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NAV3 Biomarker Patent Granted in Australia
5 December 2013
ValiRx Plc announces a new patent grant for their NAV3 gene biomarker - the company's method for cancer screening. The use of biomarkers enables improved therapeutic targetting, lowering the potential cost and extending the potential reach of life saving cancer therapies.
Read full release here.
VAL201 - Update
24 October 2013
ValiRx Plc (AIM: VAL), a life science company with a focus on cancer therapeutics for personalised medicine, is pleased to report that the Clinical Trial Project Team (“Project Team”) which comprises independent experts in the various disciplines covering all aspects of the study for VAL201, ValiRx’s leading anti-cancer therapeutic, has signed off on the protocol for its enhanced Phase 1b trial which is expected to advance to a Phase 2 study.
The additional information required for the expanded Final Trial Management documentation, including the Investigational Brochure, the Investigational Medicinal Product Dossier and Clinical Trial Application for the new trial, are now being completed so that all remaining permissions and approvals are obtained for this trial to commence in Q1 2014. The expanded trial is anticipated to yield early results within 8 weeks of commencement.
Originally, and as previously announced, a First in Human Phase 1 trial to merely demonstrate safety had been contemplated. However, during the clinical development process the original study concept has been expanded into a significantly more comprehensive Phase 1b trial, which, in addition to establishing the safety of VAL201, the trial will now also provide an initial measure of VAL201’s efficacy in the treatment of patients with prostate cancer as well as patients with other solid tumors.
This more comprehensive trial will now supersede the original trial concept. These changes follow advice and recommendations from the Company, its advisors and independent experts as well as the Medicines and Healthcare Products Regulatory Agency and from University College London Hospital, the clinical trial centre.
Although the scope of the trial has been expanded, the Company has sufficient funds to fulfill the aim of the original First-in-Man Phase 1 trial announced last year, which focused exclusively on demonstrating safety, and now represents only a part of the expanded trial.
While the results of this trial will come later than the projected timeline for the original First in Human Phase 1 trial, we anticipate that the revised strategy will accelerate VAL201’s clinical programme to Phase 2a and 2b studies, which are key value inflection points, and lead to time and cost savings alongside generating greater value.
Dr Satu Vainikka, Chief Executive, commented: “With the support of members of the Clinical Trial Project Team, in particular the Principal Investigators, we have arrived at a trial protocol that will provide considerably more clinical data on VAL201 than originally planned. Our expectation is that demonstrating VAL201’s safety and obtaining a measure of its efficacy in the same study will not only hasten the drug’s clinical development but will also raise shareholder value. The extra information provided by this study will moreover make the product more attractive to potential partners”
VAL201 - Filing of Phase IB Clinical Trial to be undertaken at University College London Hospital “(UCLH”)
3 October 2013
ValiRx Plc (AIM: VAL), a life science company with a focus on cancer therapeutics for personalised medicine, is pleased to announce that the Company has filed a Phase IB/dose escalation study (“Trial”) for VAL201, ValiRx’s leading anti-cancer therapeutic. This represents an ethical and Research & Development committee filing that is needed before approval to proceed in cancer cases is granted. The Trial will be directly a First in Man with real patients and will not require healthy volunteers. Therefore the Company expects to obtain significant results rapidly.
The clinical unit at University College London Hospital “(UCLH”) is being contracted to undertake the Human work for this Trial. The Trial protocol and associated scientific information have been submitted to UCLH for consideration by their ethical and research committees, leading to their permission for ValiRx to use their facilities for the Human portion of the Trial.
The Trial, is to be conducted using prostate cancer patients and it is expected that the Trial will provide data on both its primary and secondary objectives, which are (i) to determine the maximum dose comparable with the safety and tolerability of VAL201; and (ii) to study the biochemical and physiological effects of VAL201 in relation to concentration and effect and make a preliminary assessment of anti-tumour activity. The intention is that the Trial should allow quick progress to a full efficacy or Phase II study.
The Board believes the protocol will deliver information on the safety profile of the compound and an indication of its efficacy in patients in as timely and economically efficient a manner as possible. The trial design is significantly more comprehensive and all encompassing than was originally conceived and submitted at the start of the clinical development phase and before to the Company’s scientific meeting with the Medicines and Healthcare Products Regulatory Agency (“MHRA”).
The supporting background scientific work has been completed and the required ancillary analytical methods and procedures have now been established and are in place to complete the Human portion of the Trial.
Dr Satu Vainikka, Chief Executive, commented: “I am delighted with the progress of our compound and with all the hard work from the team to get VAL201 into first-in-man trials. I look forward to its further progress and development and to the compound’s future potential as a life-saving treatment against a number of cancers”.
The study Protocol is entitled: A Phase 1b, Dose Escalation Study to Assess the Safety and Tolerability of VAL201 in Patients with Locally Advanced or Metastatic Prostate Cancer and Other Advanced Solid Tumours.
Consortium including ValiRx Awarded New Eurostars Grant
16 September 2013
ValiRx Plc (AIM: VAL), a life science company with a focus on cancer therapeutics for personalised medicine, is pleased to announce that the consortium, which comprises ValiRx and Pharmatest Services Limited has been awarded a prestigious new Eurostars grant.
