ValiRx Plc
("ValiRx" or "the Company")
QUARTERLY UPDATE ON CLINICAL PROGRESS
First readout from VAL201 Clinical Trial
London, UK, 9th February 2016: ValiRx Plc (AIM: VAL), a life science company with a focus on cancer diagnostics and therapeutics for personalised medicine, provides a quarterly update on clinical progress.
VAL201
Following on from the Company's update on 19 November 2015 regarding its Phase l/ll Clinical Trial of VAL201 and its application to subjects with hormone resistant prostate cancer, ValiRx confirms that the compound is well tolerated up to a putative therapeutic dose and that it has shown a high degree of safety, with no drug related significant adverse events being reported. The Company is pleased that the readout from the first part of the trial - from first in human dosing though to a therapeutically meaningful dose - has shown such strong safety and tolerability in all trial subjects. ValiRx is also happy to advise that other measurements taken are completely consistent and comparable to the results seen in the pre-clinical studies, both in vivo and in vitro, that completed prior to this early Human phase of development in which efficacy was shown. The trial also permits investigation of other solid hormone resistant tumour types.
The additional Clinical Trial Centres mentioned in the previous update are being integrated into the study to assist with the dose expansion stage of the trial, in which strengthening of the dosing, safety and tolerability data will continue while further aspects of VAL201 anti-tumour activity are investigated. The additional capacity this represents will help ensure trial completion according to the expected timetable. Currently, further cohorts of subjects are being recruited as the dose expansion phase completes.
In light of the excellent results shown by the compound with respect to tolerability and safety in the current clinical trial, along with promising pre-clinical evidence of the compounds efficacy with respect to the treatment of endometriosis, the Company has started the design of the protocol to test VAL201 for its in-human potential in the treatment of the debilitating female condition of Endometriosis*. ValiRx has already shown good pre-clinical results for this indication.
VAL401
The Company's VAL401 trial, (namely VAL401-001: "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") has been registered with the European Union Drug Regulating Authorities Clinical Trials Database (EudraCT). Work is now continuing to advance the regulatory approval process, with a primary trial site and Principal Investigator successfully identified and engaged.
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For more information, please contact:
Cairn Financial Advisers LLP (Nominated Adviser) |
Tel: +44 (0) 20 7148 7900 |
Liam Murray / Avi Robinson |
|
Northland Capital Partners Limited (Broker) |
Tel: +44 (0) 20 7382 1100 |
Patrick Claridge / David Hignell (Corporate Finance) John Howes / Abigail Wayne (Broking) |
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* About Endometriosis
Endometriosis is a gynaecological medical condition in which cells from the lining of the uterus (endometrium) appear and flourish outside the uterine cavity, most commonly on the ovaries. The uterine cavity is lined by endometrial cells, which are under the influence of female hormones. These endometrial-like cells in areas outside the uterus (endometriosis) are influenced by hormonal changes and respond in a way that is similar to the cells found inside the uterus. Symptoms often worsen with the menstrual cycle. Endometriosis is excessively debilitating, typically seen during the reproductive years and represents one of the major causes of female infertility.
It has been predicted that the global endometriosis market will reach $1.3billion by 2017 and endometriosis remains a common health problem among women, with an estimated 170 million sufferers globally. This estimate is widely considered to be an under estimation of the true situation with respect to this condition.
About ValiRx Plc
ValiRx Plc is a biopharmaceutical company developing novel technologies and products in oncology therapeutics and diagnostics. The product focus is in the epigenomic analysis and treatment of cancer, but the technologies can be applied to other fields as well, such as neurology and inflammatory diseases.
The Company listed on the Alternative Investment Market ("AIM") of the London Stock Exchange in October 2006.
The Company has a pipeline of other therapeutic drugs, which are currently progressing towards clinical trials. The product focus is in the targeted analysis and treatment of cancer, but the technologies can be applied to other fields as well, such as neurology and inflammatory diseases. It actively manages projects within its portfolio as a trading company. The ValiRx business model spreads the risks of life science technology development by minimizing financial exposure and running a set of projects to defined commercial endpoints. This maximizes returns to shareholders by adding value at the earlier stages where value increases per investment unit are the greatest.
The Company operates through the following divisional companies:
1. ValiPharma is the therapeutics division, with two embedded technologies primarily directed at the treatment of cancers.
2. ValiFinn is the biomarkers and diagnostic development division. ValiRx acquired through its ValiFinn subsidiary, the complimentary TRAC technology to strengthen the portfolio.
3. ValiSeek is a joint venture between ValiRx and Tangent Ltd to develop Val401 in lung cancer and potentially other indications.
