strative expenses of approximately $4 million.
Including share-based compensation expense, Pharmacyclics projects total
operating expenses of between $16 and $17 million for fiscal year 2009,
including general and administrative expenses of approximately $5 million.
Financial projections involve a high level of uncertainty due to, among
other factors, the variability involved in predicting requirements of early
stage research programs and clinical trials, the potential for entering
into partnering arrangements or strategic collaborations, the timing of
U.S. Food and Drug Administration (FDA) decisions and share-based
"We continue to advance our pipeline of novel product candidates with
our HDAC inhibitor moving into a Phase 2 trial for treatment of lymphomas
and the filing of an IND for our Factor VIIa inhibitor," said Richard A.
Miller, M.D., president and chief executive officer of Pharmacyclics.
"Enrollment in two Phase 2 trials with motexafin gadolinium for adult brain
tumors and childhood gliomas also continues under sponsorship of the
National Cancer Institute and we are planning to conduct a pivotal Phase 3
trial with motexafin gadolinium in patients with brain metastases from lung
cancer. Our strategy is to build value in these multiple products as we
progress with their development."
Recent and Upcoming Milestones
* Initiated a multicenter Phase 2 trial evaluating oral HDAC
inhibitor, PCI-24781, in hematologic malignancies.
* Announced final data from a Phase 1/2 study showing a 46 percent
complete response rate and a 57 percent overall response rate in 28
patients with multiply recurrent non-Hodgkin's lymphoma (NHL) who
were treated with motexafin gadolinium (MGd, Xcytrin(R)) in
combination with Yttrium-90 Ibritumomab Tiuxetan (Zevalin(TM)), an
approved antibody-targeted radiation therapy.
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