The grant to the consortium is for up to €1.6 million and the funds will be used to progress the pre- clinical studies of VAL101, the Company’s lead candidate deriving from the GeneICE platform and to build the associated cancer models. Additionally, some funding is for further GeneICE compounds directed at known Cancer targets.
This award follows the previous Eurostars grant of €1.4 million, the programme in respect of which was completed earlier this year and was accepted by both the Technology Strategy Board (TSB) and the Eurostars Team, as reported on 31 July 2013.
Dr Satu Vainikka, Chief Executive, commented: “I am delighted to see and grateful for continued support from the Eurostars programme. Their grant will substantially help progress our work on VAL101 and GeneICE, which will in turn we believe, build value”.
For more information, please contact:
Tel: +44 (0) 20 3008 4416
Dr Satu Vainikka
Cairn Financial Advisers LLP (Nominated Adviser)
Tel:+44 (0) 20 7148 7900 Liam Murray / Avi Robinson
Hybridan LLP (Broker)
Tel: +44 (0) 20 7947 4350 / 4361
Claire Louise Noyce / William Lynne
Tel: +44 (0)7879 458 364
ValiRx Plc - Interim Results For The Six Months Ended June 2013
15 September 2013
Half Yearly Report
ValiRx Plc (AIM: VAL), a life science company with a focus on cancer diagnostics and personalised therapeutic development announces its unaudited results for the half year ended 30 June 2013.
- Revenues for the half-year - £103,999 (2012: £157,535);
- Administrative expenses - £683,593 (2012: £709,148);
- Loss after taxation - £1,497,699 (2012: loss £1,088,122) reflecting an increased expenditure of £972,219 (2012: £540,211) being spent during the half-year on Research and Development;
- Development programmes across the Group are progressing well on all fronts and these include ValiRx’s leading anti-cancer therapeutic VAL201; its first GeneICE-derived compound VAL101 and Biomarker development to complement the Company’s therapeutics;
- VAL201 continues to progress in a “First-in-(Hu)Man study” Phase I trial involving cancer patients – results anticipated before the end of 2013;
- VAL101 continues to show good progress in the pre-clinical phase – the programme is to benefit from a second Eurostars grant for up to €1.6 million;
- Biomarker development programme, to support clinical and pre-clinical development, is progressing well and producing preliminary results. The programme is supported extensively by Finnish Government regional funding; and
- Appointment of Dr. Alan Boyd as Medical Monitoring Officer to oversee VAL201 clinical development and further collaboration with internationally respected centres of excellence.
Nicholas Thorniley, Non-Executive Chairman of ValiRx, commented:
“The Company has made some very encouraging progress over the past half year with some excellent advances in our clinical and pre-clinical development pipeline. We have also taken the opportunity of further establishing the Group’s scientific base with internationally respected advisers
and research partners. These steps forward permit your Company an increasingly confident perspective and I also look forward to reporting on the results of our clinical trial, which are anticipated in late December 2013”.
- ENDS -
For more information, please contact:
ValiRx plc Tel: +44 (0) 20 3008 4416
Dr Satu Vainikka www.ValiRx.com
Cairn Financial Advisers LLP (Nominated Adviser) Tel:+44 (0) 20 7148 7900
Liam Murray / Avi Robinson
Hybridan LLP (Broker) Tel: +44 (0) 20 7947 4350 / 4361
Claire Louise Noyce / William Lynne
Peckwater PR Tel: +44 (0)7879 458 364
Tarquin Edwards firstname.lastname@example.org
Chart: ValiRx (12mo)
|Security||VALIRX PLC ORD 0.1P|
|Sector||Pharmaceuticals & Biotechnology|
|Market Cap (m)||7.96|
|Shares issued (m)||29.41|
Valirx is a biotechnology company based in London that develops diagnostics and therapeutics for cancer. We were founded in 2006 by entrepreneurial scientists with a long track record in both academic and commercial research. Valirx wants to engineer a scientific breakthrough into human health and wellbeing through early detection of disease and therapeutic intervention. We have three core aims: enhance patient care, achieve faster diagnoses and substantially improve treatment outcomes cost effectively. We achieve these aims by developing effective therapeutic treatments and diagnostic tools for a range of diseases including cancer and neurological diseases. We have two therapeutic products in late stage, pre-clinical development. They both show promise of combating cancer safely and more effectively than currently used chemotherapeutics, hormone therapies and surgical procedures. We have also developed an innovative cancer screening test enables the detection of cancer cells in tissue samples where tumour development is only about to start. This has the potential to have a huge impact on survival rates of individuals with and at risk of developing cancer.
ValiRx plc wants to make a structural change in science, namely to engineer a scientific breakthrough into human health and wellbeing, through early detection of disease and therapeutic intervention. Research shows that there is a high demand for new personalised medicines and services that enhance patient care, achieve faster diagnoses, and substantially improve treatment outcomes cost effectively.
ValiRx is a growing company with a clear business model. ValiRx reduces risk in new product development through a rigorous clinical and commercial due diligence process, selecting drug candidates and technologies with evidence-based potential to address the unmet needs of the market. We aim to maximise human health sciences by adding value at the earlier stages where value increases per investment unit are the greatest.
The ValiRx management team is a mixture of entrepreneurial scientists and business professionals, all with experience in developing medical life science companies.