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Helix BioPharma Corp. Commences L-DOS47 Phase lb/ll Pancreatic Cancer Clinical Study

RICHMOND HILL, Ontario, Dec. 11, 2019 (GLOBE NEWSWIRE) -- Helix BioPharma Corp. (TSX: HBP), (FSE: HBP) (“Helix” or the “Company”), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, today announced the start of enrollment and screening in the Company’s Phase lb/ll clinical development program for previously treated patients with advanced pancreatic cancer.

The study is entitled “A Phase Ib/II Study of the Microenvironment Modifier L-DOS47 plus Doxorubicin for the Treatment of Patients with Previously Treated Advanced Pancreatic Cancer”.  The Phase Ib portion of the study involves three dose escalating cohorts enrolling a total of nine (9) patients.  The Phase II portion of the study will enroll an additional eleven (11) patients depending on meeting safety and efficacy criteria.  The principal investigator of the study is Dr. Erkut Borazanci.  The study center is located in Scottsdale, Arizona at the Scottsdale Hospital dba HonorHealth. 

Pancreatic cancer is the third leading cause of cancer death in the United States for which there are few treatment options.  L-DOS47 with its novel mechanism of action aims to transform the treatment landscape by combatting the acidic tumor microenvironment, which is hostile to the body’s immune system.

“I would like to personally thank Dr. Daniel Von Hoff in helping us develop this clinical study,” said Dr. Heman Chao, Helix’s Chief Executive Officer.  “We are very excited to expand our clinical drug development program to include this new indication.  With excellent safety and tolerability data already obtained from a monotherapy study in late stage non-small cell lung cancer and ongoing combination studies in similar patient groups, this new clinical study will add to the expanding utility of L-DOS47 in multiple cancer indications.”

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 and Chimeric Antigen Receptor (“CAR”) based cell therapies. Helix is currently listed on the TSX under the symbol “HBP”.

About DOS47
DOS47 is based upon a naturally occurring enzyme isolated from the jack-bean plant called urease that breaks down a natural substance found in the body, urea, into metabolites that include ammonia and hydroxyl ions.  By doing so at the site of cancerous tissues in the body, the Company believes DOS47 can modify the micro environmental conditions of cancerous cells in a manner that leads to apoptosis.  DOS47 stimulates an increase in the pH of the microenvironment surrounding the cancerous cells, effectively reversing the acidic extra-cellular conditions that are believed to act to defend tumour cells.

About L-DOS47
L-DOS47 is Helix's first immunoconjugate based drug candidate in development based on the Company’s novel DOS47 platform 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.

Investor Relations
Helix BioPharma Corp.
9120 Leslie Street, Suite 205
Richmond Hill, Ontario, L4B 3J9
Tel: 905-841-2300

Cautionary Statements
This news release may contain forward-looking statements with respect to Helix, its operations, strategy, financial performance and condition, including its activities relating to its drug development program, any anticipated timelines for the commencement or completion of certain activities such as raising sufficient capital, merger and acquisition activity, listing on a U.S. exchange and other information in future periods. These statements generally can be identified by use of forward-looking words such as “aims”, “transform”, “should”, “may”, “will”, “expect”, “estimate”, “anticipate”, “intends”, “believe” or “continue” or the negative thereof or similar variations. The actual results and performance of discussed herein could differ materially from those expressed or implied by such statements. Such statements are qualified in their entirety by the inherent risks and uncertainties surrounding future expectations, including: (i) Helix’s ability to operate as a going concern being dependent mainly on securing sufficient additional financing in order to fund its ongoing research and development and other operating activities; (ii) the generally inherent uncertainty involved in scientific research and drug development and those specific to Helix’s pre-clinical and clinical development programs (DOS47, L-DOS47, V-DOS47 and CAR-T); (iii) that any transactions contemplated herein are completed; and (iv) those risks and uncertainties affecting Helix as more fully described in Helix’s most recent Annual Information Form, which is available at (together, the “Helix Risk Factors”). Certain material factors and assumptions are applied in making the forward-looking statements, including, without limitation, that sufficient financing will be obtained in a timely manner to allow Helix to continue operations and implement its clinical trials in the manner and on the timelines anticipated and 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, opinions, plans 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, plans or expectations, or other circumstances change, except as required by law.


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