Sheffield Medical Technologies Inc. announced Tuesday thatCBR Laboratories Inc. (CBRL) has agreed to produce Sheffield'sred blood cell (RBC)-CD4 complex for use in upcoming Phase IIclinical trials in patients with HIV infection.
Under the terms of the agreement, Sheffield of Houston, Texas,will pay CBRL more than $300,000 for scaling up theelectroinsertion process by which the company inserts a full-length CD4 protein into red blood cells. CBRL is also being paidfor the equipment necessary to conduct the electroinsertionprocess, as well as delivering that equipment to Sheffield.
The electroinsertion process, for which Sheffield(NASDAQ:SHEF) received U.S. patent number 5,236,835 lastmonth, involves exposing RBCs to a pulsed electrical field thatenables the CD4 to be incorporated into the RBC's membrane,forming the RBC-CD4 complex. The complex acts like a spongefor free-floating HIV and forms aggregates with HIV-infectedcells. Once bound and internalized, the virus disintegrates andis no longer infective.
The contract between Sheffield and CBRL (a subsidiary of theCenter for Blood Research Inc., which is affiliated with HarvardMedical School) also provides for CBRL to actually perform theelectroinsertion process, producing clinical trial quantities ofthe RBC-CD4 complex.
This agreement extends a previous contract, signed in mid-July,by which Sheffield paid CBRL $1.19 million to produce purefull-length recombinant CD4 protein.
Sheffield now has in place the capabilities to produce clinicalscale quantities of RBC-CD4. It intends to start Phase II trialslater this year.
-- Jennifer Van Brunt Senior Editor
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