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ConjuChem Announces Results of DAC:Opioid Repeat Dose Immunogenicity Trial

Release issued 13th May 2002

"We were unable to detect any clinical or biological signs of an immunogenic response to DAC:Opioid in patients who received a repeat dose of the compound as part of this trial," said Dr. Jean-Paul Castaigne, Chief Scientific Officer of ConjuChem. "We view this as another step in the process of demonstrating the safety of both DAC:Opioid and of the DAC Technology platform in general."

Clinical Trial Design and Preliminary Results: Twelve healthy volunteers who had originally received a single intravenous dose of DAC:Opioid as part of a Phase I clinical trial that concluded in October 2001 consented to receive another dose of DAC:Opioid as part of this trial. After having received this repeat dose, the subjects are now being followed for twelve weeks for clinical signs of immediate or delayed immunogenicity. The subjects are also being tested for antibodies to DAC:Opioid. To date, no adverse clinical response related to immunogenicity has been observed in any patient, and no antibody immune response or neutralizing antibody response to DAC:Opioid has been detected.

About DAC:Opioid (CJC-1008): DAC:Opioid is a peripherally acting opioid agonist for the treatment of moderate to severe pain. It was designed to have similar therapeutic activity to current synthetic opioid drugs such as morphine, but with little or none of the central side effects (e.g. depression of breathing/heart-rate, narcotic addiction, sedation, etc.) and severe constipation side effects sometimes encountered with existing opioid drugs. CJC-1008 is a compound derived from the naturally occurring opioid hormone in man, Dynorphin A and is similar in therapeutic activity and potency. However, whereas Dynorphin A has about a two minute half-life (a measure of the duration of therapeutic activity in the body), the half-life of DAC:Opioid in humans has been shown to be in excess of one week, potentially allowing for much less frequent and more convenient dosing requirements.

An intravenous formulation of CJC-1008 is currently being tested in three multi-center, single dose Phase II clinical trials, two involving the treatment and prevention of post-surgical pain and the third involving the treatment of post herpetic neuralgia, a type of neuropathic pain. Preliminary results of these trials are expected to be released in the third quarter of this year. A subcutaneous formulation of DAC:Opioid for the treatment of various types of chronic pain is expected to begin a multi-dose Phase I clinical trial this summer.

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