On November 13, 2018 Helix BioPharma Corp. (TSX, FSE: "HBP"), an immuno-oncology company developing drug candidates for the prevention and treatment of cancer, reported a strategic update of its LDOS47 clinical program (Press release, Helix BioPharma, NOV 13, 2018, View Source [SID1234531459]).

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Helix’s L-DOS47 strategic development plan has two parts. The first part is to ensure L-DOS47 will be used in a well-established treatment setting, while being ready to be applied in novel therapies. For this reason, L-DOS47 clinical programs will focus primarily in a combination setting. In this plan L-DOS47 will be studied with well-established chemotherapeutics and in combination with novel immunotherapy. The Company is well advanced in carrying out the study of L-DOS47 with chemotherapy in lung cancer. The planning for combining with immunotherapies in this indication is also in progress.

In the second part of the strategic development plan, the Company will focus on expanding the utility of L-DOS47 to indications other than lung cancer. In choosing a new indication for L-DOS47, the company has considered available preclinical and clinical L-DOS47 data, consulted with key opinion leaders and considered the best strategic application of limited financial resources. To this end, the Company has recently announced the start of a new pancreatic cancer program.

As of today, the Company has completed a monotherapy study of L-DOS47 in lung cancer, with two combination studies in the same indication that are actively recruiting patients. The Company is also working diligently to prepare for regulatory filing of a new pancreatic cancer study with the United Sates Food and Drug Administration ("FDA").

The following is a status update of active studies currently taking place.

LDOS001

LDOS001 is a Phase I dose escalation study of L-DOS47 with pemetrexed and carboplatin for the first line treatment in recurrent or metastatic non-squamous non-small cell lung cancer. A total of seven (7) cohorts comprising of L-DOS47 doses at 0.59, 0.78, 1.5, 3.0, 6.0, 9.0 and 12.0 ug/kg were approved. To date, five (5) cohorts have been completed and a total of 12 patients were dosed. No dose limiting toxicity was observed. In cohort 1, one patient had a partial response (36% tumor regression). In cohort 2, three other patients had partial response (40%, 44% and 91% tumor regression) and one additional patient experienced stable disease for 13.3 months. In cohort 4, one patient had a partial response (69% tumor regression). The company expects to enroll six more patients to complete recruitment for study dosing cohorts if no dose limiting toxicity is observed.

LDOS003

LDOS003 is a phase II, open-Label, randomized study of immunoconjugate L-DOS47 in combination with vinorelbine and cisplatin versus vinorelbine and cisplatin alone in patients with lung adenocarcinoma. Regulatory and Ethics approvals to dose patients were first received from Ukraine in March and from Poland in April. While the company had planned to enroll patient shortly thereafter, the program was delayed due to financial constraints. The company has recently reprioritized its resources and expects to enroll patients in this study immediately.

LDOS006

The Company recently announced the launch of a U.S. Phase I/II study of L-DOS47 in combination with doxorubicin for the treatment of metastatic pancreatic cancer. The study will be led by Dr. Daniel Von Hoff and his team. The Company is currently completing the study protocol and related documents necessary for an investigational new drug ("IND") application to the FDA.