RICHMOND HILL, Ontario, Nov. 13, 2018 (GLOBE NEWSWIRE) — Helix BioPharma Corp. (TSX, FSE: “HBP”), an immuno-oncology company developing drug candidates for the prevention and treatment of cancer, provides a strategic update of its L-DOS47 clinical program.
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.
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 and FSE under the symbol “HBP”.
Investor Relations
Helix BioPharma Corp.
9120 Leslie Street, Suite 205
Richmond Hill, Ontario, L4B 3J9
Tel: 905-841-2300
Email: [email protected]
Cautionary Statements
This news release may contain forward-looking statements and information (collectively, “forward-looking statements”) within the meaning of applicable Canadian securities laws. Forward-looking statements are statements and information that are not historical facts but instead include financial projections and estimates; statements regarding plans, goals, objectives, intentions and expectations with respect to Helix’s future business, operations, research and development, including Helix’s activities relating to its drug development program, the anticipated timelines for the commencement or completion of certain activities, including enrolment of patients, the expansion of the DOS47 platform into other compounds and indications and other information in future periods. Forward-looking statements, which may be identified by words including, without limitation, “encouraging”, “may”, “improve”, “planned”, “possible”, “postulated”, “enhances”, “potential”, “development”, “unique”, “expects”, “plans”, “will”, “intends”, “pending”, “objective”, “exploring”, “projected”, and other similar expressions, are intended to provide information about management’s current plans and expectations regarding future operations.
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. Risk factors that could cause actual results or events to differ materially from the forward-looking statements include, without limitation: (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) difficulties in predicting accurate timelines for the commencement or completion of certain activities including those in support of ongoing clinical trials; (iv) positive preliminary results from early-stage clinical trials may not be indicative of the final results from the trial or be indicative of favorable outcomes in later-stage clinical trials; (v) delays or inability to complete clinical trials successfully and the long lead-times and high costs associated with obtaining regulatory approval to market any product which may result from successful completion of such trials; (vi) clinical data may not demonstrate adequate efficacy and safety to result in regulatory approval to market any of Helix’s product candidates in any jurisdiction; (vii) economic and market conditions may become worse and market shifts may require a change in strategic focus; and (viii) those risks and uncertainties affecting Helix 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 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.
