London, UK., 14 June 2018: ValiRx Plc (AIM: VAL), the clinical stage biotechnology company, is pleased to provide an update on the VAL401 commercial development.
The VAL401 clinical trial and data collection is now complete and the regulatory process is moving towards completion with the Clinical Study Report on schedule for submission within the regulatory timeframe of two years from trial approval (July 2018). These current and future development updates now focus on the commercial aspects of the completed science development.
Since the results were released from the VAL401 trial on 16 January 2018, the development has focussed on commercial areas. An advisory board of UK Key Opinion Leaders was consulted, addressing the significance of the results obtained and the positioning of VAL401 in the UK and global market. Advanced conversations have continued with a number of prospective partners with the aim of achieving a partnership, to progress the project appropriately towards eventual patient use. Further validation of the project is demonstrated by the approval of a second patent in New Zealand – further details re set out below.
Advisory board of UK Key Opinion Leaders (“Advisory Board”)
An Advisory board consisting of members of the patient advocate, hospital and consultant community, all with specialisms in oncology and particularly in end-of-life care in cancer patients was convened to discuss the results and impact of VAL401. The meeting was organised and executed by the independent communications company, Hayward Medical, who provided a report detailing the ideas and enthusiasm the participants showed for the development of VAL401 to date. In particular the need for a treatment that can be used to alleviate symptoms even in end-stage patients was highlighted and that the co-prescription of a drug to provide supportive benefits in addition to anti-cancer benefits would be valuable from the beginning of the patient journey, alongside currently used approaches.
The participants’ individual comments included that they would be confident taking VAL401 immediately on cancer diagnosis, alongside standard of care treatment; that every month of additional life secured is priceless, particularly with maintained quality, and in fact that, terminal patients often prefer to retain their Quality of Life than to risk further disruptive treatments.
2018 BIO International Convention
Dr Dilly attended the BIO International Convention in Boston during the week of 4 June 2018. Recognised as the largest partnering and exhibition event in the industry, BIO is an opportunity to access global biotech and pharma companies. Presenting the VAL401 project, Dr Dilly held meetings to progress commercial conversations further with current and future partners, as well as presenting the project to new audiences.
Notification of Acceptance re Second New Zealand patent
ValiSeek has received notification that a further method-of-treatment patent has been allowed by the New Zealand Patent Office covering the use of VAL401 in the treatment of pancreatic adenocarcinoma.
Dr Suzy Dilly, CEO of ValiSeek, commented: “The external validation from both the Advisory Board and wider industry, has provided increased confidence that VAL401, the product, has a valued and needed place in the market. These developments are a valuable addition to our licensing package, clarifying the final stages of clinical testing towards commercial use.”
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.
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ValiSeek Limited (“ValiSeek”) is a joint venture (“JV”) company between ValiRx Plc and Tangent Reprofiling Limited, part of the SEEK Group. ValiSeek was formed to progress the drug VAL401 through its remaining preclinical development and towards Phase II trials for the treatment of lung cancer and other oncology indications.
ValiRx is a biotechnology oncology focused company specialising in developing novel treatments for cancer and associated biomarkers. It aims to make a significant contribution in “precision” medicine and science, namely to engineer a breakthrough into human health and well-being, through the early detection of cancer and its therapeutic intervention.
The Company’s business model focuses on out-licensing therapeutic candidates early in the development process. By aiming for early-stage value creation, the company reduces risk considerably while increasing the potential for realising value. The group is already in licensing discussions with major players in the oncology field.
ValiRx’s two classes of drugs in development, which each have the potential for meeting hitherto unmet medical needs by existing methods, have worldwide patent filings and agreed commercial rights. They originate or derive from World class institutions, such as Cancer Research UK and Imperial College.
Until recently, cancer treatments relied on non-specific agents, such as chemotherapy. With the development of target-based agents, primed to attack cancer cells only, less toxic and more effective treatments are now possible. New drugs in this group-such as those in ValiRx’s pipeline-promise to greatly improve outcomes for cancer patients.
The Company listed on the AIM Market of the London Stock Exchange in October 2006 and trades under the ticker symbol: VAL.
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