Phase
I results for the novel agent phenoxodiol show arrest of disease progression
with minimal toxicity
Phase I clinical trial results of the novel anti-cancer drug phenoxodiol
indicate that it slowed disease progression in 6 of 10 patients at
doses that were well tolerated, according to a presentation at the
annual meeting of the American Association for Cancer Research. The
cancer types represented by the patients in the trial included colon
cancer, melanoma, thymic cancer, and prostate cancer. Toxicity included
moderate nausea, fatigue, and shortness of breath.
Phenoxodiol represents a new
direction for anti-cancer therapy by manipulating apoptosis. When
the process malfunctions in cancer cells, it can prevent normal
cell death or death from chemotherapeutic attack. Phenoxodiol manipulates
initiation of apoptosis through interaction with key molecules in
the control mechanism including sphingosine kinase and the caspase
proteins.
"We are very encouraged
by this early result," said Graham Kelly Ph.D., chairman of
the Australian-U.S. company that is developing the drug. "The
data presented today are consistent with what we've seen in other
trials with phenoxodiol which is stabilization of cancer growth
in some patients without serious toxicity."
"We continue to refine
the search for the optimum dose, the best method of administration,
and the cancer targets that will respond best to phenoxodiol,"
said Dr. Kelly. "But we are exactly where we expected to be
today."
Patients in the trial had a
variety of cancers that had failed to respond to standard chemotherapeutic
agents. The test drug was administered by intravenous infusion for
six weeks. Treatment could be continued past six weeks if there
were no evidence of tumor progression or serious toxicity. Of the
10 patients in the trial, 6 remained on phenoxodiol beyond six weeks
following evidence of stabilization of their disease.
"Phenoxodiol is an interesting
new drug. It may target certain proteins in cancer cells that could
be key to the cancer process," said Thomas Hutson, M.D., the
trial's co-investigator.
"Phase I clinical
trials are mainly about evaluating the safety of new drugs and how
to use those drugs, rather than about whether or not the drug works.
We are encouraged that phenoxodiol was reasonably well tolerated,"
said Ronald Bukowski, M.D., Director of Experimental Therapeutics
at the Cleveland Clinic Taussig Cancer Center, the site of the trial.
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