Adolor Corporation Initiates Second Phase 2 Study of Novel Delta Agonist.ADL5859 Being Studied in a Variety of Pain Indications EXTON, Pa. -- Adolor Corporation (Nasdaq:ADLR) announced today the initiation of a second Phase 2 study of ADL5859, a novel delta opioid opioid /opi·oid/ (o´pe-oid) 1. any synthetic narcotic that has opiate-like activities but is not derived from opium. 2. any of a group of naturally occurring peptides, e.g. agonist agonist /ag·o·nist/ (ag´ah-nist) 1. one involved in a struggle or competition. 2. agonistic muscle. 3. in development for the treatment of pain. Study 33CL232 will explore the analgesic analgesic (ăn'əljē`zĭk), any of a diverse group of drugs used to relieve pain. Analgesic drugs include the nonsteroidal anti-inflammatory drugs (NSAIDs) such as the salicylates, narcotic drugs such as morphine, and synthetic drugs efficacy of ADL5859 in treating inflammatory pain associated with rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. . "This study represents an important component of our ongoing program to assess our delta agonists across a number of pain conditions," said Michael R. Dougherty, president and chief executive officer of Adolor Corporation. "We believe there is a significant need for novel medicines to treat a variety of pain states, and are pleased to now begin our second Phase 2 study with ADL5859." Study 33CL232 is expected to enroll approximately 60 subjects, who will be scheduled to complete both a single dose phase and a subsequent multiple dose phase. Along with Study 33CL232, ADL5859 is being evaluated in an acute pain study, in a dental pain model (Study 33CL230) which commenced in the second quarter of this year. A third study in neuropathic pain is planned to start later this year. Additionally, Adolor expects to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for ADL5747, a second Delta agonist compound, in the fourth quarter of this year. About the Delta Receptor Program One of three opioid receptors Opioid receptors Receptors located in the brain and various organs that bind opiates or opioid substances. Mentioned in: Methadone opioid receptors, n.pl any of the several receptors to which opiates bind. , the Delta receptor has potential utility in a variety of indications, including the modulation of pain. Through a proprietary research platform based on cloned, human opioid receptors, Adolor has identified a series of novel, orally active Delta agonists - compounds that selectively stimulate the Delta opioid receptor δ-Opioid receptors are a class of opioid receptor which have enkephalins as their endogenous ligands. Function Activation of the receptors produces analgesia. Some research suggests that they may also be related to seizures. . Delta compounds may have a number of potential advantages, including an improved side effect profile, as compared to mu opioid receptor The μ opioid receptors (MOR) are a class of opioid receptors with high affinity for enkephalins and beta-endorphin but low affinity for dynorphins. The opiate alkaloids morphine and codeine are known to bind to this receptor. agonists. On the basis of preclinical evaluation in animal models of human conditions, one might expect a Delta agonist to show effect in inflammatory pain, among other pain conditions. In addition, Delta agonists are thought to modulate other biological processes that may manifest themselves in disease states or conditions such as cardioprotection, overactive bladder Overactive Bladder Definition Overactive bladder is the leakage of large amounts of urine at unexpected times, including during sleep. Description , and depression. There are currently no selective Delta agonists approved by the FDA. About Adolor Corporation Adolor Corporation (Nasdaq:ADLR) is a biopharmaceutical company specializing in the discovery, development and commercialization of novel prescription pain management products. Entereg[R] (alvimopan) is Adolor's lead product candidate under development for the management of the gastrointestinal side effects Side effects Effects of a proposed project on other parts of the firm. associated with opioid use. Adolor and GlaxoSmithKline (GSK GSK GlaxoSmithKline plc (pharmaceutical company) GSK Glycogen Synthase Kinase GSK Gruppentraining Sozialer Kompetenzen (Germany) GSK Greenland Shark (FAO fish species code) ) are collaborating in the worldwide development and commercialization of Entereg in multiple indications. Adolor also has a number of discovery research programs focused on the identification of novel compounds for the treatment of pain. By applying its knowledge and expertise in pain management, along with ingenuity, Adolor is seeking to make a positive difference for patients, caregivers and the medical community. For more information, visit www.adolor.com. This release, and oral statements made with respect to information contained in this release, constitute forward-looking statements within the meaning of 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. Such forward-looking statements include those which express plan, anticipation, intent, contingency, goals, targets or future development and/or otherwise are not statements of historical fact. These statements are based upon management's current expectations and are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. Such known risks and uncertainties relate to, among other factors: the risk that our Delta product candidates ADL5859 and ADL5747 will show adverse safety findings that make them unsuitable for further development; the risk that our Delta product candidates do not show utility in treating pain or any other clinical indications; the risk that we do not initiate further clinical studies for our product candidate ADL5859; the risk that we do not file an IND by the end of this year or at all for our product candidate ADL5747; the risk that filing targets for regulatory filings are not met; the costs, delays and uncertainties inherent in scientific research, drug development, clinical trials and the regulatory approval process; Adolor's history of operating losses since inception and its need for additional funds to operate its business; Adolor's reliance on its collaborators, including GlaxoSmithKline in connection with the development and commercialization of Entereg[R]; market acceptance of Adolor's products, if regulatory approval is achieved; reliance on third party manufacturers; product liability claims; competition; and securities litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. . Further information about these and other relevant risks and uncertainties may be found in Adolor's Reports on Form 8-K Form 8-K The form required by the SEC when a publicly held company incurs any event that might affect its financial situation or the share value of its stock. Form 8-K See 8-K. , 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Adolor urges you to carefully review and consider the disclosures found in its filings which are available in the SEC EDGAR Edgar or Eadgar (both: ĕd`gər), 943?–975, king of the English (959–75), son of Edmund, king of Wessex. In 957 the Mercians and Northumbrians rebelled against Edgar's brother Edwy and chose Edgar as their king. database at http://www.sec.gov and from Adolor at http://www.adolor.com. Given the uncertainties affecting pharmaceutical companies in the development stage, you are cautioned not to place undue reliance on any such forward-looking statements, any of which may turn out to be wrong due to inaccurate assumptions, unknown risks, uncertainties or other factors. Adolor undertakes no obligation to (and expressly disclaims any such obligation to) publicly update or revise the statements made herein or the risk factors that may relate thereto whether as a result of new information, future events, or otherwise. |
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