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News Article | February 15, 2017
Site: www.marketwired.com

TORONTO, ON--(Marketwired - Feb 13, 2017) - Helix BioPharma Corp. (TSX: HBP) ( : HBP), a clinical stage immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, will be attending and/or presenting at the following conferences in the first half of 2017: Please come and meet Helix at: Patrick Frankham, Helix's COO will present and meet with companies through the conference one-to-one partnering portal. Helix is invited to attend and Heman Chao, Helix's CSO, will be a panelist on "Efficiencies of Molecular Medicine" panel discussion moderated by Dr. Robert Gillies 3. American Association of Cancer Research (AACR 2017) (Washington, DC) April 1 to 5 to hear about the latest CAR-T development. 4. American Society of Clinical Oncology (ASCO) 2017 (Chicago, Illinois) June 2 - 7 with an abstract submitted for current LDOS001 Phase I study in the US. The team will discuss latest clinical development of L-DOS47. About L-DOS47 L-DOS47 is Helix's first immunoconjugate-based drug candidate in development, based on Helix's novel DOS47 technology platform which the Company believes alters the tumor microenvironment from acidic to alkaline and is positioning its core technology in the field of immuno-oncology as a unique Tumour Defence Breaker™. The Company believes L-DOS47 represents an innovative approach in modifying the microenvironmental conditions of cancer cells which the Company also believes serves as a general defense against cancer drugs and immunotherapies. Breaking the tumor defense by changing the tumor microenvironment from acidic to alkaline represents one of the forgotten hallmarks of cancer. L-DOS47 is intended to offer an innovative approach to the first-line treatment of inoperable, locally advanced, recurrent or metastatic non-small cell lung cancer. L-DOS47 is currently being evaluated in two clinical studies, one in the United States ("LDOS001") and the other in Poland ("LDOS002"). About LDOS001 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 LDOS002 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 is being conducted at five Polish centers under the direction of Dr. Dariusz Kowalski at The Maria Sklodowska-Curie Memorial Cancer Centre & Institute of Oncology as the overall coordinating investigator, together with four other principal investigators: Prof. Cezary Szczylik, MD, PhD at the Military Medical Institute, Prof. Elzbieta Wiatr, MD, PhD at the National Tuberculosis and Lung Diseases Research Institute, Dr. Aleksandra Szczensa, MD, PhD at the Mazovian Center of Pulmonary Diseases and Tuberculosis in Otwock and Prof. Rodryg Ramlau, MD, PhD at the Department of Oncology, Poznan University of Medical Science. 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 Chimeric Antigen Receptor ("CAR") based cell therapies. Helix is currently listed on the TSX and FSE under the symbol "HBP". This news release may contain forward-looking statements and information (collectively, "forward-looking statements") within the meaning of applicable Canadian securities laws, including, without limitation, those relating to advancing the Company's LDOS001 and LDOS002 clinical studies and any of the Company's CAR-T solid tumor candidate toward clinical testing, which may be identified by words including, without limitation, "will", "may", "expect", "estimate", "anticipate", "intend", "believe" or "continue" or the negative thereof or similar variations, are intended to provide information about management's current plans and expectations. 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, 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 those 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. These cautionary statements qualify all such 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.


