AURORA, ON -- (Marketwired) -- 06/22/15 -- Helix BioPharma Corp. (TSX: HBP) (FRANKFURT: HBP)
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Helix BioPharma Corp. (TSX: HBP) (FRANKFURT: HBP), a biopharmaceutical company developing innovative drug candidates for the prevention and treatment of cancer, today announced the opening of patient screening for the thirteenth dose level cohort in its ongoing Phase I/II clinical safety, tolerability and preliminary efficacy study of L-DOS47 in Poland ("LDOS002").
The trial steering committee for LDOS002 has reviewed the safety data for the twelfth cohort and recommended that Helix begin enrollment of patients into the thirteenth cohort of LDOS002 as no dose limiting toxicities were observed.
Based on safety information provided by Helix, the Central Ethics Committee and the Polish Competent Authority approved an additional four cohort dose levels which allows the trial steering committee to recommend dose escalation up to cohort sixteen. The additional four cohort dose levels (cohorts 13 to 16) are 5.76, 7.66, 10.19 and 13.55 µg/kg.
Forty (40) patients have been successfully dosed in study LDOS002. The majority of these patients had received at least two prior lines of approved therapies before initiating treatment with the investigational product L-DOS47. Of these 40 patients:
- Seven (7) patients continued to receive investigational therapy past cycle 4; and
- One (1) patient in cohort 9 (1.84 µg/kg) completed 10 cycles of LDOS-47 treatment (progression free for approximately 7 months) before discontinuing the study.
The decision to continue dosing is based on radiological assessments completed after every second cycle and clinical evaluation by the investigator. Helix currently intends to release information from a data review of the first 12 cohorts in the fourth calendar quarter of 2015, assuming the collection of data for cohort 12 patients proceeds as anticipated.
"As we continue to understand the safety of L-DOS47, we also learn about the potential clinical benefit to patients with non-small cell lung cancer", said Robert Verhagen, President and CEO of Helix. "We plan to continue dose escalation to maximize our flexibility of dosing and identifying optimal trial design parameters in future studies."
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. 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 to be enrolled in the thirteenth cohort will receive the next L-DOS47 dose level as planned in the study protocol, which is 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 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 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 financial performance that is based on assumptions about future economic conditions and courses of action and includes, without limitation, estimates relating to the total number of patients that will be enrolled in the Polish Phase I/II clinical study, the potential implications of continuing dose escalations on the flexibility of the clinical development for L-DOS47 in the future and the timing of the release of Helix's data review for the first 12 cohorts for LDOS002 and other information in future periods. Forward-looking information may be identified by words including, without limitation, "continue", "intends" 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.
Forward-looking information includes statements about the future and are inherently uncertain, and which are necessarily based upon a number of estimates and assumptions that are also uncertain. 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 information 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) 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 the Polish Phase I/II clinical trial for L-DOS47 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; (v) that data is not collected from cohort 12 of LDOS002 in a timely manner and that Helix is not able to complete its anticipated data review on the timelines anticipated or at all; and (vi) 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 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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