Invion has produced a new topical and intravenous product suitable for use in skin cancer and in solid tumours, such as those present in ovarian, prostate and lung cancer.
Given the significant commercial and clinical potential of its assets, Invion will look to progress multiple programs and commence pre-clinical and clinical trials in 2019. They include topical indications for Basal Cell Carcinoma and Actinic Keratosis (skin cancer and precancerous cells) and intravenous indications for mesothelomia. Invion will also further explore the application of the PhotosoftTM technology in ovarian, lung and prostate cancer.
For more on each development, see the information below.
As such, Invion recently appointed lung cancer consultant Assoc. Prof Louis Irving to the Company’s Scientific Advisory Board. Invion is planning to expand its operations to include intravenous applications of its PDT treatment for lung cancer.
The company will look to expand this development throughout 2019.
The treatment aims to address a known gap in current treatment options for ovarian cancers, which have a five-year mortality rate greater than 70 per cent. Also, ovarian cancer patients almost universally develop recurrent, chemo-resistant disease.
Researchers compared the efficacy of four photosensitisers used in PhotoDynamic Therapy, including Photosoft Oral and an improved formulation of PhotosoftTM technology called IVX-P02, in in vitro tests against ovarian cancer cells.
Of the in vitro tests’ findings, the most significant was the effectiveness of the IVX-P02 – found to have 15-fold greater in vitro cytotoxicity against ovarian cancer cells, compared to Photosoft Oral.
Trials on mice with advanced ovarian cancer and which have had IVX-P02 administered intraperitoneally have shown that The IVX-P02 compound clearly identifies cancerous tumour tissue, accumulates in the tumour tissue and is not taken up by normal tissue.
Invion's research with The Hudson Institute lays the foundation for ongoing 2019 preclinical trials of IVX-P02 as a potentially viable commercial treatment for ovarian cancer.
On the basis of pre-clinical studies conducted to date, it is expected that the reaction of visible light and oxygen with the IVX-P02 gel will kill the cancer cells on the patient’s skin, leaving surrounding cells unharmed.
Invion expects its IVX-P02 gel will be more powerful than currently available topical therapies used to treat skin cancer and could offer skin cancer patients a new treatment option.
The company aims to have the fast-drying IVX-P02 gel ready for testing in human clinical studies in the first half of 2019. Invion has engaged industry experts Formulytica and vivoPharm to develop and test the IVX-P02 gel, and appointed cancer specialist Dr Lynda Spelman to the Company’s Scientific Advisory Board in January 2019 to ensure that drug development for application to skin cancer is optimised.
Invion's skin cancer treatment – referred to as IVX-SKIN – will be in pre-clinical studies in the first and second quarters of 2019 and is expected to enter into Phase Ib human trials for the treatment of BCC in the third and fourth quarters.
Phase III human trials for the treatment of BCC and AK and are expected to commence in late 2019 and early 2020 respectively, to be followed by the start of the registration process in mid-2020.
Invion expects to test an intravenous formulation – IVX-MES – in healthy volunteers in a Phase I trial commencing in the third quarter of 2019 and runnig until the second quarter of 2020. Invion will consider follow-on trials in a range of cancers.
Invion expects to progress straight to a Phase III mesothelioma trial commencing in the second quarter of 2020 and running until the second quarter of 2022. The Phase III trial aims to determine the impact of an intravenous formulation of IVX-MES plus surgery in patients with malignant pleural mesothelioma.
Invion is targeting an application for registration in the first quarter of 2021 and approval in the second quarter of 2022.