ValiRx Plc (AIM: VAL), the clinical stage biotechnology company, is pleased to announce that the United States of America patent and trademark office has given notice of allowance for the US Patent Application No. 14/575065 (“Anti-Androgen Peptides and Uses Thereof in Cancer Therapy”) covering ValiRx’s lead therapeutic compound, VAL201, which is in clinical trials.
The patent application covers the molecule and use of compounds in pharmaceutically acceptable products. The patent coverage also includes a wide variety of derivatives, modifications and analogues of the compounds and their mode of action. Furthermore, the protection sought includes therapeutic formulations with associated delivery systems.
Allowance of this US patent for VAL201 will represent one of the cornerstones of the Company’s commercial strategy, since ValiRx has already secured patent protection in several other territories, including Europe. This positioning, in having patent protection in major markets, is in line with the pharmaceutical industry’s increasing search for novel proprietary therapies in the oncology arena.
The table below provides details of patents in the VAL201 portfolio that have been either fully granted or allowed.
There are patent applications currently pending in many other territories and covering various aspects of the programme.
As announced on 18 December 2017, the compound is currently in a Phase I/II study primarily assessing safety and tolerability of VAL201 and its effect in the treatment of prostate cancer and other solid tumours. No dose limiting toxicity has been observed, nor have there been any therapeutically-related side effects (Serious Adverse Events).
So far VAL201 has met and exceeds the predicted safety and tolerability criteria set for the trial. Subjects have shown preliminary therapeutic efficacy and significant changes in their PSA levels related to treatment with VAL201. These are in line with pre-clinical studies, which have shown efficacy in prostate, breast and ovarian cancer models as well as addressing endometriosis or hormone induced abnormal cell growth in women.
Dr Satu Vainikka, CEO of ValiRx, commented:
“It is timely and very exciting to receive this notification of allowance for the VAL201 patent. This being only weeks after we received approval from the UK Medicines and Healthcare Products Regulatory Agency and Research Ethics Committee for the Company to expand its VAL201 trial to more speedily reach VAL201’s full therapeutic potential and potential anti-cancer impact. This US allowance means we can proceed to strengthen the VAL201 patent portfolio and, once granted, will provide ValiRx with patent protection in all its largest commercial markets globally. ValiRx looks forward optimistically to its future prospects.”
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