SOURCE: Helix BioPharma Corp.

Helix BioPharma Corp.

August 24, 2015 08:00 ET

Helix BioPharma Corp. Announces Upcoming Presentation of L-DOS47 at World Conference on Lung Cancer

AURORA, ON--(Marketwired - Aug 24, 2015) - Helix BioPharma Corp. (TSX: HBP) (FRANKFURT: HBP), a biopharmaceutical company developing innovative drug candidates for the prevention and treatment of cancer, today announced that an abstract for its lead lung cancer candidate L-DOS47 has been selected for oral presentation at the 16th World Conference on Lung Cancer (WCLC) held in Denver, Colorado, September 6-9, 2015.

The presentation will include the data from the ongoing Phase I/II open label, non-randomized dose escalation study of immunoconjugate L-DOS47 as a monotherapy in non-squamous non-small cell lung cancer patients (LDOS002).

Presentation details:
#3272 Oral Abstract Session 1 on September 7th, Room 401-404, 11:28 am MDT.
Phase I/II dose escalation study of immunoconjugate L-DOS47 as a monotherapy in non-squamous non-small cell lung cancer patients

Author(s): Dariusz Kowalski1, Cezary Szczylik2, Aleksandra Szczesna3, Rodryg Ramlau4, Elzbieta Wiatr5, Heman Chao6, Steve Demas6, Kazimierz Roszkowski-Śliż5

The Maria Sklodowska-Curie Institute of Oncology1, Warsaw, Poland; Military Institute of Health Institute2, Warsaw, Poland; Mazovian Centre of Pulmonary Diseases and Tuberculosis in Otwock3, Warsaw, Poland; Department of Oncology, Poznan University of Medical Sciences4, Poznan, Poland; National Tuberculosis and Lung Diseases Research Institute5, Warsaw, Poland, Helix BioPharma Corp.6, Aurora, Canada

Abstracts will be available online on the IASLC website.

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 in a manner that leads to their destruction. L-DOS47 is currently being clinically evaluated as a treatment for certain patients with non-small cell lung cancer ("NSCLC").

L-DOS47 is currently being evaluated in two clinical studies in Poland and 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.

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 BioPharma Corp. is a biopharmaceutical company specializing in the field of cancer therapy. Helix 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 its Topical Interferon Alpha-2b. 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 those which may be identified by words including, without limitation, "continue", "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 that patient recruitment for LDOS002 does not continue as scheduled or at all 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; (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 the Polish Phase I/II clinical trial for L-DOS47 will yield negative results; 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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