antiquity
05-28-2002, 12:11 PM
EpiCept Reports Clinical Progress With Neuropathy Pain Product
ENGLEWOOD CLIFFS, N.J., May 28 /PRNewswire/ -- EpiCept Corporation, a specialty pharmaceutical company focusing on innovative pain relief therapies, today announced the progress of clinical trials for the treatment of neuropathic pain in the US and Canada.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020513/NYM112LOGO )
Under the direction of Dr. Earle Lockhart, Vice President Clinical and Regulatory Affairs, EpiCept recently initiated two multi-center clinical trials in Canada and the US following the clearance of IND filings last year at the FDA and Health Canada. The Phase II trials, which are double-blind and placebo-controlled will determine the clinical dose as well as the safety and efficacy of a novel topical drug combination of amitriptyline and ketamine for the relief of neuropathic pain. The initial results of these controlled trials are expected before the first quarter, 2003.
EpiCept's Chief Executive Officer, Jack Talley, commented, "Our Phase II study with EpiCept NP-1 in treating pain associated with various neuropathies is now underway. These studies are being conducted at over twenty centers in the US and Canada. We are pleased with the increasing pace of patient enrollment and continue to be enthusiastic about the potential outcome of this study based on positive results from an earlier pilot study conducted by Dr. Mary Lynch of the Queen Elizabeth II Hospital of Dalhousie University in Halifax, NS. Encouraging data from the initial open label clinical trial was already reported at the Canadian Pain Society Meeting in 2001."
About Neuropathic Pain
Neuropathic pain is due to disease, inflammation or damage to peripheral nerves. The most common causes are due to diabetes mellitus, trauma, chemotherapy, dietary deficiencies, viral infection and persistent excessive alcohol consumption. An estimated 2.6 million people in the United States suffer from chronic diabetic neuropathic pain alone. A very high unmet medical need exists for the treatment of neuropathic pain. EpiCept is developing a proprietary prescription topical cream based on a formulation containing the tricyclic antidepressant, amitriptyline plus the NMDA antagonist, ketamine. In open label studies in chronic neuropathic pain, remarkable pain relief has been noted in diabetic, traumatic and herpetic neuropathies.
About EpiCept
EpiCept is a specialty niche pharmaceutical company that applies proprietary topical technologies to develop new drugs and improved formulations of existing drugs for the prescription pain management market. The pain product candidates address unmet medical needs for lower back pain, post-operative incisional pain, neuropathic pain, and as well as other pain indications. EpiCept's product candidates offer potentially enhanced pain relief, improved side effect profiles, are potentially additive to systemically administered therapies, can eliminate systemic drug interactions and can be opioid sparing in their analgesic effect. The company is developing pain products for a focused set of clinical uses in back pain, surgical pain, and peripheral neuropathy.
EpiCept is a privately held company whose investors include major financial institutions. The management team is based at the corporate headquarters in Englewood Cliffs, N.J., and in Munich, Germany. More information about the company may be obtained from its Web site at: http://www.epicept.com.
ENGLEWOOD CLIFFS, N.J., May 28 /PRNewswire/ -- EpiCept Corporation, a specialty pharmaceutical company focusing on innovative pain relief therapies, today announced the progress of clinical trials for the treatment of neuropathic pain in the US and Canada.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020513/NYM112LOGO )
Under the direction of Dr. Earle Lockhart, Vice President Clinical and Regulatory Affairs, EpiCept recently initiated two multi-center clinical trials in Canada and the US following the clearance of IND filings last year at the FDA and Health Canada. The Phase II trials, which are double-blind and placebo-controlled will determine the clinical dose as well as the safety and efficacy of a novel topical drug combination of amitriptyline and ketamine for the relief of neuropathic pain. The initial results of these controlled trials are expected before the first quarter, 2003.
EpiCept's Chief Executive Officer, Jack Talley, commented, "Our Phase II study with EpiCept NP-1 in treating pain associated with various neuropathies is now underway. These studies are being conducted at over twenty centers in the US and Canada. We are pleased with the increasing pace of patient enrollment and continue to be enthusiastic about the potential outcome of this study based on positive results from an earlier pilot study conducted by Dr. Mary Lynch of the Queen Elizabeth II Hospital of Dalhousie University in Halifax, NS. Encouraging data from the initial open label clinical trial was already reported at the Canadian Pain Society Meeting in 2001."
About Neuropathic Pain
Neuropathic pain is due to disease, inflammation or damage to peripheral nerves. The most common causes are due to diabetes mellitus, trauma, chemotherapy, dietary deficiencies, viral infection and persistent excessive alcohol consumption. An estimated 2.6 million people in the United States suffer from chronic diabetic neuropathic pain alone. A very high unmet medical need exists for the treatment of neuropathic pain. EpiCept is developing a proprietary prescription topical cream based on a formulation containing the tricyclic antidepressant, amitriptyline plus the NMDA antagonist, ketamine. In open label studies in chronic neuropathic pain, remarkable pain relief has been noted in diabetic, traumatic and herpetic neuropathies.
About EpiCept
EpiCept is a specialty niche pharmaceutical company that applies proprietary topical technologies to develop new drugs and improved formulations of existing drugs for the prescription pain management market. The pain product candidates address unmet medical needs for lower back pain, post-operative incisional pain, neuropathic pain, and as well as other pain indications. EpiCept's product candidates offer potentially enhanced pain relief, improved side effect profiles, are potentially additive to systemically administered therapies, can eliminate systemic drug interactions and can be opioid sparing in their analgesic effect. The company is developing pain products for a focused set of clinical uses in back pain, surgical pain, and peripheral neuropathy.
EpiCept is a privately held company whose investors include major financial institutions. The management team is based at the corporate headquarters in Englewood Cliffs, N.J., and in Munich, Germany. More information about the company may be obtained from its Web site at: http://www.epicept.com.