SOURCE: Helix BioPharma Corp.

Helix BioPharma Corp.

September 08, 2015 08:00 ET

Helix BioPharma Corp. Gives Presentation and Update of L-DOS47 Clinical Study at World Conference on Lung Cancer

AURORA, ON--(Marketwired - Sep 8, 2015) - Helix BioPharma Corp. (TSX: HBP) (FSE: HBP), a biopharmaceutical company developing innovative drug candidates for the prevention and treatment of cancer, yesterday presented an update of the ongoing clinical study LDOS002 for their drug candidate L-DOS47 during the 16th World Conference on Lung Cancer held in Denver Colorado.

The presentation included the data from the ongoing Phase I/II open label dose escalation study of L-DOS47 as a monotherapy in non-squamous non-small cell lung cancer ("NSCLC") patients being conducted in five (5) medical centers in Poland ("LDOS002") and included the following highlights:

  • Forty (40) patients were enrolled in the first twelve dosing cohorts.
  • L-DOS47 was well tolerated at the dose levels up to 4.33 µg/kg.
  • No Dose Liming Toxicities ("DLT") were reported for Cohorts 1-12; one (1) DLT was reported for Cohort 13.
  • Adverse events reported to date were expected for the population under study.
  • Twenty-one (21) patients had an overall response of stable disease based on radiological assessment after completing two cycles of L-DOS47.
  • Eleven (11) of these 21 patients continued with a response of stable disease based on radiological assessment after completing four cycles of L-DOS47.
  • One patient in cohort 9 was dosed for ten (10) cycles (approximately seven (7) months) without disease progression.
  • The study is currently enrolling patients in the thirteen dosing cohort (5.76 µg/kg).

"We were honored to be selected to present at this important scientific meeting. We would like to thank our Polish Investigators for their continued support of the study LDOS002," said Rob Verhagen, CEO of Helix. "We will continue to analyse this data set from cohorts 1 to 12 and expect to provide further updates when available."

Data generated from the LDOS002 study supported the ongoing Phase I study in the U.S. investigating the combination of L-DOS47 with pemetrexed/carboplatin in late stage non-squamous NSCLC patients.

The abstract is available on the International Association for the Study of Lung Cancer ("IASLC") website. The 16th World Conference on Lung Cancer is the world's largest meeting dedicated to lung cancer and other thoracic malignancies organized by the IASLC. More than 7,000 delegates from more than 100 countries attended to discuss the latest developments in thoracic malignancy research.

L-DOS47 is Helix's first immunoconjugate-based drug candidate in development based upon Helix's novel DOS47 technology, which is designed to use an innovative approach to modify the microenvironmental conditions of cancer cells. L-DOS47 is currently being clinically evaluated as a treatment for certain patients with NSCLC.

L-DOS47 is currently being evaluated in two clinical studies; one in Poland and one in the United States.

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. The study commenced with a starting dose of 0.12 micrograms of L-DOS47 per kilogram of patient body weight in the first patient cohort. Patients enrolled in the thirteenth cohort will receive 5.76 micrograms of L-DOS47 per kilogram of patient body weight.

LDOS001 is a Phase I, open label, dose escalation study being conducted in the United States at three centers; The University of Texas, M.D. Anderson Cancer Centre, Penn State Milton S. Hershey Medical Center, and 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. Other exploratory objectives include the evaluation of the L-DOS47 pharmacokinetics and immunogenicity.

About Helix BioPharma Corp.

Helix is a biopharmaceutical company specializing in the field of cancer therapy. The Company is headquartered in Toronto, Canada with a wholly-owned subsidiary, Helix Polska, located in Warsaw, Poland. The company is actively developing innovative products for the prevention and treatment of cancer based on its proprietary technologies. The Company's product development initiatives are based on two innovative technology platforms: DOS-47, a novel candidate for treatment of malignant solid tumours and Biphasix formulations of Topical Interferon, used in treatment of precancerous cervical lesions.

Helix is currently listed on the TSX and FSE under the symbol "HBP".

This press release is not an offer of securities for sale in the United States. Helix's common shares have not been registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent an exemption from registration thereunder.

Forward-Looking Statements and Risks and Uncertainties

This news release contains certain forward-looking statements and information (collectively, "forward- looking statements") within the meaning of applicable Canadian securities laws, including, without limitation, those relating to Helix's expectation that it will provide updates on its LDOS002 clinical study, which may be identified by words including, without limitation, "expect" and other similar expressions, are intended to provide information about management's current plans and expectations regarding the conduct of the clinical studies of L-DOS47 and the other operations of Helix.

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) the inherent uncertainty involved in scientific research and drug development; (ii) the risks associated with delay or inability to complete clinical trials successfully, including 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; (iii) need to secure additional financing on terms satisfactory to Helix or at all; (iv) clinical trials that yield negative results, or results that do not justify future clinical development, including that LDOS002 will yield negative results and that the information, if any, gained from higher dose levels in such study will not be of use in future studies; and (v) 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 or assumptions are applied in making the forward-looking statements, including, without limitation, that the Helix Risk Factors will not cause Helix's actual results or events to differ materially from the forward-looking statements.

Forward-looking statements and information are based on the beliefs, assumptions and expectations of Helix's management on the date of this news release, and Helix does not assume any obligation to update any forward-looking statement or information should those beliefs, assumptions or expectations, or other circumstances change, except as required by law.

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