The Company’s leading anti-cancer therapeutic VAL201 is currently in clinical trials for the treatment of prostate cancer and potentially other indications of hormone induced unregulated growth including endometriosis. The Phase I/II trial has entered the concluding stages of it’s study at University College London Hospital (“UCLH”) and this follows the company receiving approval from the Medicines and Healthcare products Regulartory Agency (“MHRA”) to escalate VAL201 dosing. The curent cohort hs already received the escalated dose and UCLH continues to recruit suitable patients to complete the trial.
Progressing through the dose escalation and expansion stages, the study is then designed to investigate further safety and tolerability aspects as well as efficacy. Particular emphasis will be placed on evaluating the pharmacokinetics, pharmacodynamics and early assessment of anti-tumour activity in response to VAL201, using a variety of measurements including biomarkers, with biomarkers being key indicators in personalised medicine.
VAL201 selectively prevents tumour growth by specifically inhibiting the proliferation of tumour cells. As a result, tumour growth is suppressed and metastasis is significantly reduced. The approach is a targeted therapeutic with pre-clinical results that indicate that due to the specific nature of this treatment, this therapy is likely to be less toxic than many other therapeutic options. The VAL201 target is also associated with other cancers and there is significant potential for VAL201 to be used as a treatment for other hormone-induced cancers, such as breast and ovarian cancer, alongside endometriosis.
Endometriosis is a gynaecological medical condition in which cells from the lining of the uterus (endometrium) appear and flourish outside the uterine cavity 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 and symptoms often worsen with the menstrual cycle. The treatments chosen will depend on symptoms, age, and lifestyle plans. VAL201 has been shown though 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 dose 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.
Lung Cancer and others
VAL401 is the reformulation of a generic drug that has over 20 years of clinical use for treatment of a chronic non-oncology disease in an oral capsule. The re-formulation allows the drug to access previously unexploited anti-cancer activity. VAL401 has completed a clinical Phase II trial for the treatment of late-stage non- small cell lung cancer with data from the completed trial indicating a palliative effect and an improvement of quality of life in the patients treated.
Progress of VAL401 through its clinical trials will follow an accelerated route to Market Authorisation through the use of prior clinical data gathered on the original generic drug. Pre-clinical efficacy data has been collected in non-small cell lung, pancreatic and prostate cancers. Pre-clinical toxicology has revealed no side effects beyond those expected from the parent drug, with both pre-clinical and clinical pharmacokinetc data allowing bridging from VAL401 to the historical full clinical data package on the parent. ValiSeek is currently in discussions with potential partners for starting the next clinical trial.
During 20 years of prior clinical use, the active drug has been safely administered long term (chronic use of over 2 year’s duration) with good compliance.
Other possible indications include prostate and pancreatic cancer.
GeneICE “rebellious gene” technology continues to show good progress in the pre-clinical phase – the programme currently benefits from a second Eurostars grant for up to €1.6 million.
Rebellious genes are genes that are overexpressed or are erroneously expressed when they should not be, e.g. in cancers, inflammatory conditions, Alzheimer’s and autoimmune diseases. ValiRx’s proprietary GeneICE forward, ValiRx will look to leverage upon TRAC’s market presence and grow the sales of this diagnostic business. The Company believes that together with clinical validation, revenues from TRAC will grow, which will support both the biomarker and therapeutic development businesses. ValiFinn, which is itself already generating revenues, is well placed to further develop as a service/licensing business.
VAL101 is a novel therapeutic based on the Company’s proprietary GeneICE (Gene Inactivation by chromatin engineering) platform. It acts to target and switch “OFF” the gene that expresses Bcl-2, a protein that is implicated in about half of all carcinomas. Pre-clinical studies have established VAL101’s efficacy in prostate, ovarian and pancreatic cancers and it may also have anti-tumour activity against orphan oncologic indications. ValiRx’s GeneICE technology enables the selective silencing or the shutting down of particular rebellious genes, thereby halting and reversing tumour growth.