Pharmaceutical Business review

Helix BioPharma submits L-DOS47 IND application with FDA

The study is entitled ‘A Phase I, Open Label, Dose Escalation Study of Immunoconjugate L-DOS47 in Combination with Standard Doublet Therapy of Pemetrexed/Carboplatin in Patients with Stage IV (TNM M1a and M1b) Recurrent or Metastatic Non-Squamous Non-Small Cell Lung Cancer’ (NSCLC).

Helix president and CEO Robert Verhagen noted that this is a very positive step forward in the development of L-DOS47.

"While our Polish Study will provide vital information on our candidate as a monotherapy, our goal for this study, if approved by the FDA, will be to understand how L-DOS47 will work in combination with other chemotherapeutic agents," Verhagen added.

L-DOS47 is Helix’s first immunoconjugate-based drug candidate in development based upon the Company’s novel DOS47 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.

L-DOS47 is currently being clinically evaluated as a treatment for certain patients with non-small cell lung cancer.