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Pre-clinical Studies Demonstrate that the Excipients Enhanced the Anti-inflammatory Effect of Methotrexate (MTX)
July 30, 2007
Can-Fite BioPharma, a biotechnology company traded on the Tel Aviv
Stock Exchange reports that laboratory trials have proven that the
excipients included in the placebo used in its trial in combination
with the drug MTX improves the drug's performance in treating
rheumatoid arthritis. Can-Fite lately reported the results of a Phase
IIb clinical trial that had evaluated the safety and efficacy of a
combination of CF101 and MTX in treating rheumatoid arthritis patients.
A high number of patients (50%) responded with a 20% improvement in the
disease indices (ACR20), both in the control group and in groups that
had been treated with CF101 in combination with MTX. This percentage of
responders in the control group is an unprecedented phenomenon, and is
higher than that which has thus far been described in the literature.
As a result, Can-Fite conducted the trials with the drug excipient and,
indeed, found that it had acted as an anti-inflammatory substance and
significantly enhanced the MTX drug efficacy.
The company's scientists have conducted pre-clinical laboratory studies
with models simulating rheumatoid arthritis. These studies proved that
the excipient in the placebo has biological activity that, in
combination with the MTX, produces an anti-inflammatory effect. The
excipient is an oil mixture containing Polyoxyl 45 Castor Oil and
Miglyol 812. The aforementioned laboratory studies conducted by
Can-Fite revealed that the excipients enhanced the anti-inflammatory
activity of the drug methotrexate (MTX). In pre-clinical laboratory
trials, Can-Fite scientists found that the excipients led to
up-regulation of the 2 adenosine receptors, A3 and A2A which are known
to mediate the effect of MTX. This finding explains the high activity
observed in a group treated with MTX and placebo (the control group).
These results explain the high percentage of control group patients whose condition had improved.
As reported earlier, Can-Fite has applied for a patent that protects
the biological activity of the excipient, and is even considering its
development of the solvent as a supplement to the current rheumatoid
It should be noted that Can-Fite reported a significant improvement in
the percentage of patients who had responded with a 50% and 70%
improvement as well as in the EULAR 'Good' Response Score. Another
important finding was that the patient response improvement had
increased throughout the treatment period, indicating that a long-term
trial would make it possible to observe continued improvement. The
results further reveal that, in all the indices, the 1mg dose of CF101
was the most efficacious, a result which is important for the future
drug development program. It should also be noted that the treatment
combining CF101 and methotrexate had a high safety profile.
Prof. Pnina Fishman stated that the discovery that the excipient has
significant biological activity that modulate the expression of the
adenosine receptors on the surface of the inflammatory cells led to
enhancement of the methotrexate activity. These results, for which
Can-Fite registered a patent, can serve as a basis for developing
another product for the benefit of those suffering from this disease.
Can-Fite Biopharma Ltd is a public company traded on the Tel-Aviv Stock
Exchange. The Company, which commenced business activity in 2000, was
founded by researcher Prof. Pnina Fishman and patent attorney Dr. Ilan
Cohn. The Company focuses on the development of small molecule-based
drugs which target the A3 adenosine receptor and inhibit the
development of cancer or inflammatory cells. The market for the
company's drugs is estimated at billions of dollars.
Can-Fite develops targeted drugs that specifically
attack affected cells without compromising normal body systems, and
therefore have a favorable safety profile. The Company's drugs are
based on a scientific concept, which was proven in trials, suggesting
that the A3 adenosine receptor, the target of the drug is only
expressed on the surface of affected cells. The Company has recently
developed a procedure that uses pre-treatment blood tests to determine
the receptor level, which may be indicative of treatment response.
The Company's lead drug, CF101 has completed a
multinational study in the treatment of rheumatoid arthritis and plans
to continue to develop the drug for this indication. CF101 is also in
clinical development for two other indications: Dry Eye Syndrome, for
which a Phase II study is ongoing and Psoriasis where a Phase II study
has recently started. The Company is also developing another small
molecule drug, CF102, for treatment of liver cancer and hepatitis.
CF102 is in pre-clinical development and the development is on target
for filing an IND towards the end of this year and the onset of Phase I
study shortly thereafter. The company also has a number of other small
molecule drugs in earlier stages of development.
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