AURORA, ON--(Marketwire - January 07, 2011) -
Helix BioPharma Corp. (TSX: HBP
) (NYSE Amex: HBP
) (FRANKFURT: HBP), a developer of biopharmaceutical drug candidates for the prevention and treatment of cancer, today announced that it has filed an investigational new drug ("IND") application with the United States Food and Drug Administration ("FDA") seeking approval to perform its planned Phase I clinical safety and tolerability study of its cancer drug candidate L-DOS47.
L-DOS47 is the Company's first therapeutic immunoconjugate drug candidate under development based upon its novel DOS47 technology, which is designed to modify the microenvironmental conditions of cancer cells in a manner that leads to their destruction. 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 (NSCLC).
"This is a significant milestone for Helix. We are seeking approval to commence the much anticipated human clinical testing stage of development for this important new drug candidate," said John Docherty, president of Helix BioPharma Corp. "Having previously completed a pre-IND meeting with the FDA to identify its requirements for this IND filing, we are hoping that the review and approval process will proceed successfully."
The IND review process typically requires 30 days, during which the FDA will decide if an applicant is permitted to proceed with its proposed clinical trial.
About the Planned Phase I Study
The proposed Phase I study is planned to be an open-label, first-in-human study to primarily evaluate the safety and tolerability of L-DOS47. This study is therefore planned to be conducted in patients with refractory solid cancerous tumors of any type, with a view to maximizing the rate of patient recruitment. The study will begin with a dose of 0.13 micrograms of L-DOS47 per kilogram of patient body weight. L-DOS47 will be infused in ascending dose levels in groups of 3-to-6 patients per ascending dose level once weekly for three weeks followed by one week of rest (one treatment cycle = four weeks), over four planned treatment cycles. The total number of patients to be enrolled in the study will ultimately depend on how many ascending dose levels are required to reach the maximum tolerated dose (MTD); however, based on the Company's preclinical studies to-date, it currently estimates that the study will enroll approximately 30-to-50 patients in order to reach the MTD. Study patients will be male or female at least 18 years of age with histologically or cytologically confirmed stage IV solid cancerous tumors, which are deemed by their physician to be unresponsive to, or untreatable by, standard therapies. Patients will have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1 at the screening visit for this study, and will have at least one site of measurable disease per the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. After four treatment cycles, at the discretion of the investigator and in consultation with the medical monitor, patients who experience clinical benefit may be eligible to continue L-DOS47 for as long as the treatment is well tolerated and the clinical benefit is sustained. End of study is defined as 30 days after the last patient's last dose (last dose of treatment cycle four), or when all patients have discontinued, whichever occurs sooner.
Assuming required regulatory approvals in the U.S. and Europe respectively are obtained in a timely fashion, the Company plans to prioritize its current capital resources to initiating this U.S. Phase I study as well as a planned Polish Phase I/II study which is still under development; however, we are still in the process of gathering the required third-party service provider costing proposals to execute both studies and have not yet committed any funds for this purpose. Also, the Company will require additional capital in order to see both studies through to completion. While the Company does not have an estimated timeline for the completion of the U.S. or Polish studies, based on its current planned schedule, which includes estimates of patient availability and recruitment rate in the respective jurisdictions, it estimates that its U.S. Phase I study will have a duration of not less than 12 months and its Polish study a duration of not less than 18 months, followed by analysis and reporting of the trial results in each case.
L-DOS47 is the Company's first drug candidate under development based upon its DOS47 technology. L-DOS47 is a therapeutic immunoconjugate which combines Helix's DOS47 technology with a highly specialized camelid-derived single domain antibody designed to identify a unique CEACAM6 antigenic site predominantly associated with NSCLC cells. It is designed to function by leveraging a natural process in the body called the urea cycle, to produce an anti-cancer effect. It is based upon a naturally occurring enzyme called urease that essentially reverses the urea cycle by breaking down urea into metabolites that include ammonia and hydroxyl ions. By breaking down urea at the site of cancerous tissues in the body, L-DOS47 is believed to modify the microenvironmental conditions of cancer cells in a manner that leads to their death. Among these theorized effects, L-DOS47 is believed to stimulate an increase in the pH of the microenvironment surrounding the cancerous cells, effectively reversing the acidic extra-cellular conditions that are known to be necessary for cancer cell survival. As well, the local production of ammonia at the site of cancerous tissues is thought to readily diffuse into the cancer cells to exert a potent cytotoxic effect by interfering with their critical metabolic functions.
About Helix BioPharma Corp.
Helix BioPharma Corp. is a biopharmaceutical company focused on 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 Topical Interferon Alpha-2b and its novel L-DOS47 new drug candidate. Helix is listed on the TSX, NYSE Amex and FSE under the symbol "HBP". For more information, please visit www.helixbiopharma.com.
Forward-Looking Statements and Risks and Uncertainties
This News Release contains forward-looking statements and forward-looking information (collectively, "forward-looking statements"), within the meaning of applicable securities laws, regarding the Company's plans for the development of L-DOS47; its hope that the FDA approval process will be successful; L-DOS47 as an innovative cancer treatment for NSCLC; the Company's plans to commence human clinical testing of the drug candidate; its planned Phase I study, including study methodology, estimates regarding the number of patients and time frames; its planned Polish Phase I/II study; its priorities for capital resources; its need for additional capital; and other information in future periods. Although Helix 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. Certain material factors or assumptions which have been applied in making forward-looking statements, include, but are not limited to, assumptions regarding the safety and efficacy of Helix's drug candidates; the timely receipt of necessary regulatory approvals and appropriate financing; and that the Company's drug candidates will ultimately be successfully developed and commercialized. Important risk factors that could cause actual results to differ materially from these forward-looking statements include, without limitation, that the Company's assumptions may prove to be incorrect; the Company's continuing need for additional capital and for substantial funding beyond its current resources, which are not assured; that the FDA is not bound by any pre-IND meetings and may deny approval of the Company's IND or put the Company's IND application on clinical hold; insufficient or delayed patient enrolment for any of the planned studies; the risk that the design or duration, or both, of the planned clinical trial may be different than currently intended; uncertainty whether the Company's planned clinical trials referred to in this news release will be approved, conducted or achieve expected results; the need for further regulatory approvals, including marketing authorizations, which are not assured; the Company's dependence on performance by its third party providers of intellectual property, services and supplies, including without limitation, clinical trial services and supplies of drug product; the potential need for further clinical trials beyond those mentioned in this news release which may not occur as planned or achieve expected results; product liability and insurance risks; risks and uncertainties related to research and development, including clinical trial and manufacturing risks; intellectual property risks; uncertainties related to economic conditions; uncertainty whether L-DOS47 or Topical Interferon Alpha-2b will be successfully developed and commercialized; exchange rate risk; and the risk of changes in business strategy or development plans. Investors should consult the Company's quarterly and annual filings, including its latest Form 20-F, with the Canadian and U.S. securities commissions at www.sedar.com and at www.sec.gov for additional information on these and other risks and uncertainties which may affect the Company. Investors are cautioned against placing undue reliance on forward-looking statements. Forward-looking statements are based on the beliefs, assumptions, opinions and expectations of Helix's management at the time they are made, and Helix does not assume any obligation to update any forward-looking statement should those beliefs, assumptions, opinions or expectations change, except as required by securities law.