Research & development
Research & development costs for the three and six month periods ended January 31, 2008, totaled $1,029,000 and $1,811,000, respectively, compared to $1,065,000 and $1,973,000, respectively, a year ago. In the three and six month periods ended January 31, 2008, research & development expenditures for both L-DOS47 and Topical Interferon Alpha2-b were less than in the same periods a year ago, with the majority of the lower research and development expenditures related to L-DOS47.
The reduction in research and development expenditures for L-DOS47 in the period were related to the various stages of completion associated with the multiple projects within the L-DOS47 program. Helix intends to seek approval in 2008 from the U.S. Food and Drug Administration ("FDA") for a Phase I clinical study in lung adenocarcinoma patients and, therefore, is currently advancing its L-DOS47 scale-up manufacturing program in anticipation of furnishing product for the clinical trial.
Research and development expenditures related to the Phase II trial in Sweden for ano-genital warts ("AGW") were more than offset by the reduction in costs associated with the Phase II study in Germany for women with precancerous, HPV induced low-grade cervical lesions.
The late-stage Phase II study in Germany was completed during the six
month period ended January 31, 2007. Based on the positive findings, the
Company is currently developing plans for a large, randomized,
placebo-controlled double-blind study to evaluate the product in an
expanded patient population in addition to preparatory work in anticipation
of Investigational New Drug ("IND") and Clinical Trial Application ("CTA")
|SOURCE Helix BioPharma Corp.|
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