SOURCE: Helix BioPharma Corp.

Helix BioPharma Corp.

April 22, 2015 17:45 ET

Helix BioPharma Corp. Provides an Update on the U.S. Study of L-DOS47

AURORA, ON--(Marketwired - Apr 22, 2015) -  Helix BioPharma Corp. (TSX: HBP) (FRANKFURT: HBP)

NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRES OR DISSEMINATION IN THE UNITED STATES

First Patient Dosed and Three Clinical Sites Initiated

Helix BioPharma Corp. (TSX: HBP) (FRANKFURT: HBP), a biopharmaceutical company developing innovative drug candidates for the prevention and treatment of cancer, announced today that the first patient in the LDOS001 U.S. study ("LDOS001") has completed their first dose of L-DOS47.

Helix also announced that it has initiated the following three clinical centers for this study:

  • The University of Texas MD Anderson Cancer Center;
  • Penn State Milton S. Hershey Medical Center; and
  • University Hospitals Case Medical Center.

"We are very excited about the start of our first patient in the Company's first U.S. trial," states Robert A. Verhagen, President and CEO of Helix. "LDOS001 has the potential to add significant information on the use of L-DOS47 as a potential first-line therapy in combination with the standard of care in non-squamous non-small cell lung cancer. We would like to thank all sites for their participation in this study."

LDOS001 is a U.S. Phase I, open label, dose-escalation study to evaluate the safety and tolerability of ascending doses of L-DOS47 in combination with standard doublet chemotherapy of pemetrexed/carboplatin in patients with Stage IV (TNM M1a and M1b) recurrent or metastatic non-squamous non-small cell lung cancer ("NSCLC"). Helix will also evaluate preliminary efficacy through radiological assessments according to RECIST 1.1 criteria.

L-DOS47 is also currently being evaluated in an open-label Phase I/II clinical study in Poland ("LDOS002") for 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.

About L-DOS47

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 NSCLC.

About Helix BioPharma Corp.

Helix BioPharma Corp. is a biopharmaceutical 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 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 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 Information and Risks and Uncertainties

This news release contains certain forward-looking statements and information (collectively, "forward-looking information") within the meaning of applicable Canadian securities laws. Forward-looking information means disclosure regarding possible events, conditions or other matters that is based on assumptions about future economic conditions and courses of action and includes 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 L-DOS47 and other information in future periods. Forward-looking information includes, without limitation, statements relating to the patients participating in the LDOS001 and LDOS002 clinical studies and the potential of LDOS001 to provide information on the use of L-DOS47 as a potential first-line therapy in combination with the standard of care in NSCLC, and other statements which may be identified by words including, without limitation, "continue", "expect", "intend" and other similar expressions, which 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 information 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, that LDOS001 proceeds in a manner and on the timelines anticipated by Helix, 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) future expenditures and the 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 LDOS001 and/or LDOS002 will yield negative results; and (v) 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 or assumptions are applied in making the forward-looking information, including, without limitation, that the Helix Risk Factors will not cause Helix's actual results or events to differ materially from the forward-looking information.

Forward-looking information is 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 information should those beliefs, assumptions or expectations, or other circumstances change, except as required by law.

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