Clinical-Stage drug development company, Noxopharm Limited (ASX: NOX) has announced a notable expansion of its investigator-initiated trial, LuPIN, at the back of encouraging interim results observed to date in LuPIN trial VeyondaÃÂ® (NOX66) dose-finding study.
In the announcement dated 23 May 2019, Noxopharm unveiled the decision to recruit an additional 24 patients in its ongoing LuPIN trial, in addition to the initial 32 patients enrolled to date. The additional dose cohort will comprise 24 patients who will reportedly be treated with VeyondaÃÂ® 1200 mg daily for 10 days in combination with 177Lu-PSMA-617.
As indicated by NOX, the LuPIN study led by Associate Professor Louise Emmett at St VincentÃ¢ÂÂs Hospital in Sydney, focuses on evaluating VeyondaÃÂ® for its potential ability to increase the rate of response and the durability of responses to Lutetium-177 (177Lu) labelled PSMA-617 (referred to as 177Lu-PSMA-617) in men with late-stage metastatic castration-resistant prostate cancer (mCRPC).
177Lu-PSMA-617 is an experimental radiopharmaceutical therapy that has the ability to reach prostate cancer cells throughout the body and to deliver radiotherapy in a highly targeted way.
Expansion of NoxopharmÃ¢ÂÂs LuPIN trial by additional 24 patients
NoxopharmÃ¢ÂÂs decision to proceed with the trial expansion is placed on the companyÃ¢ÂÂs objective to evaluate whether the dose-response effect observed to date will lead to even greater response rates. It underlines the companyÃ¢ÂÂs core objective to bring VeyondaÃÂ® to market as a versatile adjunct to radiotherapy in prostate cancer.
Dr. Greg van Wyk, CEO and CMO of Noxopharm, stated that support of St VincentÃ¢ÂÂs Hospital, Sydney, a leader in the field of theranostics, to NoxopharmÃ¢ÂÂs trial expansion plan represents a big step forward in its efforts to establish VeyondaÃÂ® as a standard co-treatment with radiotherapy in prostate cancer.
He added that VeyondaÃÂ® 1200 mg has proven to be well tolerated in combination with external beam radiotherapy, similar to the combination of VeyondaÃÂ® 800 mg and 177Lu-PSMA-617 in the LuPIN trial to-date.
Under the trial, first 8 eight men received 400 mg of VeyondaÃÂ® daily (on days 1-10 of each cycle). The dose for next 9-16 patients was escalated to 800 mg of VeyondaÃÂ® following a safety data review. Post completion of the next safety data review of these 9-16 patients, a set of another 16 patients was recruited for administering the same dose of 800 mg of VeyondaÃÂ®.
The LuPIN-1 trial will now enrol a further 24 patients (with progressing mCRPC despite having received cabazitaxel, docetaxel, and either abiraterone or enzalutamide), who will be given VeyondaÃÂ® 1200 mg daily for 10 days in combination 177Lu-PSMA-617. The trial aims to administer the patients up to 6 cycles of 177Lu-PSMA-617 at six-weekly intervals in combination with VeyondaÃÂ®.
Associate Professor Louise Emmett, Director of Theranostics and Nuclear Medicine at St VincentÃ¢ÂÂs Hospital, Sydney, stated: Ã¢ÂÂThe nominal difference in response rates between VeyondaÃÂ® 400 mg and VeyondaÃÂ® 800 mg encouraged us to explore the dose effect more robustly by adding a 1200 mg cohort.Ã¢ÂÂ
The recently released announcement of interim trial results presented an overall prostate-specific antigen (PSA) response rate of 69% across the first 16 patients with mCRPC, with the generally tolerable and safe treatment to date using VeyondaÃÂ® in combination with 177Lu-PSMA-617.
The encouraging results materialising from the LuPIN trial are expected to lay the foundations for a pivotal Phase II/III registration trial, which has a potential to see VeyondaÃÂ® becoming a standard of care adjunct to 177Lu-PSMA-617.
NOX has indicated that the interim results from LuPIN trial VeyondaÃÂ® (NOX66) dose-finding study will be presented in an oral presentation by Associate Professor Emmett at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2019 Annual Meeting, due to be held on 25 June 2019.
NOX is trading at $0.610 as on 27 May 2019 (12:38 PM AEST). The stockÃ¢ÂÂs year-to-date return stands strong at +48.78%, with a surge of 22% recorded in the past six months.
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