News Article | November 30, 2016
Site: www.marketwired.com

TORONTO, ON--(Marketwired - Nov 30, 2016) - Helix BioPharma Corp. (TSX: HBP) ( : HBP), a clinical stage immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, is pleased to announce that after reviewing safety data from the Phase I/II study of L-DOS47 in non-squamous non-small cell lung cancer (LDOS002), the U.S. Food and Drug Administration ("FDA") has accepted an accelerated escalation scheme for L-DOS47 dosing in the U.S. Phase I study (LDOS001) up to 12µg/kg in combination with pemetrexed/carboplatin. "We are pleased with the FDA response", said Steve Demas, Chief Medical Officer. "The accelerated scheme will advance the primary objective of the study to determine the maximum tolerated dose of L-DOS47 in combination with the approved first-line therapy for non-squamous non-small cell lung cancer." In preparing the protocol amendment for the LDOS001 study, the company submitted safety data from the ongoing Phase I/II dose escalation monotherapy study conducted in Poland (LDOS002). Results from the Phase I component of the LDOS002 study will be presented at the upcoming IASLC 17th World Conference on Lung Cancer meeting in Vienna on December 6th, 2016. L-DOS47 is Helix's first immunoconjugate-based drug candidate in development is based on Helix's novel DOS47 technology platform which the Company believes alters the tumor microenvironment from acidic to alkaline and is positioning its core technology in the field of immuno-oncology as a unique Tumour Defence Breaker™. The Company believes L-DOS47 represents an innovative approach in modifying the microenvironmental conditions of cancer cells which the Company also believes serves as a general defense against cancer drugs and immunotherapies. Breaking the tumor defense by changing the tumor micro environment from acidic to alkaline represents one of the forgotten hallmarks of cancer. L-DOS47 is intended to offer an innovative approach to the first-line treatment of inoperable, locally advanced, recurrent or metastatic non-small cell lung cancer. L-DOS47 is currently being evaluated in two clinical studies, one in the United States ("LDOS001") and the other in Poland ("LDOS002"). 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. 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 is being conducted at five Polish centers under the direction of Dr. Dariusz Kowalski at The Maria Sklodowska-Curie Memorial Cancer Centre & Institute of Oncology as the overall coordinating investigator, together with four other principal investigators: Prof. Cezary Szczylik, MD, PhD at the Military Medical Institute, Prof. Elzbieta Wiatr, MD, PhD at the National Tuberculosis and Lung Diseases Research Institute, Dr. Aleksandra Szczensa, MD, PhD at the Mazovian Center of Pulmonary Diseases and Tuberculosis in Otwock and Prof. Rodryg Ramlau, MD, PhD at the Department of Oncology, Poznan University of Medical Science. Helix BioPharma Corp. is an immuno-oncology 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. Helix is currently listed on the TSX and FSE under the symbol "HBP". This news release contains certain forward-looking statements and information (collectively, "forward-looking statements") within the meaning of applicable Canadian securities laws, without limitation, those relating to unique Tumour Defense Breaker™, which may be identified by words including, without limitation, "unique", "believes", "will", "may", "modifying", "anticipated", "intended", "build", "effective", "continuing progress" and other similar expressions, are intended to provide information about management's current plans and expectations. Forward-looking statements include, without limitation, statements concerning (i) the Company's ability to operate on a going concern being dependent mainly on obtaining additional financing; (ii) the Company's priority continuing to be L-DOS47; (iii) the Company's development programs for DOS47 and L-DOS47; (iv) future expenditures, the insufficiency of the Company's current cash resources and the need for financing; and (v) future financing requirements and the seeking of additional funding. Forward-looking statements can further be identified by the use of forward-looking terminology such as "ongoing", "estimates", "expects", or the negative thereof or any other variations thereon or comparable terminology referring to future events or results, or that events or conditions "will", "may", "could", or "should" occur or be achieved, or comparable terminology referring to future events or results. Forward-looking statements are statements about the future and are inherently uncertain, and are necessarily based upon a number of estimates and assumptions that are also uncertain. