ValiSeek has received notification of acceptance by all of the required regulatory authorities in the republic of Georgia of the protocol and associated documentation for the Phase IIb clinical trial of VAL401 at a clinic in Tbilisi.
The full title of the trial is: "A Phase II study to assess the efficacy, safety and tolerability of VAL401 in the treatment of patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) after failure of at least one prior chemotherapeutic regimen".
The all-clear allows ValiSeek to complete initiation of the clinical site at the Medulla Immunotherapy and Chemotherapy Clinic and allows principle investigator Dr Tsira Kortua to begin identifying patients to be recruited into screening.
In all, no more than 20 patients will be enrolled in the tests, which will be carried out on each patient over a period of six months, though recruitment will be done in phases to ensure patient safety.
The approved protocol lists "tumour progression-free survival" as the primary end-point of the trial. This will record the length of time between patient screening and progression of the disease, providing a first indication of whether the treatment will be efficacious, ValiRx said.
Secondary end-points include drug absorption (pharmacokinetic) measurements; safety and tolerability of the drug; quality of life of the patients and overall survival, providing supporting data on efficacy and drug dosing parameters, which are key to aligning the programme with industry expectations.
"It is very satisfying to have received confirmation from the regulatory experts that the trial has been correctly constructed and that the process of selecting patients for dosing can begin. After several years of preparation and pre-clinical testing, it is exciting to know that we can expect results to start arriving in the coming months," said Dr Suzanne Dilly, chief executive officer of ValiSeek.
Dr Satu Vainikka, chief executive officer of ValiRx, echoed her colleague’s sentiments.
"We at ValiRx are absolutely thrilled to get this approval for our VAL401 treatment to go to late stage clinical trial for this desperate unmet medical need," she said.
Shares in ValiRx rose 9.7% to 8.5p in the first half hour of trading on the news.
ValiSeek was formed to progress the novel cancer treatment drug, VAL401, towards clinical efficacy trials for the treatment of lung cancer and other oncology indications.
"This is a significant step and a major milestone in the process for the VAL401 project," said Northland Capital Partners.
The shares rose 4.5% to 8.1p.
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