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DRUG:

Ceraxa (nanoliposomal ceramide)

i
Other names: KN-001, KN 001, KN-01, CNL
Company:
PendreaBio
Drug class:
Apoptosis inducer, PP2A activator
2ms
KNAN2001: Study of C6 Ceramide NanoLiposome (CNL) in Patients With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
P1, N=12, Enrolling by invitation, Keystone Nano, Inc | Not yet recruiting --> Enrolling by invitation | Trial completion date: Oct 2026 --> Oct 2027 | Trial primary completion date: Jul 2026 --> Feb 2027
Enrollment open • Trial completion date • Trial primary completion date
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Ceraxa (nanoliposomal ceramide)
7ms
KNAN2001: Study of C6 Ceramide NanoLiposome (CNL) in Patients With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
P1, N=11, Not yet recruiting, Keystone Nano, Inc | N=18 --> 11 | Trial completion date: Dec 2024 --> Oct 2026 | Trial primary completion date: Sep 2024 --> Jul 2026
Enrollment change • Trial completion date • Trial primary completion date
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Ceraxa (nanoliposomal ceramide)
over1year
Ceramide NanoLiposome in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=14, Completed, Keystone Nano, Inc | Unknown status --> Completed | N=24 --> 14 | Trial completion date: Aug 2019 --> Nov 2023 | Trial primary completion date: Aug 2019 --> Aug 2023
Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Metastases
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Ceraxa (nanoliposomal ceramide)
2years
A phase I study of the ceramide nanoliposome in patients with advanced solid tumors. (PubMed, Cancer Chemother Pharmacol)
CNL exhibited an encouraging safety profile and pharmacokinetic parameters, with some signals of efficacy including prolonged stable disease in 1 patient with refractory pancreatic cancer. Pre-clinical data indicate potential synergy between CNL and multiple systemic therapies including chemotherapy, targeted therapy, and immunotherapy. Future studies are planned investigating CNL in combination strategies.
P1 data • Journal • Metastases
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Ceraxa (nanoliposomal ceramide)