US-based biotechnology firm Bio-Path Holdings has started development of Liposomal Bcl-2 (L-Bcl-2) as a treatment for follicular lymphoma.
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 used by the company 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 studies, 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.
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According to the company, the Phase I clinical trial design will use a standard 3+3 dose escalation design, with 50% dose escalation with each round.
The company expects that the favourable toxicity profile of its lead drug candidate Liposomal Grb-2, currently in clinical trials, will allow it to start this Phase I trial at a higher dose.
Based on the data, the company is planning a Phase I clinical trial for Liposomal Bcl-2 that will require five groups and only 15 patients.
Bio-Path president and chief executive officer Peter Nielsen said: "Initiating development of our second compound is an important step for the company as it broadens Bio-Path’s pipeline and opportunities.
"Bcl-2 overexpression is reported to be involved in a large number of cancer indications. Due to the low toxicity demonstrated in Bio-Path’s product candidates, Liposomal Bcl-2 has the unique potential to be used in higher doses that could potentially enable it to knock down resistance of tumours to chemotherapy.
"There is tremendous potential for Bio-Path’s Liposomal Bcl-2 to make significant contributions to the treatment of a large number of cancers.
"Furthermore, with the knowledge gained from our first product candidate; importantly, the toxicity profile of the compound, we estimate that this clinical trial will be conducted more quickly and at a lower cost.
"Our proprietary platform provides us with a strategic advantage for building a pipeline of opportunities that share similar characteristics and manufacturing techniques, allowing for an efficient and focused development programme."
The company’s drug delivery technology involves microscopic-sized liposome particles that distribute nucleic acid drugs systemically and safely throughout the human body, through simple intravenous infusion.