On May 30, 2018 Helix BioPharma Corp. (TSX, FSE: HBP) ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported that the Safety Review Committee ("SRC") reviewed safety data from the third dosing cohort of the Company’s LDOS001 study and recommended that Helix begin enrollment of patients into the fourth dosing cohort (Press release, Helix BioPharma, MAY 30, 2018, http://www.helixbiopharma.com/helix-biopharma-corp-completes-third-dosing-cohort-initiates-enrollment-next-cohort-u-s-combination-treatment-study-lung-cancer-drug-candidate-l-dos47/ [SID1234527251]). LDOS001 is a dose escalation study of L-DOS47 with pemetrexed and carboplatin in recurrent or metastatic non-squamous non-small cell lung cancer. Patients enrolled in the fourth dosing cohort will receive the next L-DOS47 dose level which is 3.0 micrograms of L-DOS47 per kilogram of patient body weight.
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"We are very encouraged that L-DOS47 in combination with chemotherapeutics continues to be safe and well tolerated by patients," said Heman Chao, Helix’s Chief Executive Officer. "We look forward to completing this trial under an FDA approved amendment to accelerate dose escalation for this trial".
The following is an update regarding the LDOS001 trial:
No dose limiting toxicities reported at doses up to 1.5 µg/kg (cohort 3)
From imaging data available on the first nine patients, four confirmed partial response have been observed with one patient achieving a tumor volume reduction of 91%
Eight additional patients to complete the study if no dose limiting toxicity is observed or cohort expansion is required due to safety concern