HBP - L-DOS47 Phase II Randomized Study Advances to Second Cohort
RICHMOND HILL, Ontario, May 01, 2019 (GLOBE NEWSWIRE) -- Helix BioPharma Corp. (TSX: HBP), (“Helix” or the “Company”), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, has announced that the Trial Steering Committee ("TSC") reviewed safety data from the first dosing cohort of the Company’s LDOS003 study. No serious adverse events or dose limiting toxicities were observed. TSC recommended that Helix begin enrollment of patients into the second dosing cohort.
LDOS003 is a Phase II, open-label, randomized study of immunoconjugate L-DOS47 in combination with vinorelbine and cisplatin as compared to vinorelbine and cisplatin alone in patients with lung adenocarcinoma. The study is divided into two parts. In part I, the maximum tolerated dose of L-DOS47, when given in combination with vinorelbine/cisplatin, will be determined. Cohorts of 3 patients will be recruited into three dosing cohorts (6, 9 and 12 µg/kg). All patients at a given dose level must complete the first treatment cycle (3-week period) before escalation in subsequent patients can proceed. In part II, after the maximum tolerated dose of L-DOS47 in combination with vinorelbine/cisplatin has been determined, a further 118 patients will be randomized (1:1) to receive L-DOS47 in combination with vinorelbine/cisplatin, or vinorelbine/cisplatin alone.
“We are very encouraged that the first dosing cohort of this L-DOS47 phase II study in combination with chemotherapy has been completed,” said Heman Chao, Helix's Chief Executive Officer. “We look forward to receiving more data as we advance the L-DOS47 development program.”
About L-DOS47 clinical development
L-DOS47 is currently being clinically evaluated in three clinical studies, in the United States, Poland and Ukraine as a treatment for certain patients with non-small cell lung cancer (“NSCLC").
LDOS001 is a Phase I, open-label, dose escalation study being conducted in the United States at the University Hospitals Case Medical Center. The primary objective of the study is to determine the safety and tolerability of L-DOS47 in combination treatment with pemetrexed/carboplatin. The study will also evaluate the potential clinical benefit of L-DOS47 with this combination. Patient enrollment is active for this study.
LDOS002 is an open-label Phase I/II clinical study being conducted in Poland 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. Patient enrollment has completed for this study.
LDOS003 is a phase II, open-Label, randomized study of L-DOS47 in combination with vinorelbine/cisplatin as compared to vinorelbine/cisplatin alone in patients with Lung adenocarcinoma. The primary objectives of the study include safety, tolerability and efficacy of L-DOS47 in this combination treatment. Patient enrollment is about to commence for this study.
About Helix BioPharma Corp.
Helix BioPharma Corp. is an immuno-oncology company specializing in the field of cancer therapy. The company is actively developing innovative products for the prevention and treatment of cancer based on its proprietary technologies. Helix’s product development initiatives include its novel L-DOS47 new drug candidate and Chimeric Antigen Receptor (“CAR”) based cell therapies. Helix is currently listed on the TSX under the symbol “HBP”.
Cautionary Statements
This news release may contain forward-looking statements with respect to Helix, its operations, strategy, financial performance and condition, including its activities relating to its drug development program, any anticipated timelines for the commencement or completion of certain activities such as raising sufficient capital, merger and acquisition activity, listing on a U.S. exchange and other information in future periods. These statements generally can be identified by use of forward-looking words such as “may”, “will”, “expect”, “estimate”, “anticipate”, “intends”, “believe” or “continue” or the negative thereof or similar variations. The actual results and performance of discussed herein could differ materially from those expressed or implied by such statements. Such statements are qualified in their entirety by the inherent risks and uncertainties surrounding future expectations, including: (i) Helix’s ability to operate as a going concern being dependent mainly on securing sufficient additional financing in order to fund its ongoing research and development and other operating activities; (ii) the generally inherent uncertainty involved in scientific research and drug development and those specific to Helix’s pre-clinical and clinical development programs (DOS47, L-DOS47, V-DOS47 and CAR-T); (iii) that any transactions contemplated herein are completed; and (iv) those risks and uncertainties affecting Helix as more fully described in Helix’s most recent Annual Information Form, which is available at www.sedar.com (together, the “Helix Risk Factors”). Certain material factors and assumptions are applied in making the forward-looking statements, including, without limitation, that sufficient financing will be obtained in a timely manner to allow Helix to continue operations and implement its clinical trials in the manner and on the timelines anticipated and that the Helix Risk Factors will not cause Helix’s actual results or events to differ materially from the forward-looking statements. These cautionary statements qualify all such forward-looking statements.
Forward-looking statements and information are based on the beliefs, assumptions, opinions, plans and expectations of Helix’s management on the date of this news release, and the Company does not assume any obligation to update any forward-looking statement or information should those beliefs, assumptions, opinions, plans or expectations, or other circumstances change, except as required by law.
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