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, such statements involve risks and uncertainties, and undue reliance should not be placed on such statements. Forward-looking statements, including financial outlooks, are intended to provide information about management's current plans and expectations regarding future operations, including without limitation, future financing requirements, and may not be appropriate for other purposes. Certain material factors, estimates or assumptions have been applied in making forward-looking statements in this news release, including, but not limited to, the safety and efficacy of L-DOS47; that sufficient financing will be obtained in a timely manner to allow the Company to continue operations and implement its clinical trials in the manner and on the timelines anticipated; the timely provision of services and supplies or other performance of contracts by third parties; future costs; the absence of any material changes in business strategy or plans; and the timely receipt of required regulatory approvals and strategic partner support. The Company's actual results could differ materially from those anticipated in the forward-looking statements contained in this news release as a result of numerous known and unknown risks and uncertainties, including without limitation, the risk that the Company's assumptions may prove to be incorrect; the risk that additional financing may not be obtainable in a timely manner, or at all, and that clinical trials may not commence or complete within anticipated timelines or the anticipated budget or may fail; third party suppliers of necessary services or of drug product and other materials may fail to perform or be unwilling or unable to supply the Company, which could cause delay or cancellation of the Company's research and development activities; necessary regulatory approvals may not be granted or may be withdrawn; the Company may not be able to secure necessary strategic partner support; general economic conditions, intellectual property and insurance risks; changes in business strategy or plans; and other risks and uncertainties referred to elsewhere in this news release, any of which could cause actual results to vary materially from current results or the Company's anticipated future results. Certain of these risks and uncertainties, and others affecting the Company, are more fully described in Helix's Annual Information Form, in particular under the headings "Forward-looking Statements" and "Risk Factors", and other reports filed under the Company's profile on SEDAR at www.sedar.com from time to time. Forward-looking statements and information are based on the beliefs, assumptions, opinions and expectations of Helix's management on the date of this new release, and the Company does not assume any obligation to update any forward-looking statement or information should those beliefs, assumptions, opinions or expectations, or other circumstances change, except as required by law.


TORONTO, ON--(Marketwired - Dec 9, 2016) - Helix BioPharma Corp. (TSX: HBP) ( : HBP), a clinical stage immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, intends to meet a selection of Big Pharma and Big Biotech companies during the Annual JP Morgan Conference week in San Francisco during January 9-12, 2017. In addition, Helix has been selected to present at the Biotech Showcase Conference on Tuesday, January 10, 2016 at 9:30am at Hilton San Francisco Union Square, which runs in parallel to the JP Morgan Conference. The Biotech Showcase Conference is an investor and partnering conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and pharmaceutical executives in one place during the course of one of the industry's largest annual healthcare investor conferences. Investors and biopharmaceutical executives from around the world gather in San Francisco during this critical week which is widely viewed as setting the tone for the coming year. "The timing is perfect" says Anton Gueth, Managing Director of Evolution Life Science Partners, who coordinates and fosters Helix's business development activities, "Helix has generated a lot of brand-new clinical data with their unique Tumour Defence Breaker™." "Our DOS47's proposed mechanism of action suggests that nearly all immuno-oncology therapies, especially checkpoint inhibitors and CAR-T, may strongly benefit from a combination approach with our Tumour Defence Breaker™ (DOS47) as well as classical chemotherapeutics, e.g. carboplatin" outlined Dr. Sven Rohmann, Helix's Chief Executive Officer. About L-DOS47 L-DOS47 is Helix's first immunoconjugate-based drug candidate in development is based on Helix's novel DOS47 technology platform which the Company believes alters the tumor microenvironment from acidic to alkaline and is positioning its core technology in the field of immuno-oncology as a unique Tumour Defence Breaker™. The Company believes L-DOS47 represents an innovative approach in modifying the microenvironmental conditions of cancer cells which the Company also believes serves as a general defense against cancer drugs and immunotherapies. Breaking the tumor defense by changing the tumor micro environment from acidic to alkaline represents one of the forgotten hallmarks of cancer. L-DOS47 is intended to offer an innovative approach to the first-line treatment of inoperable, locally advanced, recurrent or metastatic non-small cell lung cancer. L-DOS47 is currently being evaluated in two clinical studies, one in the United States ("LDOS001") and the other in Poland ("LDOS002"). About LDOS001 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 LDOS002 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 is being conducted at five Polish centers under the direction of Dr. Dariusz Kowalski at The Maria Sklodowska-Curie Memorial Cancer Centre & Institute of Oncology as the overall coordinating investigator, together with four other principal investigators: Prof. Cezary Szczylik, MD, PhD