Helix BioPharma Corp, a biopharmaceutical company developing innovative drug candidates for the prevention and treatment of cancer, has received approval from the US Food and Drug Administration, to initiate a phase I clinical trial with L-DOS47.
The study is entitled “A phase I, Open Label, Dose Escalation Study of Immunoconjugate LDOS47 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”.
The study is designed as a dose-escalation cohort study in first-line lung cancer patients. Patients will receive L-DOS47 in combination with standard chemotherapy of pemetrexed/carboplatin. Based on the ongoing review of safety data from study LDOS002 being conducted in Poland, the recommended starting dose of L-DOS47 is 0.59 µg/kg, and dose will be escalated upon review of each cohort by the Safety Steering Committee. Once maximum tolerated dose (“MTD”) is reached, up to an additional 10 patients will be recruited to evaluate overall response rates.
“We are pleased with this approval to begin the next steps of our clinical development plan” said Robert Verhagen, president and chief executive officer, of Helix. “Our goal for L-DOS47 is to identify the best possible use of this drug candidate in combination with other chemotherapeutic and targeted agents. We believe that L-DOS47 has the potential for real value in additive or synergistic
combinations with currently marketed therapies. This trial, once funded and initiated, will be the first step towards realising that value in patients undergoing first line therapy.”
The study is designed as a dose-escalation study in first-line Non-Small Cell Lung Cancer patients.Patients will be recruited into cohorts, with a minimum of 3 and a maximum of 6 patients per cohort. Based on the ongoing review of safety data from study LDOS002, the recommended starting dose of L-DOS47 is 0.59 µg/kg.
Patients will receive L-DOS47 in combination with standard chemotherapy of pemetrexed/carboplatin, and dose will be escalated upon review by the Safety Steering Committee. Once MTD is reached, up to an additional 10 patients will be recruited to evaluate overall response rates.
Patients will receive up to four cycles of the combination treatment. Patients who have not progressed following the 4 cycles of combination treatment and who have not experienced unacceptable toxicity will have the opportunity to continue to receive additional cycles of L-DOS47 treatment for as long as there is clinical benefit and it is well-tolerated.