reports Positive LeuTech Data in Diabetic Patients with Suspected Pedal Osteomyelitis.Business Editors/Health/Medical Writers CRANBURY, N.J.--(BUSINESS WIRE)--April 24, 2003 Phase 2 Study Results Published in The Journal of Foot and Ankle Surgery Foot and Ankle Surgery is the sub-specialty of orthopedics surgery that deals with the treatment, diagnosis and prevention of disorders of the foot and ankle. Foot and ankle surgeons differ from podiatrist in that foot and ankle surgeons have received a medical doctorate and have Palatin Technologies, Inc. (AMEX AMEX See: American Stock Exchange :PTN PTN - Physical Transport Network ) announced today that positive results of a Phase 2 study to evaluate the efficacy of LeuTech(R) in diabetic patients with suspected pedal osteomyelitis osteomyelitis (ŏs'tēōmī'əlī`tĭs), infection of the bone and bone marrow. Direct infection of bone usually occurs through open fractures, penetrating wounds, or surgical operations. (infection in the bones of the foot) were published in the January/February 2003 issue of The Journal of Foot and Ankle Surgery. LeuTech is a product in development for infection imaging, based on a proprietary radiolabeled monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing . The study enrolled 25 diabetic patients with suspected pedal osteomyelitis and compared LeuTech with the current standard of care for imaging and diagnosing pedal osteomyelitis, Indium 111 labeled white blood cells White blood cells A group of several cell types that occur in the bloodstream and are essential for a properly functioning immune system. Mentioned in: Abscess Incision & Drainage, Bone Marrow Transplantation, Complement Deficiencies (111IN WBC WBC white blood cell; see leukocyte. WBC abbr. white blood cell WBC, n stands for white blood cell. ) in conjunction with a 3-phase bone scan Bone scan An x-ray study in which patients are given an intravenous injection of a small amount of a radioactive material that travels in the blood. When it reaches the bones, it can be detected by x ray to make a picture of their internal structure. . In this group of 25 patients, the accuracy of LeuTech and 111IN WBC were equivalent for both patients with and without pedal osteomyelitis; 10 patients had a positive diagnosis of pedal osteomyelitis and 15 patients were confirmed to have a negative diagnosis for osteomyelitis. The principal author of the manuscript, Christopher Palestro, M.D. at Long Island Jewish Medical Center Long Island Jewish Medical Center (LIJMC) shares the title of clinical and academic hub of the North Shore-Long Island Jewish Health System. It is an 827-bed voluntary, non-profit tertiary care teaching hospital serving the greater metropolitan New York area. in New York, concluded that LeuTech, which was easily and rapidly prepared, was safe and was comparable to 111IN WBC for diagnosing pedal osteomyelitis in diabetic patients. Dr. Palestro stated, "The results of this study are encouraging and, if confirmed in subsequent studies, would represent a significant advancement in the diagnosis of pedal osteomyelitis. LeuTech offers the advantage of direct injection and in-vivo labeling of white blood cells, whereas 111IN WBCs require a blood sample to be taken from the patient, processed by a nuclear pharmacy, and then re-injected into the patient." Carl Spana, Ph.D., President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Palatin Technologies stated, "This study supports our position that LeuTech can effectively meet the need for improved diagnosis of acute and chronic infections, including osteomyelitis. In this study, LeuTech provided equivalent efficacy to the current standard of care with the additional benefits of being faster and less invasive to the patient. We believe that once LeuTech is approved, given its time and safety advantages, it will rapidly replace current methods of ex-vivo white blood cell labeling." Palatin is currently conducting additional Phase 2 studies for other indications, including suspected occult infection and suspected post-surgical infection, wherein LeuTech and 111IN WBC imaging are also being directly compared. About Palatin Technologies, Inc. Palatin Technologies, Inc. (AMEX: PTN) is a biopharmaceutical company engaged in drug design and the development of innovative therapeutics. Palatin's patented drug discovery platform, MIDAS Midas (mī`dəs), in Greek mythology, king of Phrygia. Because he befriended Silenus, the oldest of the satyrs, Dionysus granted him the power to turn everything into gold by touch. (TM), streamlines the drug design process with an efficient approach to identify lead compounds from protein targets for drugs. The company is currently conducting clinical investigations with its lead drug, PT-141, for the treatment of male and female sexual dysfunction, and is developing additional therapeutic compounds discovered using its enabling peptide platform technology MIDAS to treat obesity, sexual dysfunction and inflammation. Additionally, Palatin is developing a product for infection imaging, LeuTech(R), based on a proprietary radiolabeled monoclonal antibody. For further information visit the Palatin web site at www.palatin.com. Statements about the Company's 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. The Company intends that such forward-looking statements be subject to the safe harbors created thereby. Palatin's actual results may differ materially from its historical results of operations and those discussed in the forward-looking statements for various reasons, including, but not limited to the Company's ability to carry out its business plan, successful development and commercial acceptance of its products, ability to fund development of technology, the risk that products may not result from development activities, protection of its intellectual property, ability to establish and successfully complete clinical trials for product approval, need for regulatory approvals, dependence on its partners for development of certain projects, and other factors discussed in the Company's periodic filings with the Securities and Exchange Commission. The Company is not responsible for events not updated after the date on this press release. |
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