(Alliance News) - Faron Pharmaceuticals Oy said on Friday its MATINS study of nine cancer patients is progressing well, and it is planning to expand the clinical trial to more countries. The clinical stage drug developer is undertaking the trial to investigate the safety and effectiveness of Clevegen, the company's cancer immunotherapy. Faron reached its planned Clevegen dosing of 10 milligrams per kilogram in June and said this was "well tolerated" by patients. It plans to propose an increase of the test dosage to 20 milligrams per kilogram to the trial's independent data monitoring board. The MATINS study is investigating five cancers: cutaneous melanoma, hepatobiliary, pancreatic, ovarian and colorectal. Altogether these cancers have two million annual cases worldwide.
Of the nine patients being studied across three clinical sites in the UK and Finland, two subjects have demonstrated anti-cancer responses.
One patient with colorectal cancer showed a shrinking of lung metastasis, which is when cancerous cells from other parts of the body spread to the lungs. Another subject with colorectal cancer showed signs that their tumours were stabilised. Faron has also filed a pre-investigational new drug application with the US Food & Drug Administration which if approved, could allow the company to open new sites in the country and expand its colorectal cancer cohort. The company hopes to expand clinical development plans by including cancer centres in Spain and France as the next countries in Europe to join the MATINS trial.
Shares in Faron rose 18% at 138.52 pence each in London on Friday morning.
Faron Pharmaceuticals hailed the progress of its clinical study over the last few months which indicated potential early efficacy and good tolerability for its cancer treatment.
The company said it expected to progress the cohort expansion phase of the study in the third quarter of 2019 in patients with late-stage colorectal cancer. With more data generated, we will 'seek guidance from regulators regarding the best and fastest pathway to secure initial approval of Clevegen as a single-agent treatment,' it added.
The latest data from the open label phase I/II MATINS clinical trial investigated the safety and efficacy of Clevegen, Faron's wholly-owned novel precision cancer immunotherapy, in selected metastatic or inoperable solid tumours.
The company also said it hoped to conclude partnering talks during the second half of the year, paving the way to expand clinical development to include combination studies exploring the potential of Clevegen in combination with existing immunotherapies.
Indivior closed up 6.7% after the opioid addiction treatment producer revised its expectations for 2019 net revenue and net income higher following a stronger-than-expected first half.
Indivior also said its own case with the US DoJ is separate from that of its former parent company.In April, the DoJ charged the drugmaker with using a fraudulent marketing scheme to boost prescriptions of its flagship opioid addiction treatments, causing the stock to plummet