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Helix, KBI Sign Clinical Development Lyo-Deal

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Helix BioPharma Corp. has signed an agreement with KBI Biopharma, Inc. to develop a process for preparing L-DOS47 in a lyophilized (freeze-dried powder) vial format for clinical testing.
   
“This new arrangement advances the Company closer to its objective of initiating clinical testing with L-DOS47,” said John Docherty, president of Helix. “The lyophilized packaging format will provide for optimum stability of L-DOS47 while in storage so that individual vials may be reconstituted in liquid form immediately prior to patient administration.”
   
L-DOS47 combines Helix’s DOS47 drug candidate with a highly specific single domain antibody to form a potential new, targeted drug product for the treatment of adenocarcinoma of the lung, the most common form of cancer. L-DOS47 is thought to work by leveraging a natural process in the body called the urea cycle to produce an anti-cancer effect. In 2008, the company plans to seek FDA approval to conduct a Phase I study with L-DOS47 in lung adenocarcinoma patients.

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