NOVEMBER 2023LIFE SCIENCES REVIEW 19We aspire to offer terminally ill patients not just treatment, but effective, evidence-backed solutions, delivering hope, pain relief and disease remissiontreatment options, it is validating their therapeutic use through the full spectrum of pre-clinical and first in human testing.To confirm crotoxin's safety and efficacy, the Celtic Biotech team commenced human Phase I trials in France with the approval of French clinical regulatory authorities. In part one of the trials, the drug indicated clear safety at low dose levels and physicians moved quickly to the second part of this innovative trial incorporating the use of higher escalating dosages. The safety profile of the drug was reaffirmed in the second part, with two out of six patients showing stabilisation in both primary and secondary tumors, while two others exhibited primary tumour stabilisation, all within 40 days, demonstrating crotoxin's potential efficacy even without establishing the maximum tolerated dose. Due to the pronounced safety profile, in addition to the suggestion of efficacy, the part 2 trial was also curtailed from the planned 12 patient recruitment in order to develop an upgraded part 3 protocol. This newer study will commence with higher doses, employing faster intra-patient dose ramping and extended treatment periods that is expected to provide greater indications of efficacy.Having received approval for this third and final part of its Phase I trial, the company plans to recruit 24 advanced stage patients with trial commencement mid-2024. The company's product pipeline has many innovative therapeutic candidates for various health conditions. CB-6, a drug derived from cobra venom, demonstrates an ability to enhance the efficacy of other anti-cancer and chemotherapeutic agents. It also shows promise in ameliorating chronic kidney disease, a condition that currently lacks significant treatment options for humans.Another drug, CTC-310, is a combination product comprising CB-24 and CB-6. In animal models, it exhibits positive responses in terms of growth inhibition, laying the groundwork for potential Phase II clinical trials in specific cancers like pancreatic and colon.Next in line is the CB-CDV drug. Originally used to treat epilepsy in the early 1900s, it shows promise against benign and malignant brain cancers. Its initial application is expected to be applied to melanomas.Joining the line-up is CB-5, a novel drug for cancer and gene therapy. These peptide-based membrane interactive compounds offer an effective mechanism of action distinct from conventional chemotherapy. As a protein, its novelty extends to its effectiveness in animals models when administered by mouth.Distinguished with a combination of promising therapeutic products and a steadfast commitment to the welfare of terminally ill patients, Celtic Biotech is driven to embrace innovation, new challenges, and explore novel approaches as it sprints towards the goal of revolutionizing treatments for cancer, pain, and chronic health conditions.
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