Highlights:
RMWC provided Invion with a clinical study summary report collated by Scendea Limited (Scendea) using information received and relied upon from RMWC based on the results of the investigator-led and open label trial that was fully funded by RMWC. Scendea is a leading pharmaceutical development and regulatory consulting group.
The Phase II prostate cancer trial used six treatment cycles of INV043 as a monotherapy. It was found to be safe and well tolerated by patients with no serious adverse events experienced and all side effects reported were mild.
In terms of efficacy signals, 40% of patients showed a positive response to the treatment with 10% demonstrating complete regression as measured by the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 framework – a standard way to measure the response of a tumour to treatment.
Further, 44% of patients had negative Prostate Specific Membrane Antigen – Positron Emission Tomography (PSMA-PET) results three months post treatment (all patients were positive before the treatment).
The report concluded that “the favourable safety profile and the preliminary efficacy results are promising and warrant further investigation of INV043”. Further details of the study are included in the sections below.
However, this approach may cause anxiety among patients who will have to live with the cancer without knowing if it will one day become more severe or even life-threatening.
Commenting on the results, Invion’s Executive Chair and Chief Executive Officer (CEO) Thian Chew said:
“It’s very exciting to see these results for our lead cancer candidate, INV043. The results showed that INV043 can be safely administered and activated with light to treat prostate cancer. It also highlighted its potential to be safely administered systemically to patients, including via sublingual and even IV routes.
“Together with the positive efficacy signals from this trial, this points to the prospect of INV043 to become an effective treatment for prostate cancer without the devastating side effects that can be associated with conventional treatments.”
Prostate cancer is the second most common cancer in men3. The global prostate cancer market is expected to grow to around US$27.5 billion by 2032, representing a compound annual growth rate (CAGR) of 8.7% over the forecast period from 2023 to 20324.
Invion’s patented lead Photosensitiser, INV043, was developed to preferentially target and accumulate in tumour cells, and not healthy cells. The trial design focused on the safety and efficacy of sublingually administrated INV043 as a monotherapy and the use of a laser probe to apply red light to the prostate/prostatic fossa using transurethral and/or transrectal intraluminal techniques.
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