at the Military Medical Institute, Prof. Elzbieta Wiatr, MD, PhD at the National Tuberculosis and Lung Diseases Research Institute, Dr. Aleksandra Szczensa, MD, PhD at the Mazovian Center of Pulmonary Diseases and Tuberculosis in Otwock and Prof. Rodryg Ramlau, MD, PhD at the Department of Oncology, Poznan University of Medical Science. About Helix BioPharma Corp. Helix BioPharma Corp. is an immuno-oncology 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. Helix is currently listed on the TSX and FSE under the symbol "HBP". Cautionary Statements This news release may contain 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 operations and strategy, its research and development activities and statements regarding Tumour Defense Breaker™, which may be identified by words including, without limitation, "unique", "believes", "will", "should", "may", "expects", "anticipates", "intends", "build", "effective", "continuing" and other similar expressions, are intended to provide information about management's current plans and expectations. 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. Factors that could cause actual results or events to differ materially from the forward-looking statements include, without limitation, risks inherent in Helix's research and development activities and 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, estimates or assumptions have been applied in making forward-looking statements, including, without limitation, the safety and efficacy of L-DOS47; that sufficient financing will be obtained in a timely manner to allow the Company to continue operations and implement its clinical trials in the manner and on the timelines anticipated; the timely provision of services and supplies or other performance of contracts by third parties; future costs; the absence of any material changes in business strategy or plans; the timely receipt of required regulatory approvals and strategic partner support and that the factors described in the Helix Risk Factors will not cause the Company's actual results or events to differ materially from the forward-looking statements. These cautionary statements qualify all such forward-looking statements. Forward-looking statements and information are based on the beliefs, assumptions, opinions and expectations of Helix's management on the date of this news release, and the Company does not assume any obligation to update any forward-looking statement or information should those beliefs, assumptions, opinions or expectations, or other circumstances change, except as required by law.


Phase I/II dose escalation study of immunoconjugate L-DOS47 as a monotherapy in non-squamous non-small cell lung cancer patients TORONTO, ON--(Marketwired - Nov 17, 2016) - Helix BioPharma Corp. (TSX: HBP) ( : HBP), a clinical stage immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, is pleased to announce that the Company's poster entitled: Phase I/II dose escalation study of immunoconjugate L-DOS47 as a monotherapy in non-squamous non-small cell lung cancer patients has been selected for poster presentation at the 17th World Conference on Lung Cancer ("WCLC") held in Vienna, Austria, December 4-7, 2016. A copy of the poster will be made available on the Company's website. The abstract will be available on the International Association for the Study of Lung Cancer website. The poster presentation will include a readout from the ongoing Phase I/II study LDOS002. Study objectives include the evaluation of the safety, tolerability and preliminary efficacy of ascending doses of L-DOS47. Presentation details are as follows: #4455 Poster Session on December 6, 2016 between 2:30 - 3:45PM (Hall B) Phase I/II dose escalation study of immunoconjugate L-DOS47 as a monotherapy in non-squamous non-small cell lung cancer patients 1Poznan University of Medical Sciences, Poznan/Poland, 2Oncology Centre - Institute M. Sklodowska - Curie in Warsaw, Warsaw/Poland, 3Military Institute of Medicine, Warsaw/Poland, 4Mazovian Center of Pulmonary Diseases and Tuberculosis, Otwock/Poland, 5National Tuberculosis and Lung Disease Research Institute, Warsaw/Poland, 6Helix BioPharma Corp., Aurora, ON/Canada. About L-DOS47 L-DOS47 is Helix's first immunoconjugate-based drug candidate in development is based on Helix's novel DOS47 technology platform which the Company believes alters the tumor microenvironment from acidic to alkaline and is positioning its core technology in the field of immuno-oncology as a unique Tumour Defence Breaker™. The Company believes L-DOS47 represents an innovative approach in modifying the microenvironmental conditions of cancer cells which the Company also believes serves as a general defense against cancer drugs and immunotherapies. Breaking the tumor defense by changing the tumor micro environment from acidic to alkaline represents one of the forgotten hallmarks of cancer. L-DOS47 is intended to offer an innovative approach to the first-line treatment of inoperable, locally advanced, recurrent or metastatic non-small cell lung cancer. L-DOS47 is currently being evaluated in two clinical studies, one in the United States ("LDOS001") and the other in Poland ("LDOS002"). 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. 