Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Helix BioPharma has announced the recent submission of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for approval to initiate a Phase I clinical trial with L-DOS47.
Subscribe to our email newsletter
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.