Helix Biopharma Signs L-DOS47 Manufacturing Agreement With BioVectra DCL
AURORA, ON, Jan. 5 /PRNewswire-FirstCall/ - Helix BioPharma Corp. announced today that it has signed an agreement with BioVectra, a division of Diagnostic Chemicals Limited ("BioVectra dcl"), to manufacture L-DOS47 bulk drug product for human clinical testing.
"The signing of this agreement builds upon previous manufacturing work through which fundamental cGMP processing parameters for L-DOS47 have been developed," said John Docherty, Helix's Vice President of Corporate Development. "BioVectra dcl is a natural choice for our clinical manufacturing program requirements because in addition to their high calibre capabilities in the cGMP production of biopharmaceuticals, they are also one of the largest North American producers of the urease substance at the heart of our L-DOS47 drug product."
During 2007, Helix intends to continue to work diligently on completing the remaining preclinical animal testing work with L-DOS47, in parallel with finalizing its clinical manufacturing activities. In working to complete this program, Helix is focused on its path toward pursuing the necessary regulatory authorizations thereafter to conduct a Phase I clinical trial with L-DOS47 in patients with adenocarcinoma of the lung.
L-DOS47 combines Helix's proprietary DOS47 new drug candidate with a highly specific single domain antibody to form a potential new targeted drug product for the treatment of adenocarcinoma of the lung, the most common form of cancer in the world today. L-DOS47 is thought 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 doing so at the site of cancerous tissues in the body, L-DOS47 is believed to modify the microenvironmental conditions of lung 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.
BioVectra, a division of Diagnostic Chemicals Limited, is a Canadian manufacturer of active pharmaceutical ingredients, bulk drug products and chemical intermediates with over 35 years of experience serving a global customer base. BioVectra dcl provides small to large scale custom manufacturing of active pharmaceutical ingredients, bulk drug products and chemical intermediates along with a complement of core products targeted towards bioprocessing. BioVectra dcl operates three FDA-inspected facilities that are equipped to provide a range of contract services for its clients. More information can be obtained from www.biovectra.com.
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 Topical Interferon Alpha-2b and its novel L-DOS47 new drug candidate. Helix is listed on the TSX under the symbol "HBP".
The Toronto and Frankfurt Stock Exchanges have not reviewed and do not accept responsibility for the adequacy or accuracy of the content of this News Release. Helix BioPharma Corp. ("Helix" or the "Company") has relied solely on BioVectra dcl for the information about BioVectra dcl provided in this News Release and the Company disclaims any liability with respect to such information. Helix disclaims responsibility for information contained in any linked or referenced website, and such links and references do not constitute an endorsement by Helix of those or any other website. This News Release contains certain forward-looking statements regarding the Company's planned development of L-DOS47, which statements can be identified by the use of forward-looking terminology such as "moving forward", "will", "finalizing", "to complete", "toward pursuing", "developing", or comparable terminology referring to future events or results. Forward-looking statements are statements about the future and are inherently uncertain, and Helix's actual results could differ materially from those anticipated in these forward-looking statements as a result of numerous factors, including without limitation, uncertainty whether DOS47 or L-DOS47 will be successfully developed as a drug or otherwise commercialized; the need for additional research and development, the outcome of which is uncertain; the need for clinical trials, the occurrence and success of which cannot be assured; product liability and insurance risks; the risk of technical obsolescence; the need for regulatory approvals, which may not be obtained in a timely matter or at all; intellectual property risks; marketing/manufacturing and partnership/strategic alliance risks, and in particular, the need for performance by BioVectra dcl; the effect of competition; Helix's need for additional future capital, which may not be available in a timely manner or at all; as well as a description of other risks and uncertainties affecting Helix and its business, as contained in Helix's latest Annual Information Form and other news releases and filings filed on SEDAR at www.sedar.com, any of which could cause actual results to vary materially from current results or Helix's anticipated future results. Forward-looking statements are based on the beliefs, 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, opinions or expectations, or other circumstances change.Helix BioPharma Corp.
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