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 is being conducted at five Polish centers under the direction of Dr. Dariusz Kowalski at The Maria Sklodowska-Curie Memorial Cancer Centre & Institute of Oncology as the overall coordinating investigator, together with four other principal investigators: Prof. Cezary Szczylik, MD, PhD at the Military Medical Institute, Prof. Elzbieta Wiatr, MD, PhD at the National Tuberculosis and Lung Diseases Research Institute, Dr. Aleksandra Szczensa, MD, PhD at the Mazovian Center of Pulmonary Diseases and Tuberculosis in Otwock and Prof. Rodryg Ramlau, MD, PhD at the Department of Oncology, Poznan University of Medical Science. Helix BioPharma Corp. is an immuno-oncology 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. Helix is currently listed on the TSX and FSE under the symbol "HBP." This news release contains certain forward-looking statements and information (collectively, "forward-looking statements") within the meaning of applicable Canadian securities laws, without limitation, those relating to unique Tumour Defense Breaker™, which may be identified by words including, without limitation, "unique", "believes" "will", "may", "modifying", "anticipated", "intended", "build". "effective", "continuing progress" and other similar expressions, are intended to provide information about management's current plans and expectations. Forward-looking statements include, without limitation, statements concerning (i) the Company's ability to operate on a going concern being dependent mainly on obtaining additional financing; (ii) the Company's priority continuing to be L-DOS47; (iii) the Company's development programs for DOS47 and L-DOS47; (iv) future expenditures, the insufficiency of the Company's current cash resources and the need for financing; and (v) future financing requirements and the seeking of additional funding. Forward-looking statements can further be identified by the use of forward-looking terminology such as "ongoing", "estimates", "expects", or the negative thereof or any other variations thereon or comparable terminology referring to future events or results, or that events or conditions "will", "may", "could", or "should" occur or be achieved, or comparable terminology referring to future events or results. Forward-looking statements are statements about the future and are inherently uncertain, and are necessarily based upon a number of estimates and assumptions that are also uncertain. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, such statements involve risks and uncertainties, and undue reliance should not be placed on such statements. Forward-looking statements, including financial outlooks, are intended to provide information about management's current plans and expectations regarding future operations, including without limitation, future financing requirements, and may not be appropriate for other purposes. Certain material factors, estimates or assumptions have been applied in making forward-looking statements in this news release, including, but not limited to, the safety and efficacy of L-DOS47; that sufficient financing will be obtained in a timely manner to allow the Company to continue operations and implement its clinical trials in the manner and on the timelines anticipated; the timely provision of services and supplies or other performance of contracts by third parties; future costs; the absence of any material changes in business strategy or plans; and the timely receipt of required regulatory approvals and strategic partner support. The Company's actual results could differ materially from those anticipated in the forward-looking statements contained in this news release as a result of numerous known and unknown risks and uncertainties, including without limitation, the risk that the Company's assumptions may prove to be incorrect; the risk that additional financing may not be obtainable in a timely manner, or at all, and that clinical trials may not commence or complete within anticipated timelines or the anticipated budget or may fail; third party suppliers of necessary services or of drug product and other materials may fail to perform or be unwilling or unable to supply the Company, which could cause delay or cancellation of the Company's research and development activities; necessary regulatory approvals may not be granted or may be withdrawn; the Company may not be able to secure necessary strategic partner support; general economic conditions, intellectual property and insurance risks; changes in business strategy or plans; and other risks and uncertainties referred to elsewhere in this news release, any of which could cause actual results to vary materially from current results or the Company's anticipated future results. Certain of these risks and uncertainties, and others affecting the Company, are more fully described in Helix's Annual Information Form, in particular under the headings "Forward-looking Statements" and "Risk Factors", and other reports filed under the Company's profile on SEDAR at www.sedar.com from time to time. Forward-looking statements and information are based on the beliefs, assumptions, opinions and expectations of Helix's management on the date of this new release, and the Company does not assume any obligation to update any forward-looking statement or information should those beliefs, assumptions, opinions or expectations, or other circumstances change, except as required by law.


