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To: acuransx_2000 who wrote (547)	1/8/2002 7:51:35 AM
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PCYC, Pharmacyclics Announces Phase III Clinical Trial Results Indicate Xcytrin Improves Neurologic Function in Lung Cancer Patients With Brain Metastases SUNNYVALE, Calif., Jan 8, 2002 /PRNewswire via COMTEX/ -- Pharmacyclics, Inc. (Nasdaq: PCYC chart, msgs) will provide additional results from its Phase III clinical trial of lead product, Xcytrin(R) (motexafin gadolinium) Injection, indicating its potential utility in lung cancer patients with brain metastases (i.e., lung cancer that has spread to the brain) at the 20th Annual JPMorgan H&Q Healthcare Conference in San Francisco. The company will also announce preliminary results of a Phase II clinical trial of Xcytrin in glioblastoma multiforme (GBM, i.e., primary brain tumor) that will lead to initiation of a pivotal Phase III trial in GBM in the first half of 2002. "Results from the ongoing analysis of the data from the Phase III trial appear to indicate that Xcytrin improves local tumor control and neurologic function in lung cancer patients with brain metastases, which makes up to 60 percent of the total market for this disease," said Richard A. Miller, M.D., Pharmacyclics' president and chief executive officer. "We will complete our data analyses and meet with the FDA as soon as possible. We also plan to prepare a New Drug Application to submit as soon as possible based on the outcome of that meeting. We will continue to study Xcytrin in other tumor types, including a Phase III trial in primary brain tumors and ongoing studies with the National Cancer Institute in brain tumors, non-small cell lung cancer and pancreatic cancer. We are in a strong financial position with $142 million in cash as of the most recently reported quarter." The company's randomized controlled trial was conducted at more than 50 leading cancer centers in the United States, Canada and Europe and enrolled 401 patients; 251 with lung cancer, 75 with breast cancer and 75 with other tumor types. It was designed to compare the safety and efficacy of standard whole brain radiation therapy (WBRT) to standard WBRT plus Xcytrin. The prognosis and response to therapy of patients with brain metastases is dependent on tumor type and extent of tumor spread within the body. Therefore, the study had co-primary efficacy endpoints of survival and time to neurologic progression and the pre-specified statistical analysis plan called for stratification and data analysis based on tumor type: lung, breast or others and extent of disease, i.e., RPA class. As previously reported, there was not a statistically significant difference observed in overall survival or time to neurologic progression for all patients. There was significant improvement in time to neurologic progression in lung cancer patients receiving Xcytrin. In these patients, median time to neurologic progression was 7.4 months for the control group and exceeded 12 months for the Xcytrin-treated group (unadjusted p=0.048). For RPA Class II lung cancer patients (n=214), also a pre-specified strata, the median time to neurologic progression was 6.3 months for the control group and again exceeded 12 months for the Xcytrin-treated group (unadjusted p=0.013). A further analysis of this data shows that progression-free survival at one year was 18.6 percent in Xcytrin-treated patients compared to 10.5 percent in the control group. An independent Events Review Committee that was blinded to the treatment assignment determined neurologic progression based on several objective and quantitative clinical assessments. Newly available secondary endpoint data on neurocognitive function confirm Xcytrin's apparent ability to control tumor progression in lung cancer patients. This is the first trial of its kind to comprehensively and objectively evaluate brain function using a battery of six different standardized neurocognitive tests including memory and executive function (i.e., the ability to reason and make decisions). There was a significant improvement in time to neurocognitive progression across all of these tests in favor of the Xcytrin-treated lung cancer patients versus control (p=0.046). The relative risk of a neurocognitive progression was 81 percent greater for the control patients than for the Xcytrin-treated patients (i.e., hazard ratio of 1.81; 95 percent confidence interval of 1.01-3.25). The Phase III trial also showed Xcytrin to be well tolerated. The most commonly reported side effects were transient skin discoloration, nausea and mild diarrhea. The company is still in the process of evaluating all the data from the trial and plans to report the findings at the Annual Meeting of the American Society of Clinical Oncology next May. Xcytrin in Primary Brain Tumors Updated results of a Phase I dose-escalation trial to assess the safety and tolerability of Xcytrin for the potential treatment of primary brain tumors (i.e., glioblastoma multiforme, GBM) were presented last month at the Annual Meeting of the American Society of Therapeutic Radiation Oncology. In this trial, Xcytrin was well tolerated and median survival for the first 28 patients is 16.8 months, which compares favorably to a median survival rate of about 10-11 months reported in the literature for a similar patient population. Among the limited number of side effects observed were non-dose related rash and finger blisters. Pharmacyclics recently completed enrollment in a 25-patient Phase II study in GBM. A preliminary analysis of this data so far confirms the results observed in the Phase I trial. As a result, the company plans to initiate a pivotal Phase III trial in GBM by the end of the first half of this year. Other studies now underway with Xcytrin include those being performed under a cooperative research and development agreement with Pharmacyclics and the National Cancer Institute for the treatment of non small-cell lung cancer, glioblastoma multiforme, childhood gliomas (life-threatening brain tumors in children) and pancreatic cancer. Several other trials in other cancer types are in the planning stages. The company also will initiate a Phase I trial to investigate Xcytrin's potential to enhance the effects of chemotherapy, specifically doxorubicin in the first quarter of 2002. Webcast Details Dr. Miller will present at the 20th Annual JPMorgan H&Q Healthcare Conference in San Francisco today at 11:00 a.m. PST in the Elizabethan A&B Room. The presentation will be webcast live and archived for 60 days and can be accessed at www.eventsdigital.com/events/jpmhq/healthcare2002 or by logging onto the investor section of the company's web site at www.pcyc.com.