Tyrogenex X-82 Poster Presentation at the 2015 American Society for Clinical Oncology (ASCO) Annual Meeting
May 30 2015 - 12:30PM
Business Wire
Tyrogenex, a leader in the development of novel kinase
inhibitors to target angiogenesis, today announced that the
University of Wisconsin presented a new trial concept of
investigational agent X-82, as a “Trials in Progress” poster at the
51st Annual Meeting of the American Society of Clinical
Oncology (ASCO) in Chicago. The study titled, “Pharmacodynamic
study using FLT PET/CT in advanced solid malignancies treated with
a sequential combination of X-82 and docetaxel,” focuses on the
optimization of a VEGFR/PDGFR TKI in combination with
docetaxel.
The study is designed to take advantage of the pharmacokinetic
profile of X-82 by combining it with docetaxel during the VEGF
withdrawal flare to maximize the therapeutic index of chemotherapy.
The University of Wisconsin is conducting the Phase I/II study with
X-82 and docetaxel to determine the safety and efficacy using an
optimized dosing scheme. Once the pharmacodynamics portion of the
study has been completed, enrollment will be expanded with up to an
additional 60 patients.
“We are excited to be involved in the first clinical trial to
evaluate X-82 in combination with docetaxel,” said Justine Bruce,
M.D., Associate Professor, Hematology/Oncology, University of
Wisconsin. “Prior combination trials using VEGFR TKI and
chemotherapy utilized a concurrent and non-sequential approach. The
negative results from these prior combination trials could be
attributed to an antagonist effect from the suboptimal scheduling
of chemotherapy and VEGFR TKI agents.”
Dr. Bruce presented the poster during ASCO’s Developmental
Therapeutics – Clinical Pharmacology and Experimental Therapeutics
poster session.
“Data indicate that X-82 may stop the growth of tumor cells by
blocking some of the enzymes needed for cell growth. We know that
certain chemotherapies, such as docetaxel, kill tumor cells by
stopping them from dividing or by stopping them from spreading. We
believe the addition of X-82 to docetaxel will further decrease
tumor cell growth,” said Michael D. Webb, Tyrogenex President and
CEO. “Additionally, we expect to demonstrate that administering
X-82 and docetaxel one at a time instead of concurrently in
patients with solid tumors may demonstrate lower toxicity and
higher tolerability and efficacy.”
About Tyrogenex
Tyrogenex is developing X-82 as a targeted therapeutic for
ophthalmological diseases and solid tumors. Preliminary data from a
Phase 1 single agent study show that X-82 is well tolerated and did
not exhibit any dose-limiting toxicity during the study.
In oncology, VEGFR tyrosine kinase inhibitors, such as X-82,
typically have demonstrated benefit in a variety of cancers though
dosage, and use of this class in combination with other therapies,
has been limited by side effects. Phase 1 data show that X-82 could
have a significantly lower toxicity profile, which may make it an
ideal candidate for combination therapy.
For ophthalmology, the company has initiated a Phase 2 study
known as “APEX,” for wet AMD in Previously treated
Eylea patients with X-82. The study is designed to
evaluate the safety and efficacy of X-82 in the prevention of
vision loss due to wet AMD. A Phase 1 study showed X-82 was able to
maintain or improve vision in all subjects who received the drug
for the six-month study duration, and most subjects did not require
any rescue injections during that time. There were no dose-limiting
toxicities encountered during the study.
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Corporate Contact:Tyrogenex Corporate CommunicationsTeri
Swift, 561-727-9559teri@tyrogenex.comorMedia
Contact:LaVoieHealthScienceDavid Connolly, 617-374-8800 ext.
108dconnolly@lavoiehealthscience.com