{"id":904,"date":"2018-08-28T00:00:00","date_gmt":"2018-08-27T23:00:00","guid":{"rendered":"https:\/\/www.innovationnewsnetwork.com\/lung-cancer-therapeutics-valiseek\/904\/"},"modified":"2018-08-28T00:00:00","modified_gmt":"2018-08-27T23:00:00","slug":"lung-cancer-therapeutics-valiseek","status":"publish","type":"post","link":"https:\/\/www.innovationnewsnetwork.com\/lung-cancer-therapeutics-valiseek\/904\/","title":{"rendered":"A new venture in lung cancer therapeutics for ValiSeek"},"content":{"rendered":"

ValiSeek Limited is a single asset company, overseeing the development of the therapeutic VAL401 through the final stages of clinical trials for the treatment of\u00a0lung cancer. Despite having a well-trodden path to follow, a closer look shows some of the twists and turns taken along the way. Founder and entrepreneur, Dr Suzanne Dilly, explains.<\/h2>\n

Our pilot Phase 2 clinical trial was completed last year, so the last 12 months have been really exciting, if not sometimes nail biting. By year-end, we were able to share data showing that our eight end-stage lung cancer patients, once treated, displayed a statistically significant improvement in overall survival time, compared with a group of untreated case-matched lung cancer patients. Data added in January showed that these lung cancer patients not only lived longer, but reported improvements in quality of life, particularly in measures of pain, nausea and overall feeling of wellbeing.<\/p>\n

These headlines were fantastic, but a little more explanation is needed to expand on the remaining challenges \u2013 with the need to identify and secure a rather particular kind of investor that can show not only the flexibility and risk tolerance of any who may be looking at the life science sector, but also the intelligence and vision to really understand the opportunity for lung cancer treatment.<\/p>\n

The reformulation of drug Risperidone<\/h3>\n

VAL401 is a reformulation of an established drug, Risperidone, into a liquid-filled capsule. Risperidone is a popular anti-psychotic, prescribed chronically for psychotic conditions worldwide, and is listed on the World Health Organization\u2019s list of essential medicines. Several anti-psychotic drugs have been studied for anti-cancer benefits, but with a lack of scientific consensus, it is generally agreed that they do not offer such benefits.<\/p>\n

Our laboratory experiments revealed that Risperidone can inhibit an enzyme (HSD10) that is key to metabolism in cancerous cells. However, Risperidone alone cannot enter these cells, as the anti-psychotic properties are all activated by interactions at the cell surface. Our VAL401 lipid formulation, looking much like a cod liver oil capsule, allows Risperidone to enter and, specifically in cancerous cells, stop the enzyme, thus breaking the cell cycle. Our experiments with lung cancer, pancreatic, and prostate adenocarcinoma cancers demonstrated that VAL401 reduced the rate of tumour growth.<\/p>\n

Patenting success<\/h3>\n

From a scientific perspective, the formulation requirement is elegant, providing a rationale for why the past studies of anti-psychotics in cancer have been so mixed. From a commercial perspective, the formulation requirement enabled patent examiners to identify a clear line of novelty and inventiveness, allowing patents to be granted for both the composition of the VAL401 formulation and use of such in the treatment of adenocarcinoma. Patents have been granted in various territories, including the USA, Australia and New Zealand, with major territories across all continents currently under examination. Importantly, the US patents include the method of treatment of adenocarcinoma, recognising that the mechanism of activity suggests all adenocarcinomas should be susceptible.<\/p>\n

With the formulation recognised as essential for anti-cancer activity, an oncologist cannot take the cheap, generic Risperidone from the shelf for their patient. Yet, with the use of a well-known active, pharmaceutical ingredient, we hope VAL401 can provide an affordable treatment in oncologists\u2019 toolkit.<\/p>\n

Recycling existing drugs for the future of oncological treatments<\/h3>\n

Recycling an old drug allowed us to plan our clinical trial with a great deal of confidence, knowing that the drug would not do anything particularly unexpected. This drastically reduced the amount of lab-based toxicology required before moving into dosing human subjects, cutting costs, times, and significantly reducing animal experiments.<\/p>\n

We initially proposed entry directly into a single, multi-national, 200-patient trial, in order to achieve sufficient data to request market authorisation. However, on consultation with the regulatory authorities, we decided to run the pilot study first with a small handful of patients to check for surprise results. Although the active drug has been widely used for decades, our formulation stimulates previously inaccessible biological activity, so we needed to be sure it wouldn\u2019t also encourage previously unseen side effects.<\/p>\n

Recording the biological effects of therapeutics<\/h3>\n

In a clinical trial, all \u201cadverse events\u201d are recorded, regardless of the association to the drug being trialled. The side effects that we saw could be categorised as:<\/p>\n