Noxopharm Limited (ASX: NOX) reported the continued progress of Veyonda® clinical program in its quarterly report for the period ended 31 March 2019. The news sent the stock price to jump up by 8.696% in a mid-day trade on 26 April 2019.
During the quarter, the company’s focus remained on running a clinical program designed to confirm its benefit in enhancing the anti-cancer activities of chemotherapy and radiotherapy and as an immuno-oncology drug.
The Company believes that Veyonda® has the potential to become a transformative drug in the treatment of most forms of cancer. Therefore, Noxopharm undertook a strategic review of its clinical study and commercial plans during the March quarter. The review was directed at raising the company’s profile and Veyonda®, in both global capital markets and the global pharmaceutical industry.
The three different clinical programs are currently deployed under Veyonda® that includes cytotoxic chemotherapy (CEP Program), external beam radiotherapy (DARRT Program), and intravenous radiopharmaceuticals (LuPIN Program).
Under CEP-1 Phase 1b clinical study, the company noted that of the 9 patients in this study given the higher dosage (800 mg) of Veyonda®, 5/9 showed stable disease or better over the 8- month term of the study, an outcome regarded by medical advisors as highly significant clinically given the advanced nature of disease in these patients.
Noxopharm further intends to take the CEP approach to the next level by testing a combination of Veyonda® and doxorubicin in sarcomas. This study is to be run in the U.S., with a start date of Q4 2019. As per the company’s information, the necessary Medical Advisory Board of sarcoma specialists has been assembled, and Noxopharm is in discussion with the FDA.
The DARRT treatment regimen in prostate cancer is focused on providing a material symptom-free survival benefit to men with progressive Stage 4 cancer who normally would have a limited life-span characterised by growing pain and disability. In DARRT-1, the Company is testing a short and non-intrusive course of treatment (10-days Veyonda® + 5-days low-dose radiotherapy to a single lesion) for its ability to stop disease progression, particularly progression of the boney lesions that form the bulk of the disease in end-stage prostate cancer. The company is reportedly looking for evidence of significant falls in PSA levels (> 50% decline) and pain scores (> 30%) at 3 and 6 months as surrogate markers of likely extension of progression-free survival.
The company intends to release the 6-month data from the first 12 patients enrolled in the DARRT-1 Phase 1b study in early-May 2019. This program remains the Company’s signature program and an anticipated eventual approved clinical indication. The follow-up study is proposed for 2020.
Further, the LuPIN study is a 32-man Phase 1b study testing whether Veyonda® can increase the response rate to the radiopharmaceutical, 177lutetium-PSMA-617 (Novartis), in subjects with the same end-stage prostate cancer as being enrolled in the DARRT-1 study. It has been reported that this study is fully enrolled, with interim data from the first 16 patients to be presented to the Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging in Anaheim, CA, in late-June 2019.
Noxopharm ended the March quarter with a Group consolidated cash reserve of AUD$6.2 million. This cash position is expected to provide the Company with sufficient funds to continue with its current planned research, clinical and business activities over the short-term.
NOX is trading at $0.500, up 8.696% as at 26 April 2019 (12:59 PM AEST).