Phase I/II dose escalation study of immunoconjugate L-DOS47 as a monotherapy in non-squamous non-small cell lung cancer patients TORONTO, ON--(Marketwired - Dec 6, 2016) - Helix BioPharma Corp. (TSX: HBP) ( : HBP), a clinical stage immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, announce that it presented topline data from its phase I/II dose escalation study of immunoconjugate L-DOS47 as a monotherapy in non-squamous non-small cell lung cancer patients at the 17th IASCLC World Conference on Lung Cancer ("WCLC") held in Vienna, Austria. This is a Phase I/II, open-label, non-randomised study designed to evaluate the safety and tolerability of ascending doses of study drug ("L-DOS47") in male and female patients aged ≥ 18 years old with Stage IIIb or IV non-squamous non-small cell lung cancer ("NSCLC"). The staging of NSCLC was conducted according to Tumour Node Metastases ("TNM"), 7th Edition. Patients were recruited into cohorts, with a minimum of three and a maximum of six patients per cohort. Primary study objectives included to determine the maximum tolerated doses of multiple rising doses of L-DOS47 and to make a preliminary assessment of the efficacy of L-DOS47. A total of ninety (90) patients were consented and screened for participation in the study. Fifty-five (55) patients were administered at least one dose of L-DOS47 at dose levels ranging from 0.12 to 13.55µg/kg. Twenty-one (21) patients completed four treatment cycles and sixteen (16) patients were administered additional L-DOS47 cycles. Forty-eight (48) or 85% of patients were Stage IV as assessed according to TNM, 7th edition and based on computed tomography (CT) scan. None of the patients had prior history of other malignancies or had a known history of central nervous system metastatic disease. Of the 390 doses administered to patients in the Phase I study, 96% were administered without a dose delay or dose interruption. Comparatively, patients in cohorts 13 to 16 (5.76 to 13.55µg/kg) were exposed to more L-DOS47 for a longer duration without a significant change to the safety profile of L-DOS47 compared to the other dosing cohorts. Forty-four (44), or 80% of the patients in the safety population had at least one treatment emergent adverse events. The only dose limiting toxicity reported was a grade 4 bone pain resulting in the permanent discontinuation of L-DOS47. L-DOS47 did not elicit a dose-dependent release of cytokines at doses up to 13.55µg/kg. The MTD of L-DOS47 was not reached in the Phase I component of study LDOS002 at doses administered up to 13.55µg/kg. L-DOS47 was well tolerated at all dose levels up to 13.55µg/kg. Forty-seven (47) of the 55 patient dosed in the Phase I component of the study contributed to the response evaluable population. A dose response trend was observed when comparing the percentage of patients who were progression free at 16 weeks across dose ranges. A similar trend was observed when comparing the percentage of patient who had an overall tumour response of Stable Disease (as defined in RECIST v1.1) and had a reduction in the sum of target lesions. Eleven (11) of 14 or 79% of patients in the highest dosing cohorts (5.76 to 13.55µg/kg) had an overall tumour response of Stable Disease following the administration of two cycles of L-DOS47. Seven (7) of 14 or 50% of patients in the same dosing cohorts had an overall tumour response of Stable Disease and a reduction in the sum of target lesions and 57% of patients were progression free for greater than 16 weeks. "We are very encouraged by both the safety and efficacy data from the study", said Dr. Sven Rohmann, Helix's Chief Executive Officer. "This is a major milestone for the company and for our immuno-oncology program". Following the review of clinical data collected to-date, L-DOS47 has achieved many of the goals of early phase study; namely to determine the initial safety profile of the product and to acquire enough data to defend a proposed dose with which to subsequently test in various cancer indications. These data also suggest that L-DOS47 may be effective in treatment of CEACAM6 expressing tumors and may be more efficacious in combination with other therapies that may benefit from the pH-modulating effects of L-DOS47. About L-DOS47 L-DOS47 is Helix's first immunoconjugate-based drug candidate in development is based on Helix's novel DOS47 technology platform which the Company believes alters the tumor microenvironment