Helix BioPharma Corp. Submits L-DOS47 Investigational New Drug Application with U.S. FDA
April 3, 2014 -- Helix BioPharma Corp. (TSX, FSE: “HBP”), a biopharmaceutical company developing innovative drug candidates for the prevention and treatment of cancer, today announced the recent submission of an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) for approval to initiate a Phase I clinical trial with L-DOS47. The study is entitled “A Phase I, Open Label, Dose Escalation Study of Immunoconjugate L-DOS47 in Combination with Standard Doublet Therapy of Pemetrexed/Carboplatin in Patients with Stage IV (TNM M1a and M1b) Recurrent or Metastatic Non-Squamous Non-Small Cell Lung Cancer (“NSCLC”).
“This is a very positive step forward in the development of L-DOS47” said Robert Verhagen, President and Chief Executive Officer of Helix. “While our Polish Study will provide vital information on our candidate as a monotherapy, our goal for this study, if approved by the FDA, will be to understand how L-DOS47 will work in combination with other chemotherapeutic agents”.
L-DOS47 is Helix’s first immunoconjugate-based drug candidate in development based upon the Company’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”).
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”.
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. Forward-looking statements, which may be identified by words including, without limitation, “will”, “may”, and other similar expressions, are intended to provide information about management’s current plans and expectations regarding Helix’s business and 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) the rejection by the FDA of the Company’s Investigational New Drug application; (ii) the need to secure additional financing in order to initiate the proposed U.S. Phase I clinical trial, and that such financing may not be available on terms satisfactory to Helix or at all; and (iii) 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 and assumptions are applied in making the forward-looking statements, including, without limitation, that the FDA will approve Helix’s Investigational New Drug application, that Helix is able to obtain financing on terms satisfactory to it (including the funding required to initiate the proposed U.S. Phase I clinical trial following approval by the FDA) and 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.
Source: Helix BioPharma Corp.
Posted: April 2014