ConjuChem Obtains FDA Approval to Initiate Clinical Trials in Thrombosis.

Business Editors

MONTREAL--(BUSINESS WIRE)--July 17, 2000

CONJUCHEM INC. recently received approval from the FDA to begin a Phase I/II clinical trial of its lead compound, CCI-1004, a new generation thrombin inhibitor that prevents local blood clot formation.

The trials are to begin in July with 5 sites planned for the United States. The first phase, expected to be completed in September 2000, will be a dose escalation safety study involving drug applications in arterio-venous shunts in 12 hemodialysis patients. Once completed, trials on a main cohort of 30 hemodialysis patients will be conducted and completed by the first quarter of 2001.

Duffy DuFresne, CEO and President of CONJUCHEM INC. says, "This is the first clinical trial for CONJUCHEM, an important milestone that will further demonstrate the safety and clinical relevance of the company's in vivo bioconjugation technology. This product, CCI-1004, addresses a huge unmet medical need."

CONJUCHEM has targeted as primary indications for CCI-1004 applications in peripheral bypass grafts and arterial-venous (AV) shunts to prevent blood clotting. In contrast to systemic anticoagulants, CCI-1004 can be delivered locally to a defined site in the body. Because CCI-1004 bonds onto locally fixed proteins, high levels of sustained drug activity in a specific area are attained. This substantially limits the systemic exposure of CCI-1004 and reduces the side effects, such as systemic bleeding, observed with classic anticoagulants. CCI-1004 is the first thrombin inhibitor with sustained drug activity in a specific area and could potentially be used in all surgical procedures requiring a defined and localized administration of an anticoagulant for the prevention of clotting.

There are in excess of 150,000 chronic kidney failure patients in Canada and the US who undergo regular hemodialysis procedures to clean their blood. These patients have AV shunts (surgically created) to facilitate rapid, convenient blood access for hemodialysis. However, these AV shunts eventually develop obstructive blood clots, usually necessitating another surgery to create a new AV shunt. The Phase I/II trial of CCI-1004 will seek to prolong the effective life of patients' AV shunts; a currently unmet medical need.

CONJUCHEM INC. is developing long-acting therapeutic compounds based on two novel product enabling platform technologies for in vivo bioconjugation. It is exploiting this DAC Technology in various therapeutic areas including oncology, pain, anti-viral, diabetes and thrombosis. This technology is particularly well suited for creating new chemical entities with prolonged therapeutic activity for small organic molecules and therapeutic peptides. Targets include existing drugs, therapeutic compounds in development, or compound that have not been developed due to poor pharmacokinetics. Currently, the company has early stage collaborations with a number of pharmaceutical and biotechnology companies. CONJUCHEM is seeking to license its proprietary compounds: CCI-1004, and CCI-1008, a long-acting systemic opioid for pain management expected to enter human trials later this year.

Detailed descriptions of the company, DAC technology and CONJUCHEM's product pipeline can be viewed on the company's web page www.conjuchem.com.