VALIRX PLC
("ValiRx" or the "Company")
US PATENT GRANT FOR THERAPEUTIC COMPOUND, VAL301
"DELIVERING VALUE & MARKET OPPORTUNITY FOR
VALIRX'S ENDOMETRIOSIS PROGRAMME"
London, UK., 17 July 2018: ValiRx Plc (AIM: VAL), the clinical stage biotechnology company, is pleased to announce that the United States of America patent and trademark office has granted a US Patent for ValiRx's pre-clinical therapeutic compound, VAL301, for the treatment of the gynaecological disorder, endometriosis or hormone induced abnormal cell growth in women, for which there is substantial global unmet medical need. According to DelveInsight, the endometriosis market is predicted to reach $1.91 billion by 2023.
The patent for VAL301 entitled: "Inhibitors of the interaction between a src family kinase and an androgen receptor of estradiol receptor for the treatment of endometrioses," now provides protection for ValiRx for this indication in the world's largest pharmaceutical market.
Endometriosis occurs when tissue similar to the lining of the uterus, or endometrium, migrates outside of the womb, generally to the fallopian tubes, ovaries and tissue around the uterus. The resulting symptoms are debilitating for an estimated 1 in 10 women in the United States and an estimated 200 million women worldwide and the condition represents one of the biggest health issues for females of reproductive age.
The symptoms include inter alia inflammation, severe cramps, heavy and prolonged menstrual flow, nausea and vomiting, chronic fatigue, long-term pelvic pain and infertility. Currently, there is no known cause of endometriosis, and because the development of the condition is poorly understood, there are no known ways to cure or prevent it. Its management is often hit or miss, and sometimes includes multiple surgeries and hormonal treatment. As such, the condition also has a significant economic impact.
VAL301 has evolved from the Company's peptide (VAL201), which has been shown to reduce abnormal endometrial growth, whilst leaving other hormone-induced activities working normally. ValiRx's initial in-vitro results show a reduction in endometrial lesion size directly related to dosage and two generations of offspring produced by treated animals. This strongly suggests that the peptide does not affect fertility the same way other treatments do. Also, a pre-clinical study in an animal model has indicated that VAL301 is unlikely to affect bone density, another unwanted side effect often reported with hormone therapies. These findings suggest an important step in the development of precision medicine for a complex disease that has to date been very difficult to classify and predict.
ValiRx is currently completing pre-clinical work and preparing protocols and submission paperwork for clinical trials in endometriosis.
Dr Satu Vainikka, CEO of ValiRx, commented: "This US patent grant is excellent news for VAL301 and for our opportunity of trying to address this little known, but hugely widespread and debilitating chronic illness, that affects a very substantial number of women around the world. New targeted treatments with minimal side effects are needed, particularly when considering the target patient group - young women of child-bearing age.
"The only treatments available today are pain management via pain killers, unpleasant and invasive surgery or hormonal treatments, which are known to have side-effects. VAL301 therefore offers a potentially effective treatment that does not affect fertility the same way other treatments do and according to pre-clinical studies, it is unlikely to affect bone density either, another unwanted side effect often reported with hormone therapies. The pre-clinical and clinical development of VAL301 is likely to greatly benefit from the good progress seen in the Phase I/II clinical trial of our prostate cancer therapeutic, VAL201, particularly as far as safety and tolerability are concerned and as such, I believe we have significant further value to explore from this asset."
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.
*** ENDS ***
For more information, please contact:
ValiRx plc |
Tel: +44 (0) 20 3008 4416 www.valirx.com |
Dr Satu Vainikka, Chief Executive |
Tel: +44 (0) 20 3008 4416 |
Tarquin Edwards, Head of Communications. |
Tel: +44 (0) 7879 458 364 [email protected] |
Cairn Financial Advisers LLP (Nominated Adviser) Liam Murray / Jo Turner |
Tel: +44 (0) 20 7213 0880 |
Novum Securities Limited Colin Rowbury |
Tel: +44 (0) 20 7399 9400 |
Notes for Editors
About ValiRx
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.
