RICHMOND HILL, ONTARIO–(Marketwired – Jan. 5, 2018) – Helix BioPharma Corp. (TSX:HBP)(FRANKFURT:HBP) (“Helix” or the “Company”), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, today announced it has been selected to present at the Biotech Showcase Conference on Monday, January 8, 2018 at 4:30pm (PT) at Hilton San Francisco Union Square.
Biotech Showcase Conference is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and pharmaceutical executives in one place during the course of one of the industry’s largest annual healthcare investor conferences, J.P. Morgan Annual Healthcare Conference.
During the conference, Helix will discuss its current development programs and opportunities for partnership. Helix will also update clinical progress on L-DOS47, its lead candidate for the treatment of non-squamous non-small cell lung cancer (“NSCLC”). L-DOS47 is being tested in three clinical programs (LDOS001, LDOS002, LDO003). A brief update on the progress of these trials is presented below.
LDOS001 is a Phase I, open label, dose escalation study being conducted in the United States. The primary objective of the study is to determine the safety and tolerability of L-DOS47 in combination treatment with pemetrexed/carboplatin in a first line setting in NSCLC patients. Nine (9) patients have been dosed so far in two cohorts. Four (4) confirmed partial response have been observed with one patient achieving a tumor volume reduction of 86%. LDOS001 has recently received FDA approval for an accelerated protocol. The company expects to enroll nine (9) additional patients to complete the study if no dose limiting toxicity is observed or cohort expansion is required due to safety concern. New clinical sites are currently being reviewed to help complete patient enrollment.
LDOS002 is a Phase I/II, open-label, non-randomized study designed to evaluate the safety and tolerability of ascending doses of L-DOS47, in mostly, previously treated late stage NSCLC patients. Primary study objectives are to determine the maximum tolerated doses (“MTD”) of L-DOS47 and to make a preliminary assessment of the efficacy of L-DOS47. Patients were given a weekly injection of L-DOS47 for two weeks followed by one week of rest before starting a new cycle of treatment. Fifty-five (55) patients received at least one dose of L-DOS47 in the phase I portion. Eleven (11) of 14 or 79% of patients in the highest dosing cohorts (5.76 to 13.55mcg/kg) had an overall tumour response of Stable Disease following the administration of two cycles of L-DOS47. L-DOS47 was well tolerated at the maximum dose of 13.55mcg/kg. Twenty-one (21) patients were successfully dosed in the first stage of the Phase II study. Phase II followed an intensified schedule of twice-weekly injection over 14 days followed by one week of rest. While the 13.55mcg/kg dose remained well tolerated, no additional benefits or confirmed tumor response meeting RECIST criteria were observed with the new schedule. The Company has decided not to continue with this study per the Trial Steering Committee’s recommendation but to focus on the primary objective to develop L-DOS47 as a combination drug product for cancer treatment.
LDOS003 is a European Phase II, open-label, randomized study of LDOS47 in combination with Vinorelbine/Cisplatin versus Vinorelbine/Cisplatin alone, in patients with lung adenocarcinoma. The clinical trial application is currently under review by regulatory agencies in Poland and Ukraine. Pending acceptance of Company’s responses to initial set of inquiries, patient enrollment may occur as early as the first quarter of 2018.
“Helix is making excellent progress in its DOS47 preclinical and clinical programs,” said Heman Chao, CEO. “I look forward to sharing in the conference our achievement to-date including our new cell therapy initiatives.”
Forward-looking statements include, without limitation, statements concerning (i) the Company’s ability to operate on a going concern being dependent mainly on obtaining additional financing; (ii) the Company’s priority continuing to be L-DOS47; (iii) the Company’s development programs for DOS47 and L-DOS47; (iv) future expenditures, the insufficiency of the Company’s current cash resources and the need for financing; and (v) future financing requirements and the seeking of additional funding. Forward-looking statements can further be identified by the use of forward-looking terminology such as “ongoing”, “estimates”, “expects”, or the negative thereof or any other variations thereon or comparable terminology referring to future events or results, or that events or conditions “will”, “may”, “could”, or “should” occur or be achieved, or comparable terminology referring to future events or results.
Although Helix believes that the expectations reflected in such forward-looking statements are reasonable, such statements involve risks and uncertainties that may cause actual results or events to differ materially from those anticipated and no assurance can be given that these expectations will be realized, and undue reliance should not be placed on such statements. Factors that could cause actual results or events to differ materially from the forward-looking statements include, without limitation, risks inherent in Helix’s research and development activities and those risks and uncertainties affecting the Company, as more fully described in Helix’s most recent Annual Information Form, including under the headings “Forward-Looking Statements” and “Risk Factors”, filed under Helix’s profile on SEDAR at www.sedar.com (together, the “Helix Risk Factors”). Certain material factors, estimates or assumptions have been applied in making forward-looking statements including, without limitation, the safety and efficacy of the Company’s drug product candidates; that sufficient financing will be obtained in a timely manner to allow the Company to continue operations and implement its clinical trials in the manner and on the timelines anticipated; the timely provision of services and supplies or other performance of contracts by third parties; future costs; the absence of any material changes in business strategy or plans; the timely receipt of required regulatory approvals and strategic partner support and that the factors described in the Helix Risk Factors will not cause the Company’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.
Helix BioPharma Corp.
9120 Leslie Street, Suite 205
Richmond Hill, Ontario, L4B 3J9