As per the latest announcements by Noxopharm Limited (ASX: NOX), the clinical-stage drug development company has now received positive interim results from its LuPIN trial VeyondaÂ® (NOX66) dose-finding study focused on investigating 177Lu-PSMA-617 in combination with VeyondaÂ® in men with late-stage metastatic castration-resistant prostate cancer (mCRPC). The news sent the stock price to jump up by 18.182%, settling the dayâs trading session at $0.650 as on 20 May 2019. A total of 978,385 shares changed hands as against an average volume of 109,447 (on a yearly basis), and this reflects a significant jump in terms of trading volume.
In the latest market announcement, clinical-stage drug development company, Noxopharm reported that interim results from LuPIN trial, an investigator-initiated trial, would be delivered by Associate Professor Louise Emmett in an oral presentation at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2019 Annual Meeting, scheduled to be held on 25 June 2019. However, an abstract of this data has already been published on the SNMMI website and will be published in the Journal of Nuclear Medicine in near future.
The trial results demonstrated an overall PSA (prostate-specific antigen) response rate of 69% across the 16 patients from the combination of 177Lu-PSMA-617 (Lutetium-PSMA-617) and VeyondaÂ®, reportedly higher than that observed in studies of 177Lu-PSMA-617 alone.
Background of the Study:
As indicated by the company, the LuPIN Study is a Phase 1b study in 32 men with mCRPC where the disease is end-stage and progressing, despite treatment with cabazitaxel, docetaxel, and either abiraterone or enzalutamide. Under this study, the company evaluates VeyondaÂ® (innovative dosage formulation of the experimental anti-cancer drug compound, idronoxil) for its ability to increase incidence, degree, and durability of a response to radioligand therapy, 177Lu-PSMA-617. The men are receiving up to 6 courses of treatment with VeyondaÂ® and 177Lu-PSMA-617 at six-weekly intervals.
It is worth noting that 177Lu-PSMA-617 outlines a potential radioligand therapy that targets prostate-specific membrane antigen (PMSA) on the surface of prostate cancer cells. It has been assessed on an experimental basis over the past five years, mainly in Germany and Australia, in several thousand men with end-stage prostate cancer with no remaining treatment options, with Associate Professor Louise Emmett and St Vincent Hospital playing a key role.
LuPIN Study Details (Source: Companyâs Website)
The objective of the study is to see if radio-enhancing and immuno-stimulatory properties of VeyondaÂ® could increase both the rate of response (more men able to complete the full course of treatment) and the durability of the response (longer time before disease progression) to 177Lu-PSMA-617 in men with late-stage mCRPC. It, therefore, aims at evaluating safety and efficacy of combination of 177Lu-PSMA-617 and NOX66 in men with mCRPC post-androgen signaling inhibition and 2 lines of taxane chemotherapy (LuPIN trial).
Latest interim results from the LuPIN trial
The latest interim report is based on first 16 subjects, all of whom were reportedly given ≥ 2 doses of 177Lu-PSMA-617 with varied does of VeyondaÂ®. The data reported that the first eight men received 400 mg of VeyondaÂ®, and following a safety data review, the dose for patients 9-16 was escalated to 800 mg of VeyondaÂ®.
The effect of VeyondaÂ® was measured by its effect on the PSA response rate and its tolerability and safety profile. At the interim stage, the company received as high as 75% PSA response rates from 800mg (8 patients) dosages of VeyondaÂ®. The PSA response rates for 400mg (8 patients) was noted as 62.5%, taking the overall PSA response rate to 69% across the 16 patients. This achievement stands favourable when compared with PSA response rates of 177Lu-PSMA-617 alone, (31% - 61%) in 10 published trials. The enhanced response rate has been achieved in a well-tolerated way, with only one severe adverse event (pneumonitis) being reported.
Greg van Wyk, companyâs CEO and CMO, stated that the interim data has indicated positive results on the likely potential of VeyondaÂ® to increase the rate of responses to 177Lu-PSMA-617. The company now awaits results from the next 16 patients in the 800 mg dose expansion cohort to understand impact on these patients over the longer-term.
The trial underscores the companyâs objective to develop VeyondaÂ® as an enhancer of radiotherapy across all its forms, including radiopharmaceuticals. The dual-acting cytotoxic drug candidate, VeyondaÂ®, is being developed to be used in combination with chemotherapy and radiotherapy for the treatment of prostate and other cancers in safe and well-tolerated way.
NOX is currently trading at $0.630,up 1.61% (as on 11:43 AM AEST, 22 May 2019).
This website is a service of Kalkine Media Pty. Ltd. A.C.N. 629 651 672. The website has been prepared for informational purposes only and is not intended to be used as a complete source of information on any particular company. The above article is sponsored but NOT a solicitation or recommendation to buy, sell or hold the stock of the company (or companies) under discussion. We are neither licensed nor qualified to provide investment advice through this platform.