On July 31, 2023 Starpharma (ASX: SPL, OTCQX: SPHRY) reported that AstraZeneca has made the decision to discontinue the development of AZD0466, after an internal review, prompted by a small number of asymptomatic adverse events (AEs) that were unrelated to Starpharma’s dendrimer drug delivery technology (Press release, Starpharma, JUL 31, 2023, View Source;mc_eid=bf52dd3418 [SID1234633511]).
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These AEs have been observed in the two clinical trials evaluating AZD0466 in haematological indications (NCT04865419 and NCT05205161). AstraZeneca’s decision follows the implementation of a voluntary partial clinical hold on study NCT04865419 by AstraZeneca, announced by Starpharma on 27 June 2023. The AEs leading to this decision were asymptomatic and detected through routine laboratory testing. The AEs do not adversely impact the therapeutic and commercial potential of DEP.
Starpharma CEO, Dr Jackie Fairley, said: "Whilst this decision is clearly not what Starpharma would have hoped for, we note that it relates to haematological malignancies and at the highest
three dose groups of AZD0466 and was not due to our dendrimer technology.
"DEP has demonstrated multiple benefits in Starpharma’s clinical studies in patients with solid tissue tumours, including significant preferential accumulation in these tumours compared to blood levels."
This development with AZD0466 does not impact Starpharma’s DEP platform, the Company’s internal clinical and preclinical DEP programs, or DEP partnerships. Starpharma’s multi-product DEP License agreement with AstraZeneca remains in effect.