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news.Bio-Path Holdings has initiated development of Liposomal Bcl-2 (L-Bcl-2) as a treatment for follicular lymphoma.
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L-Bcl-2 is a liposomal encapsulated oligonucleotide targeted to the translation initiation site of human Bcl-2 mRNA.
The antisense oligonucleotide in L-Bcl-2 is a nuclease-resistant, hydrophobic analog of phosphodiesters containing its P-ethoxy backbone.
The company has already completed preclinical package of toxicity, tissue distribution, pharmacokinetics and efficacy studies, while it intends to submit an investigational new drug (IND) application (IND) in the first half of 2015.
Bio-Path is focused on developing a liposomal delivery technology for nucleic acid cancer drugs.
In preclinical trials, L-Bcl-2 showed excellent toxicity and efficacy, while the in vivo studies of follicular lymphoma in SCID mice showed a 60% survival rate, with the treated mice remaining alive while continuing to receive on-going treatment with the compound.
The Phase I clinical trial design will use a standard 3+3 dose escalation design, with 50% dose escalation with each round.
The company’s drug delivery technology involves microscopic-sized liposome particles that distribute nucleic acid drugs systemically and safely throughout the human body, via simple intravenous infusion.