On October 22, 2020 Phosplatin Therapeutics, a clinical stage pharmaceutical company focused on oncology therapeutics, reported that the first patient has been dosed in the Phase 2 study of PT-112 in patients with metastatic castration-resistant prostate cancer (mCRPC) (Press release, Phosplatin, OCT 22, 2020, View Source [SID1234568876]). The Phase II study builds upon encouraging signals of drug activity observed in Phase 1 studies previously reported, and will enroll up to 60 patients. PT-112 is a small-molecule immunogenic cell death inducer that is the first pyrophosphate conjugate under active development within anti-cancer therapy. The pyrophosphate component of PT-112 engenders osteotropism that is advantageous in dealing with mCRPC that metastasizes to the bone.
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"The initiation of this Phase 2 study represents a significant milestone for patients and our company, as we continue to assess PT-112 as a monotherapy in heavily pre-treated mCRPC patients, who currently have limited therapeutic options," said Joseph F. O’Donnell, MD, Interim Chief Medical Officer of Phosplatin. "Advanced metastatic prostate cancer is known to be immunologically ‘cold’ and to have an extremely high rate of bone metastatic disease. With PT-112’s unique combination of immunogenic cell death induction and osteotropism, we hope to replicate positive results from our Phase 1 studies, including reduction in disease burden and pain."
The purpose of the Phase 2 multi-center, open-label study is to confirm the appropriate dose level and to evaluate preliminary evidence of efficacy of PT-112 in late-line mCRPC patients. Secondary objectives include a range of outcome measures that are derived from the Prostate Cancer Working Group 3 (PCWG3) criteria, along with exploratory endpoints and an array of correlative studies using patient samples.
Further information on this clinical trial (NCT 02266745) can be found at clinicaltrials.gov.
About PT-112
PT-112 is a novel small molecule conjugate of pyrophosphate that possesses a unique pleiotropic mechanism of action that promotes immunogenic cell death (ICD) through the release of specific damage associated molecular patterns (DAMPs) that bind to dendritic cells and lead to downstream immune effector T-cell recruitment in the tumor microenvironment. PT-112 represents the best-in-class small molecule inducer of this immunological form of cancer cell death and is under Phase 2 development. The first in-human study of PT-112 demonstrated an attractive safety profile and evidence of long-lasting responses among heavily pre-treated patients and won "Best Poster" within the Developmental Therapeutics category at the ESMO (Free ESMO Whitepaper) 2018 Annual Congress. The novelty of PT-112’s pyrophosphate moiety also results in osteotropism, or the propensity of the drug to reach the mineralized bone. This property is of interest in cancer types that originate in or metastasize to the bone. The first human clinical results in mCRPC were presented at the 2020 Genitourinary Cancers Symposium.