Cleveland BioLabs, Inc
) announced that it has achieved all objectives in a phase I
trial on oncology candidate, CBL0102 (quinacrine).
The trial (n=32) was conducted in patients suffering from
advanced cancers. We note that CBL0102 is being developed by
Incuron LLC, a joint venture between Bioprocess Capital Ventures
and Cleveland BioLabs.
The primary endpoint of the study was to evaluate the maximum
tolerated dose and the dose-limiting toxicities of CBL0102 in
patients with advanced cancers while the secondary endpoints were
to evaluate CBL0102's safety and pharmacokinetics.
The patients received sequentially higher starting doses of
CBL0102. It was observed that CBL0102 successfully achieved both
the primary and secondary objectives.
It was also observed that CBL0102 was generally well
tolerated. Consequently, a recommended dose of 400 mg/day was
established for a phase II study.
We remind investors that CBL0102 enjoys orphan drug status in
the U.S. for the treatment of hepatocellular carcinoma since Oct
Meanwhile, Case Comprehensive Cancer Center, in cooperation
with the National Cancer Institute, recently initiated a phase
I/II study evaluating the safety and efficacy of the combination
) Tarceva and CBL0102 in patients suffering from stage IIIB-IV
non-small cell lung cancer.
We are encouraged by the positive results of the phase I
trial. Cleveland BioLabs is now looking for a partner for the
potential development of CBL0102 as well as support
The pipeline at Cleveland BioLabs looks interesting. The lead
candidates of the company include Entolimod, which is being
developed as radiation countermeasure and a potential cancer
treatment and Curaxin CBL0137 for cancer.
Cleveland BioLabs currently carries a Zacks Rank #2 (Buy).
Other stocks that look equally attractive include
Dynavax Technologies Corporation
). Both carry a Zacks Rank #2.
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