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ConjuChem Completes Phase I DAC:TI Patient Enrolment

Release issued 13th May 2002

"Preliminary results from the trial demonstrate good safety and tolerability for DAC:TI up to the 200 mg dose level," said Dr. Jean-Paul Castaigne, Chief Scientific Officer of ConjuChem. "After reviewing the final data from this trial, we anticipate moving this compound into a much larger Phase II clinical trial later this year to evaluate its efficacy in the targeted indication."

Clinical Trial Design: The double blinded, ascending dose Phase I clinical trial was conducted in hemodialysis patients with arterial-venous shunts (AV shunts) who were undergoing a procedure to mechanically remove a clot that had formed in their shunts, to restore blood flow. Each patient received either drug or placebo administration into the shunt following the blood clot removal procedure and then followed for 28 days to assess safety/tolerability and maintenance of blood flow in the shunt. There were three cohorts (100mg, 200mg and 400 mg). Some of the patients at the highest dose are still in the 28-day follow-up period. This trial was an extension of a prior Phase I clinical trial that tested another, lower-concentrated formulation of DAC:TI at doses up to 50 mg.

About DAC:TI (CJC-1004): DAC:TI is a locally acting thrombin inhibitor with a long duration of activity for the prevention of localized clotting. It was designed to have similar anti-clotting therapeutic activity to current thrombin inhibitor drugs, but with little risk of the systemic side effects, such as bleeding, sometimes encountered with the use of these existing drugs. CJC-1004 is a compound derived by means of DAC technology from argatroban, a currently approved thrombin inhibitor for certain anti-clotting indications. The primary indication for which this drug is being developed is the treatment of AV shunts in hemodialysis patients to prevent clotting in those shunts. Most North American hemodialysis patients have surgically created AV shunts in order to provide the convenient, high flow, blood access required to perform kidney dialysis approximately three times per week in as short a time as possible. Though AV shunts serve this purpose well, they tend to develop blood clots over time that require the patient to undergo a surgical proceedure to enzymatically or mechanically remove the clot and attempt to re-establish blood flow. In most shunts the clotting process at some point becomes irreversible. The shunt must then be abandoned and a new shunt at a different site must then be surgically created. The consequence of this process is high medical cost and significant patient morbidity. CJC-1004 is applied into the AV shunt where it bonds to provide a long acting ant-clotting activity.

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If you want to find out more about the company visit ConjuChem Biotechnologies profile.

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Therapeutic target
Cardiovascular
Anticoagulants
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Biotechnology
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Prescription

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