from acidic to alkaline and is positioning its core technology in the field of immuno-oncology as a unique Tumour Defence Breaker™. The Company believes L-DOS47 represents an innovative approach in modifying the microenvironmental conditions of cancer cells which the Company also believes serves as a general defense against cancer drugs and immunotherapies. Breaking the tumor defense by changing the tumor micro environment from acidic to alkaline represents one of the forgotten hallmarks of cancer. L-DOS47 is intended to offer an innovative approach to the first-line treatment of inoperable, locally advanced, recurrent or metastatic non-small cell lung cancer. L-DOS47 is currently being evaluated in two clinical studies, one in the United States ("LDOS001") and the other in Poland ("LDOS002"). About LDOS001 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 LDOS002 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 is being conducted at five Polish centers under the direction of Dr. Dariusz Kowalski at The Maria Sklodowska-Curie Memorial Cancer Centre & Institute of Oncology as the overall coordinating investigator, together with four other principal investigators: Prof. Cezary Szczylik, MD, PhD at the Military Medical Institute, Prof. Elzbieta Wiatr, MD, PhD at the National Tuberculosis and Lung Diseases Research Institute, Dr. Aleksandra Szczensa, MD, PhD at the Mazovian Center of Pulmonary Diseases and Tuberculosis in Otwock and Prof. Rodryg Ramlau, MD, PhD at the Department of Oncology, Poznan University of Medical Science. About Helix BioPharma Corp. Helix BioPharma Corp. is an immuno-oncology 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. 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, without limitation, those relating to unique Tumour Defense Breaker™, which may be identified by words including, without limitation, "unique", "believes" "will", "may", "modifying", "anticipated", "intended", "build". "effective", "continuing progress" and other similar expressions, are intended to provide information about management's current plans and expectations. Forward-looking statements include, without limitation, statements concerning (i) the Company's ability to operate on a going concern being dependent mainly on obtaining additional financing; (ii) the Company's priority continuing to be L-DOS47; (iii) the Company's development programs for DOS47 and L-DOS47; (iv) future expenditures, the insufficiency of the Company's current cash resources and the need for financing; and (v) future financing requirements and the seeking of additional funding. Forward-looking statements can further be identified by the use of forward-looking terminology such as "ongoing", "estimates", "expects", or the negative thereof or any other variations thereon or comparable terminology referring to future events or results, or that events or conditions "will", "may", "could", or "should" occur or be achieved, or comparable terminology referring to future events or results. Forward-looking statements are statements about the future and are inherently uncertain, and are necessarily based upon a number of estimates and assumptions that are also uncertain. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, such statements involve risks and uncertainties, and undue reliance should not be placed on such statements. Forward-looking statements, including financial outlooks, are intended to provide information about management's current plans and expectations regarding future operations, including without limitation, future financing requirements, and may not be appropriate for other purposes. Certain material factors, estimates or assumptions have been applied in making forward-looking statements in this news release, including, but not limited to, the safety and efficacy of L-DOS47; that sufficient financing will be obtained in a timely manner to allow the Company to continue operations and implement its clinical trials in the manner and on the timelines anticipated; the timely provision of services and supplies or other performance of contracts by third parties; future costs; the absence of any material changes in business strategy or plans; and the timely receipt of required regulatory approvals and strategic partner support. The Company's actual results could differ materially from those anticipated in the forward-looking statements contained in this news release as a result of numerous known and