) recently announced that data from a study on its oncology
candidate, ibrutinib, was published in
The study evaluated ibrutinib's anti-tumor effect in patients
suffering from mantle cell lymphoma (MCL), a form of B-cell
non-Hodgkin lymphoma that generally affects older adults.
The recently published data revealed that the lymphocytes that
increased in the peripheral blood during treatment with ibrutinib
are MCL cells rather than normal cells. The data was in context
to previous study results which showed that after being treated
with ibrutinib, absolute lymphocyte count (ALC) increased in the
peripheral blood in MCL patients.
The recent data further showed that ibrutinib directly and
potently inhibits MCL cell adhesion and relocation in the
existing lymph nodes/tissues. Moreover, other significant changes
in nodal responses and markers of activation and growth were
observed with continued treatment with ibrutinib.
We note that Pharmacyclics is seeking approval for ibrutinib in
the U.S. for the MCL indication as well as for chronic
lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
Pharmacyclics' regulatory submission in the U.S. for ibrutinib
was based on positive results from the company's phase II studies
on the candidate in patients with MCL and relapsed/refractory
CLL/SLL. Ibrutinib enjoys Breakthrough Therapy Designation in the
U.S. for both indications.
Pharmacyclics is co-developing ibrutinib with Janssen Biotech,
Johnson & Johnson
) company. Pharmacyclics has received milestone payments of $200
million under its agreement with Janssen so far. Pharmacyclics is
eligible to receive further payments of up to $625 million under
the agreement. We expect investor focus to remain on the
regulatory status of ibrutinib.
Pharmacyclics presently carries a Zacks Rank #2 (Buy). Meanwhile,
other stocks such as
Gilead Sciences, Inc.
) currently look more attractive with a Zacks Rank #1 (Strong
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