AURORA, Canada I May 14, 2012 I Helix BioPharma Corp. (HBP.TO) (HBP) (HBP.F), a developer of biopharmaceutical drug candidates for the prevention and treatment of cancer, today announced that clinical site initiation and patient recruitment activities in its Phase I/II clinical safety, tolerability and preliminary efficacy study of L-DOS47 have commenced in Poland.

"This Phase I/II open-label, non-randomized dose escalation study in patients with non-squamous, non-small cell lung cancer represents the foray into clinical testing for our novel L-DOS47 immunoconjugate therapy," said Prof. Kazimierz Roszkowski-Śliż MD, Ph.D., Helix’s European Medical Director and Director and Head of the Clinical Department of the National Tuberculosis and Lung Diseases Research Institute in Warsaw. "The potential benefits to sufferers of this aggressive cancer are significant and I am hopeful for its success."

"Starting this clinical trial for L-DOS47 is a major milestone for Helix," said Dr. Heman Chao, Chief Scientific Officer of Helix BioPharma Corp. "It represents the fruition of an idea for the DOS47 technology that was born within Helix. I look forward to a positive outcome from this trial to demonstrate the potential benefits to patients and validate DOS47 as a possible platform for other new DOS47-based therapeutics in Helix’s research pipeline."

L-DOS47 is Helix’s first drug candidate in development based upon the Company’s 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 an immunoconjugate-based drug intended to offer an innovative approach to the first-line treatment of inoperable, locally advanced, recurrent or metastatic, non-small cell lung cancer.

The study will be conducted at four Polish centers under the direction of Prof. Maciej Krzakowski, MD, PhD at The Maria Sklodowska-Curie Memorial Cancer Centre & Institute of Oncology as the overall coordinating investigator, together with three 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 and Dr. Aleksandra Szczensa, MD, PhD at the Mazovian Center of Pulmonary Diseases and Tuberculosis in Otwock. 

SOURCE: Helix BioPharma