unknown risks and uncertainties, including without limitation, the risk that the Company's assumptions may prove to be incorrect; the risk that additional financing may not be obtainable in a timely manner, or at all, and that clinical trials may not commence or complete within anticipated timelines or the anticipated budget or may fail; third party suppliers of necessary services or of drug product and other materials may fail to perform or be unwilling or unable to supply the Company, which could cause delay or cancellation of the Company's research and development activities; necessary regulatory approvals may not be granted or may be withdrawn; the Company may not be able to secure necessary strategic partner support; general economic conditions, intellectual property and insurance risks; changes in business strategy or plans; and other risks and uncertainties referred to elsewhere in this news release, any of which could cause actual results to vary materially from current results or the Company's anticipated future results. Certain of these risks and uncertainties, and others affecting the Company, are more fully described in Helix's Annual Information Form, in particular under the headings "Forward-looking Statements" and "Risk Factors", and other reports filed under the Company's profile on SEDAR at www.sedar.com from time to time. Forward-looking statements and information are based on the beliefs, assumptions, opinions and expectations of Helix's management on the date of this new release, and the Company does not assume any obligation to update any forward-looking statement or information should those beliefs, assumptions, opinions or expectations, or other circumstances change, except as required by law.


Quanjer P.H.,Erasmus Medical Center | Brazzale D.J.,Austin Hospital | Boros P.W.,National Tuberculosis and Lung Diseases Research Institute | Pretto J.J.,John Hunter Hospital
European Respiratory Journal | Year: 2013

The aim of this study was to determine the diagnostic and interpretative consequences of adopting the Global Lungs Initiative (GLI) 2012 spirometric prediction equations. We assessed spirometric records from 17 572 subjects (49.5% females), aged 18-85 years, from hospitals in Australia and Poland. We calculated predicted forced expiratory volume in 1 s (FEV1), forced expiratory volume (FVC), FEV1/ FVC and lower limits of normal (LLN) using European Community for Steel and Coal (ECSC), National Health and Nutrition Examination Survey (NHANES) III and GLI 2012 equations. Obstruction was defined as FEV1/FVCLLN and FVC20% underdiagnosis of airway obstruction up to the age of 55 years and to 16-23% overdiagnosis in older subjects. GLI 2012 equations increase the prevalence of a "restrictive spirometric pattern" compared to ECSC but decrease it compared to NHANES. Copyright ©ERS 2013.


Quanjer P.H.,Erasmus Medical Center | Weiner D.J.,Childrens Hospital of Pittsburgh | Pretto J.J.,John Hunter Hospital Newcastle | Pretto J.J.,University of Newcastle | And 2 more authors.
European Respiratory Journal | Year: 2014

The aim of this study was to determine the added value of measuring the forced expiratory flow at 25-75% of forced vital capacity (FVC) (FEF25-75%) and flow when 75% of FVC has been exhaled (FEF75%) over and above the measurement of the forced expiratory volume in 1 s (FEV1), FVC and FEV1/FVC ratio. We used spirometric measurements of FEV1, FVC and FEF25-75% from 11654 white males and 11113 white females, aged 3-94 years, routinely tested in the pulmonary function laboratories of four tertiary hospitals. FEF75% was available in 8254 males and 7407 females. Predicted values and lower limits of normal, defined as the fifth percentile, were calculated for FEV1, FVC, FEV1/FVC ratio, FEF25-75% and FEF75% using prediction equations from the Global Lung Function Initiative. There was very little discordance in classifying test results. FEF25-75% and FEF75% were below the normal range in only 2.75% and 1.29% of cases, respectively, whereas FEV1, FVC and FEV1/FVC ratio were within normal limits. Airways obstruction went undetected by FEF25-75% in 2.9% of cases and by FEF75% in 12.3% of cases. Maximum mid-expiratory flow and flow towards the end of the forced expiratory manoeuvre do not contribute usefully to clinical decision making over and above information from FEV1, FVC and FEV1/FVC ratio. Copyright © ERS 2014.

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