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Release issued 8th August 2002
MONTREAL, PQ, August 8, 2002 - ConjuChem Inc. (TSX:CJC), a Montreal-based biotechnology company, today announced results from three clinical trials of DAC(tm):Opioid (CJC-1008), a peripherally acting opioid drug for the treatment of moderate to severe pain. Two of these trials were Phase II proof of concept trials, one in patients undergoing Total Knee Replacement Surgery and one in patients suffering from Post Herpetic Neuralgia (PHN). A third trial was a repeat dose trial in healthy volunteers to assess the immunogenicity potential of the compound.
In the Phase II proof of concept trials, the preliminary results indicate the following: in the acute indication of total knee replacement surgery, there was no statistical sign of efficacy; in the chronic indication of PHN, there was statistical significance measurements of efficacy for DAC(tm):Opioid. Both trials demonstrated the compound has an excellent safety profile. In the repeat dose immunogenicity trial, there were no signs of an immunological response to DAC(tm):Opioid (the desired outcome). The Company has one more DAC(tm):Opioid Phase II proof of concept trial that is ongoing for the prevention of pain following hysterectomy surgery, which it intends to complete and report on in a couple of months.
"From a longer-term strategic perspective, the results from all three trials reinforce our confidence in the platform technology - it creates compounds with attractive safety profiles and desirable durations of activity," said Duffy DuFresne, President and CEO of ConjuChem. "Our reaction, naturally, is disappointment with the acute, post surgical results. We will need to carefully evaluate all the information with our clinical advisors to determine the future plans for the development of DAC(tm):Opioid."
The Company will be hosting a conference call to discuss these results and its next steps on Friday, August 9 at 10:00 a.m. The call will be audio-cast live and archived for 90 days at www.financialdisclosure.ca and www.conjuchem.com.
Subsequent to the final tabulation and analysis of the data, the Company intends to submit the full results of these trials for presentation at one or more future medical conferences.
Total Knee Replacement Surgery Trial
Clinical Trial Design This double-blinded trial involved the proof of concept testing of a single i.v. dose of CJC-1008 for the post surgical prevention and treatment of moderate to severe pain in patients undergoing total knee replacement surgery with either CJC-1008 or placebo. A total of 40 evaluable patients (21 placebo; 19 active) were treated in several US and Canadian centers. The primary efficacy endpoint of the study was the patient use of self-administered morphine (by means of a patient controlled analgesia (PCA) pump) in the 48 hours post surgery. Secondary efficacy assessments included Visual Analogue Scores (VAS) of pain intensity at a number of specific time points following the surgery procedure.
Clinical Trial Results CJC-1008 demonstrated no apparent efficacy as compared to placebo on the primary endpoint (use of PCA morphine in the 48 hours post-surgery). There were trends of CJC-1008 efficacy in the VAS assessments but this did not reach statistical significance for most of the time points.
Post Herpetic Neuralgia (PHN) Trial
Clinical Trial Design The other trial involved the double-blinded treatment of post-herpetic neuralgia (PHN) patients with both placebo and a single i.v. dose of CJC-1008 (crossover design) to compare efficacy of pain relief in the same patient. Thirty evaluable PHN patients with severe pain lasting a minimum of three months were treated at several US and Canadian centers. Each patient received a blinded dose of either placebo or DAC(tm):Opioid and was subsequently graded for pain relief based on VAS pain assessments at set periods of time post-dosing. Once each patient no longer experienced any pain relief from the initial compound (minimum of 24 hours and maximum of 28 days) he/she was crossed over to receive the alternate compound.
Clinical Trial Results VAS measurements of pain intensity showed evidence of analgesic efficacy for CJC-1008 versus placebo with statistical significance at most of the time points. Furthermore, following CJC-1008 administration, three patients demonstrated complete resolution of pain for the 28 day follow-up period (versus no patients following placebo administration).
Immunogenicity Trial
Clinical Trial Design This trial, conducted at a single US center, involved repeat administration of CJC-1008 to 12 healthy volunteers who had previously received doses of DAC(tm):Opioid as part of a Phase I clinical trial conducted in the latter half of 2001. After receiving CJC-1008 the subjects were assessed for clinical and biological signs of immunogenicity. Pharmacokinetic (PK) assessments of CJC-1008 blood levels at various time points were conducted in all patients following dose administration.
Clinical Trial Results No healthy volunteer showed clinical signs of immunogenicity to CJC-1008. There were no changes in any subject in the antigen specific IGG and IGE levels or in Total IGE levels. The PK profile of CJC-1008 in these subjects was consistent with the profile seen in the Phase I study.
About DAC(tm):Opioid (CJC-1008) DAC(tm):Opioid is a peripherally acting opioid agonist for the treatment of moderate to severe pain. It is 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/heartrate, narcotic addiction, sedation, etc.), or the severe constipation side effects encountered with existing opioid drugs. CJC-1008 is a compound derived from the naturally occurring opioid hormone in man, Dynorphin A. Though similar in therapeutic activity and potency, Dynorphin A has about a two minute half-life (a measure of the duration of therapeutic activity in the body) whereas the half-life of DAC(tm):Opioid in humans has been shown to be in excess of one week, potentially allowing for much less frequent and more convenient dosing requirements.
About ConjuChem Inc. ConjuChem Inc. is developing long-acting therapeutic compounds based on two novel product enabling platform technologies for in vivo bioconjugation. When applied to existing drugs, the Company's local and systemic DAC(tm) technology platforms enable the rapid creation of new drugs with significantly enhanced therapeutic properties as compared to the original drug compounds. Since the new drugs have biological activities that are patterned after existing drugs, these compounds can usually be developed more quickly, less expensively and at lower risk than most new chemical entities. The Company's platform technologies are focused on various therapeutic areas including oncology, pain, anti-virals, diabetes and thrombosis. ConjuChem has several early-stage research collaborations with biopharmaceutical companies.
Detailed descriptions of the Company, DAC(tm) technology and ConjuChem's product pipeline can be viewed on the Company's web page www.conjuchem.com.
If you want to find out more about the company visit ConjuChem Biotechnologies profile.
(8th August 2002) ConjuChem Discontinues DAC(tm):TI Development
(8th July 2002) ConjuChem Announces Start of Phase I Trial for DAC:GLP-1(TM), a Type 2
(13th May 2002) ConjuChem Announces Results of DAC:Opioid Repeat Dose Immunogenicity Trial
(13th May 2002) ConjuChem Completes Phase I DAC:TI Patient Enrolment
(15th March 2002) ConjuChem Enters Collaboration Agreement with Suntory Pharmaceutical Research Laboratories