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Helix Biopharma Corp. Announces Fiscal 2021 Year-End Results
RICHMOND HILL, ON / ACCESSWIRE / December 9, 2021 / Helix BioPharma Corp. (TSX:HBP), (" Hel...
About this update from Helix Biopharma Corp.
[{"type":"text","content":"Helix Biopharma Corp. Announces Fiscal 2021 Year-End ResultsRICHMOND HILL, ON / ACCESSWIRE / December 9, 2021 / Helix BioPharma Corp. (TSX:HBP), (\" Helix \" or the \" Company \"), a clinical-stage biopharmaceutical company developing unique therapies in the field of immuno-oncology based on its proprietary technological platform DOS47, today announced financial results for the 2021 fiscal year ended July 31, 2021.OVERVIEWThe Company reported a net loss and total comprehensive loss of $8,038,000 or $0.06 loss per common share for fiscal 2021 (2020 - $8,985,000 or $0.07 loss per common share).Clinical developmentPhase I combination therapy study in lung cancer (LDOS001):Final clinical study report expected to be completed in December 2021;Phase II combination therapy trial in lung cancer (LDOS003):Final clinical study report expected to be completed in March 2022 provided the Company settles a contractual disagreement with the clinical research organization engaged to oversee the study.The Company ceased patient enrolment into the trial in 2020 and proceeded to data analysis.As previously announced, the Company will not be advancing the randomized portion of the study without third-party partner funding. To date, no third-party partner has been identified.Phase Ib/II combination trial in pancreatic cancer (LDSOS006):Two dose limiting toxicity events (each, a \"DLT\") have been reported in the first cohort (\"Cohort 1\") of the trial. As a result of an amended protocol, an additional three (3) patients are required for this trial, bringing the total number of patients required to complete Cohort 1 to nine (9) patients. The Company currently continues to enroll patients in Cohort 1;If another DLT is observed in Cohort 1, the Company will not be able to complete the currently planned dose escalation plan, but instead will be required to design a protocol revision;On November 15, 2021, the Company applied for a revision to the clinical protocol to the U.S. Food and Drug Administration (\"FDA\").L-DOS47 immunotherapy chemo combination study in lung cancer:The Company engaged key opinion leaders on the feasibility and design of a possible immunotherapy chemo combination clinical study and had targeted a possible submission to the FDA by December 2021. The Company is not currently in a position to make a submission to the FDA regarding ...