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news.Helix BioPharma announced the recommendation by the Trial Steering Committee to initiate the Phase II component of the LDOS002 study.
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"We have now determined the Phase II dose and monotherapy regimen of L-DOS47 for patients that have limited treatment options in our LDOS002 study," said Mr. Steve Demas, the newly appointed Chief Medical Officer of Helix. Up to forty-five (45) patients will be enrolled in the Phase II open-label, non-randomized study designed to make a preliminary assessment of efficacy of L-DOS47 in patients with non-squamous non-small cell lung cancer ("NSCLC").
"Advancing our lead product candidate into Phase II is an important milestone for the Company." said Dr. Sven Rohmann, Chief Executive Officer of Helix.
"In addition, we are currently evaluating the safety of L-DOS47 in combination with pemetrexed/carboplatin in the U.S. and are planning to investigate the efficacy of L-DOS47 in combined modality with other chemo- and/or immuno-therapies."
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.
About L-DOS47 clinical development
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L-DOS47 is currently being clinically evaluated in two clinical studies, in Poland and in the United States, as a treatment for certain patients with NSCLC.
LDOS002 is an open-label Phase I/II clinical study to evaluate the safety, tolerability and preliminary efficacy of ascending doses of L-DOS47, initially as a monotherapy, in patients with inoperable, locally advanced, recurrent or metastatic, non-squamous, stage IIIb/IV NSCLC. The study is being conducted at five Polish centers: the Maria Sklodowska-Curie Memorial Cancer Centre & Institute of Oncology, the Military Medical Institute, the National Tuberculosis and Lung Diseases Research Institute, the Mazovian Center of Pulmonary Diseases and Tuberculosis in Otwock and the Department of Oncology, Poznan University of Medical Science.
On September 8th, 2015, the company presented results from the ongoing LDOS002 study at the 16th World Conference on Lung Cancer held in Denver, Colorado. Results from patients enrolled in the first twelve dosing cohorts included:
L-DOS47 was well tolerated at dose levels studied to-date;
Twenty-one (21) of the 40 patients enrolled (52%) had an overall response of ‘stable disease’ after completion of two cycles of L-DOS47;
Eleven (11) of the 21 patients had a response of ‘stable disease’ after completing four cycles of L-DOS47;
One (1) patient in the 9th dosing cohort (1.84µg/kg) was dosed for 10 cycles (approximately 7 months) without disease progression.
LDOS001 is a Phase I, open-label, dose escalation study being conducted in the U.S. at three centers: The University of Texas, M.D. Anderson Cancer Centre, Penn State Milton S. Hershey Medical Center; and University Hospitals Case Medical Center. The primary objective of the study is to determine the safety and tolerability of L-DOS47 in combination treatment with pemetrexed/ carboplatin.
On March 3rd, 2016, the company reported on the progress of study LDOS001. A patient in the first dosing cohort received four cycles of L-DOS47 in combination with pemetrexed/carboplatin and an additional four cycles of L-DOS47 alone before progression of their disease. The best response reported for this patient was a 37% decrease in the sum of the diameters of target lesions identified at baseline.