helix biopharma corp (HBP) Snapshot

Helix Biopharma Corp. announced unaudited consolidated earnings results for the third quarter and nine months ended April 30, 2013. For the quarter, the company reported loss before finance items of $2,214,000 against $3,222,000 a year ago. Net loss and total comprehensive loss from continuing operations was $2,155,000 against $3,236,000 a year ago. Net loss and total comprehensive loss was $2,224,000 against $2,868,000 a year ago. Net cash used in operating activities was $1,576,000 against $6,286,000 a year ago. The company reported net loss from continuing operations of $3,236,000 respectively for a loss per common share on continuing operations of $0.05. For the nine months, the company reported loss before finance items of $6,321,000 against $16,612,000 a year ago. Net loss and total comprehensive loss from continuing operations was $6,281,000 against $16,613,000 a year ago. Net profit and total comprehensive profit was $368,000 against net loss and total comprehensive loss of $15,568,000 a year ago. Net cash used in operating activities was $5,667,000 against $14,084,000 a year ago. The company reported net loss from continuing operations of $16,613,000 respectively for a loss per common share on continuing operations of $0.25.

Helix Biopharma Corp. announced the appointment of Stace Wills to the board of directors. Mr. Wills is a resident Canadian and his appointment was effective June 12, 2013. The company also announced that Andrew J. MacDougall, who had agreed to serve on the board of directors on an interim basis pending the appointment of a resident Canadian director to satisfy the statutory requirement for resident Canadians to comprise at least 25% of Helix's board of directors, voluntarily resigned as a director following the appointment of Mr. Wills.

Helix Biopharma Corp. announced the opening of patient screening for the fourth dose level cohort in its ongoing Phase I/II clinical safety, tolerability and preliminary efficacy study of L-DOS47 in Poland. This follows completion of the first treatment cycle in the three patients enrolled in the third dose level cohort, in which L-DOS47 therapy was well tolerated as reviewed by the Trial Steering Committee. Patients to be enrolled in the fourth cohort will receive the next L-DOS47 dose level as planned in the study protocol, 0.46 micrograms of L-DOS47 per kilogram of patient body weight. L-DOS47 is Helix's first immunoconjugate-based drug candidate in development based upon the Company's novel DOS47 technology, which is designed to use an innovative approach to modify the micro-environmental conditions of cancer cells in a manner that leads to their destruction. L-DOS47 is currently being clinically evaluated as a treatment for certain patients with non-small cell lung cancer. The Phase I/II clinical study is an open-label study to evaluate the safety, tolerability and preliminary efficacy of ascending doses of L-DOS47, initially as a monotherapy, in patients with inoperable, locally advanced, recurrent or metastatic, non-squamous, stage IIIb/IV NSCLC. The study commenced with a starting dose of 0.12 micrograms of L-DOS47 per kilogram of patient body weight in the first patient cohort. Patients enrolled in the study will receive two weekly doses of L-DOS47, administered as an intravenous infusion, over 14 days, followed by 7 days rest (one treatment cycle is 3 weeks). For each patient enrolled in the study, treatment with L-DOS47 will continue until the patient experiences disease progression or unacceptable toxicity, the patient withdraws consent, or the patient has completed four treatment cycles and does not wish to continue with additional cycles, whichever occurs first. After four treatment cycles, at the discretion of the treating investigator and in consultation with the medical monitor, patients who experience clinical benefit may be eligible to continue L-DOS47 for as long as the treatment is well tolerated and the clinical benefit is sustained. The total number of patients to be enrolled in the study will ultimately depend on how many ascending dose levels are required to reach the maximum tolerated dose (MTD); however, the Company currently anticipates that the study will enroll less than the estimated maximum of 48 patients in Phase I as previously reported. Twenty patients will be enrolled in the Phase II portion of the study at the MTD dose determined in Phase I. Study patients will be male or female, at least 18 years of age, with histologically confirmed non-small cell lung cancer. Patients will have an Eastern Cooperative Oncology Group performance status of 0-2 at the screening visit for this study, and will have at least one site of measurable disease per RECIST v1.1. Efficacy evaluation of L-DOS47 will be based upon response rate using the RECIST version 1.1 criteria, disease progression and survival. Monitoring will include radiologic evaluations every second treatment cycle.