March's top stories: Cancer Research UK's pancreatic cancer trials, Novartis' Cosentyx in psoriasis
Cancer Research UK invested £10m in the PRECISION Panc project, including a network of clinical trials for the treatment of pancreatic cancer, and Novartis reported positive results from the extension A2302E1 trial of Cosentyx to modify the course of psoriasis. Drugdevelopment-technology.com wraps up the key headlines from March.
Cancer Research UK invested £10m in the PRECISION Panc project, designed to include a network of clinical trials for the treatment of pancreatic cancer.
The PRECISION Panc project is a research programme to develop personalised treatments for the patients, providing options and outcomes for better survival.
The programme will include three trials and enrol a total of 658 patients from a number of centres across the UK.
Swiss-based healthcare company Novartis reported positive results from the extension A2302E1 trial of Cosentyx (secukinumab), indicating the product's ability to modify the course of moderate-to-severe psoriasis with long-term and treatment-free skin clearance.
Cosentyx is a fully human, specific inhibitor of the IL-17A cytokine and is claimed to be the first and only inhibitor to have such an effect on the disease.
In the A2302E1 trial, patients were randomised to either continuous treatment or treatment cessation until relapse, after one year of treatment with the product.
St George’s University of London began a clinical trial of common malaria drug artesunate, priced at 70p, for the treatment of cancer.
The ability of artesunate to decrease the multiplication of tumour cells, as well as the risk of cancer spreading or recurring after surgery, will be studied during the trial.
The trial is to be conducted in collaboration with St George’s Hospital and the university raised more than £50,000 through a crowdfunding campaign to fund the second part.
German pharmaceutical firm Boehringer Ingelheim began patient enrolment in the Phase III clinical trial of nintedanib (OFEV) to treat progressive fibrosing interstital lung disease (PF-ILD).
Nintedanib targets growth factor receptors known to be involved in the pulmonary fibrosis mechanisms, and also blocks the signalling pathways associated with fibrotic processes to slow the decline in lung function.
The double-blind, randomised, placebo-controlled Phase III trial will enrol a total of 600 patients with different fibrosing lung diseases.
A clinical trial conducted by the Massachusetts General Hospital Cancer Center, US, demonstrated that the antibody-drug conjugate sacituzumab govitecan (IMMU-132) can target cancer cells and shrink tumours in women with triple negative breast cancer (TNBC).
Developed by fusing a chemotherapy treatment to an antibody, the drug targets Trop-2 that is reported to be found at high levels on the surface of several cancer cells, to selectively deliver the active metabolite of irinotecan called SN-38.
It was found that the sacituzumab govitecan was well tolerated, and triggered early and durable responses in heavily pretreated patients.
AstraZeneca's Lynparza (olaparib) met its primary endpoint in the Phase III SOLO-2 clinical trial for the treatment of patients with germline BRCA-mutated (gBRCA), platinum-sensitive, relapsed ovarian cancer patients.
Lynparza is a first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor designed to target tumour DNA damage response (DDR) pathway deficiencies to potentially destroy cancer cells.
The trial's primary endpoint was measured as progression-free survival (PFS) by blinded independent central review (BICR) evaluation.
Norwegian-based Nordic Nanovector began dosing patients in a Phase I clinical trial (LYMRIT 37-05) of Betalutin (177Lu-satetraxetan-lilotomab) to treat diffuse large B-cell lymphoma (DLBCL).
Betalutin is a CD37 targeting, antibody-radionuclide conjugate (ARC) being developed to complement the existing treatments for non-hodgkin lymphoma (NHL).
It consists of a tumour-seeking anti-CD37 antibody conjugated to a low intensity radionuclide known as Lutetium 177.
Cancer charity Myeloma UK and biotechnolgy firm Oncolytics Biotech commenced a Phase Ib MUK eleven trial of Reolysin (pelareorep) in combination with Imnovid (pomalidomide) or Revlimid (lenalidomide) to treat patients with relapsing myeloma.
Reolysin is Oncolytics' proprietary variant of the respiratory enteric orphan virus (reovirus), while Imnovid and Revlimid are Celgene's immunomodulatory drugs (IMiDs).
The dose escalation Phase Ib trial will evaluate the safety and tolerability of the combinations in patients whose myeloma is progressing while on these IMiD treatments.
Japanese-based pharmaceutical firm Daiichi Sankyo began enrolment in the Phase IIIb ENTRUST-AF PCI clinical trial of edoxaban for the treatment of atrial fibrillation patients who have undergone percutaneous coronary intervention (PCI) with stent placement.
Edoxaban is an oral, once-daily, direct factor Xa inhibitor designed to make the blood thin and minimise its clotting.
The firm plans to enrol 1,500 patients from 200 clinical sites across countries such as Europe, Korea, Taiwan and Ukraine.
Clinical research solutions provider Celerion deployed the Verified Clinical Trials (VCT) biometric fingerprint technology to prevent dual enrolment in clinical trials.
The technology utilises a fingerprint biometrics and ID metric hybrid process to avoid simultaneous multiple clinical drug trial enrolment or premature re-enrolment into another study.
VCT also provides a HIPAA compliant research subject clinical trials database registry to improve both patient safety and preserve data integrity in clinical trials.