D-Pharm Announces the Initiation of Phase II Clinical Trials For SPD 421 By Its Partner Shire Pharmaceuticals.Business Editors & Health/Medical Writers BIOWIRE2K REHOVOT, Israel--(BW HealthWire)--Oct. 15, 2001 D-Pharm Ltd. announced today that Shire Pharmaceuticals Group is initiating key Phase II clinical trials for its novel anti-epileptic agent, SPD (Serial Presence Detect) The method used by DIMM memory modules to communicate their capacity and features to the computer. Data such as manufacturer, size, speed, voltage and row and column addresses are stored in an EEPROM chip on the module. 421. The compound, previously known as DP-VPA, was discovered and developed by D-Pharm and its development and marketing was exclusively licensed to Shire in March 2000 subsequent to a successful Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I in 60 healthy volunteers. D-Pharm retained responsibility for production of SPD 421 both for clinical studies and marketing. The companies have since progressed through extensive pharmaceutical development and additional Phase I programs and now intend to intensify efforts to advance this product through advanced clinical development towards worldwide registration. SPD 421 is a unique phospholipid phospholipid (fŏs'fōlĭp`ĭd), lipid that in its simplest form is composed of glycerol bonded to two fatty acids and a phosphate group. derivative of valproic acid valproic acid /val·pro·ic ac·id/ (-ik) an anticonvulsant used particularly for the control of absence seizures. val·pro·ic acid n. An anticonvulsive drug used to treat seizure disorders. , a drug widely used for the treatment of epilepsy, bipolar disorder bipolar disorder, formerly manic-depressive disorder or manic-depression, severe mental disorder involving manic episodes that are usually accompanied by episodes of depression. and migraine prophylaxis. SPD 421 was created using D-Pharm's proprietary rational drug design technology known as Regulated Activation of Prodrugs (D-RAP(TM)), which enables precise control over drug action at the site of pathology. Preclinical data and Phase I results demonstrate unique safety and pharmacokinetic profiles of the drug compared to valproic acid. The first Phase II trial will be a multi-center, multi-national study of SPD 421 as add-on therapy in the treatment of complex partial seizures complex partial seizure n. Psychomotor epilepsy. complex partial seizure Complex seizure, partial complex seizure Neurology A brief, temporary seizure with multiple elaborate sensory, motor, or psychic components; . "The initiation of Phase II clinical trials by Shire represents a strategic developmental milestone developmental milestone Pediatrics Any of a series of activities, eg, raising the head, rolling over, walking or other significant points in a child's physical and/or mental development that may be used to assess maturation and detect developmental delays. event for D-Pharm," stated Dr. Alex Kozak, D-Pharm's 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. . "SPD 421 is D-Pharm's first and most advanced D-RAP(TM) product, so it is wonderful to see our partner, Shire Pharmaceuticals, committed to advance this unique compound through the development process." "We are impressed by the professional team efforts of our colleagues at Shire in progressing the clinical studies of SPD 421," said Dr. Itzchak Angel, D-Pharm's Vice President of R&D. "D-Pharm, on its part, continues its ongoing efforts for development of chemical process optimization and scale-up production of the drug substance," he added. The worldwide market for anti-epileptics in 1999 was valued at over $3.0 billion and is projected to grow to $4.5 billion by 2005. Yet, more than 25% of epilepsy patients are refractory to current anti-epileptic drug treatments, creating a significant unmet need. Patented formulations of valproic acid (Depakote(R), Depakine(R)) are first-line drugs of choice for epilepsy and generate approximately $900 million in sales for epilepsy, bipolar disorder and migraine prophylaxis indications. However, despite excellent efficacy, a variety of adverse effects limit valproic acid's maximum dose and extended use. SPD 421 is aimed at serving the needs of this market. `Composition of Matter' patents have been filed in all major countries worldwide and have already been granted in the US, Australia, New Zealand New Zealand (zē`lənd), island country (2005 est. pop. 4,035,000), 104,454 sq mi (270,534 sq km), in the S Pacific Ocean, over 1,000 mi (1,600 km) SE of Australia. The capital is Wellington; the largest city and leading port is Auckland. . Shire Pharmaceuticals Group plc Shire is a rapidly growing international specialty pharmaceutical company with a strategic focus on three therapeutic areas -- central nervous system disorders Nervous system disorders A satisfactory classification of diseases of the nervous system should include not only the type of reaction (congenital malformation, infection, trauma, neoplasm, vascular diseases, and degenerative, metabolic, toxic, or deficiency , oncology, antivirals -- and biologics. For further information on Shire Pharmaceuticals, please visit the company's website: www.shire.com D-Pharm Ltd. D-Pharm (www.dpharm.com) is an emerging biopharmaceutical company applying innovative drug re-engineering and discovery platform technologies to the development of new drugs. These include newly discovered compounds and improved, patent-protected derivatives of existing drugs for treatment of neurological disorders, cerebrovascular diseases, inflammation and cancer. D-Pharm has licensed worldwide rights to develop and market SPD 421 (DP-VPA) for epilepsy, bipolar disorder and migraine prophylaxis, to Shire Pharmaceuticals. The company has recently started enrolling patients into a Phase II Acute Stroke Study with D-Pharm's proprietary new drug -- DP-b99 which was designed and developed by D-Pharm Ltd as a novel neuroprotective agent neuroprotective agent Neurology Any agent or drug that protects the brain from secondary injury caused by stroke. See Stroke. . D-Pharm is also collaborating with Nycomed Amersham Imaging and with Eli Lilly & Company, on the application of its lipid vector technologies to their proprietary development candidates. |
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