Helix BioPharma Corp. Initiates Enrollment for Thirteenth Cohort in Polish Phase I/II Clinical Study of its Lung Cancer Drug Candidate L-DOS47
Jun 22 15
Helix BioPharma Corp. announced the opening of patient screening for the thirteenth dose level cohort in its ongoing Phase I/II clinical safety, tolerability and preliminary efficacy study of L-DOS47 in Poland ("LDOS002"). The trial steering committee for LDOS002 has reviewed the safety data for the twelfth cohort and recommended that Helix begin enrollment of patients into the thirteenth cohort of LDOS002 as no dose limiting toxicities were observed. Based on safety information provided by Helix, the Central Ethics Committee and the Polish Competent Authority approved an additional four cohort dose levels which allows the trial steering committee to recommend dose escalation up to cohort sixteen. The additional four cohort dose levels (cohorts 13 to 16) are 5.76, 7.66, 10.19 and 13.55 µg/kg. Forty (40) patients have been successfully dosed in study LDOS002. The majority of these patients had received at least two prior lines of approved therapies before initiating treatment with the investigational product L-DOS47. Of these 40 patients: Seven (7) patients continued to receive investigational therapy past cycle 4; and One (1) patient in cohort 9 (1.84 µg/kg) completed 10 cycles of LDOS-47 treatment (progression free for approximately 7 months) before discontinuing the study. The decision to continue dosing is based on radiological assessments completed after every second cycle and clinical evaluation by the investigator. Helix currently intends to release information from a data review of the first 12 cohorts in the fourth calendar quarter of 2015, assuming the collection of data for cohort 12 patients proceeds as anticipated. L-DOS47 is Helix's immunoconjugate-based drug candidate in development based upon Helix's novel DOS47 technology, which is designed to use an innovative approach to modify the microenvironmental 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. L-DOS47 is currently being evaluated in two clinical studies in Poland and the United States.
Helix Biopharma Corp. Announces Unaudited Consolidated Earnings Results for the Third Quarter and Nine Months Ended April 30, 2015
Jun 15 15
Helix BioPharma Corp. announced unaudited consolidated earnings results for the third quarter and nine months ended April 30, 2015. For the quarter, the company reported Loss from operating activities before finance items was $1,903,000 against $2,114,000 a year ago. Loss and total comprehensive loss from continuing operations was $1,871,000 against $2,109,000 a year ago. Net loss was $1,821,000 or $0.03 per share against $2,109,000 or $0.03 per share a year ago.
For the nine months, the company reported Loss from operating activities before finance items was $6,656,000 against $6,932,000 a year ago. Loss and total comprehensive loss from continuing operations was $6,661,000 against $6,878,000 a year ago. Net loss was $6,611,000 or $0.09 per share against $6,878,000 or $0.10 per share a year ago. Cash used in operating activities was $6,144,000 against $6,364,000 a year ago.
Helix Biopharma Corp. Provides an Update on U.S. Study of L-DOS47
Apr 22 15
Helix BioPharma Corp. announced that the first patient in the LDOS001 U.S. study has completed their first dose of L-DOS47. The company also announced that it has initiated the following three clinical centers for this study: The University of Texas MD Anderson Cancer Center; Penn State Milton S. Hershey Medical Center; and University Hospitals Case Medical Center. LDOS001 is a U.S. Phase I, open label, dose-escalation study to evaluate the safety and tolerability of ascending doses of L-DOS47 in combination with standard doublet chemotherapy of pemetrexed/carboplatin in patients with Stage IV (TNM M1a and M1b) recurrent or metastatic non- squamous non-small cell lung cancer. Helix will also evaluate preliminary efficacy through radiological assessments according to RECIST 1.1 criteria. L-DOS47 is also currently being evaluated in an open-label Phase I/II clinical study in Poland for 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.