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Pfizer Announces Third-Time Study Results Supporting the Safety of Protegene Injections for Treatment Prostate Cancer
Prostate Cancer Treatment Success with Prostaglandin E1-Protein (PEP) Injection Injectable
San Diego, Calif. (January 30, 2017) -- Pfizer Inc. (NYSE,Nasdaq:PFE) today announced results of a third-time, patient-centered study PEP-injected Prostate Cancer (PC) patients in the U.S. showing a statistically significant improvement in the rate of symptomatic response to PEP in this previously unmet need.
"We have witnessed incredible support among PC patients treated with PEP to prevent recurrence," said Thomas E. O'Donoghue, M.D., president, Pfizer Inc. "We look forward to continuing these studies explore the possible value of PEP injections to treat PC more effectively." Dr. O'Donoghue also noted that PEP treatment is now available on a compassionate use basis for U.S. patients with metastatic prostate cancer.
The study included 1,021 PC patients treated with PEP at the Mayo Clinic between August 2015 and 2017. The study, evaluating PEP therapy for PC, was performed between the Mayo Clinic in Rochester, Minnesota and the Mayo Clinic in Phoenix, Arizona. The study included patients with metastatic/recurrent PC between the ages of 49-81 years. primary endpoint was change from baseline in the Prostate Cancer Symptom Rating Scale (PC-SRS) to the revised score of 0 to 100. Secondary endpoints included survival and adverse event information.
In this study group, there was a statistically significant improvement in the progression-free survival (PFS), defined as time to progression, of PC patients treated with PEP to treat symptoms associated with the disease. There were no significant differences between the two study sites in primary or secondary endpoints from baseline to last follow-up. The study group received PEP in
Buy generic propecia online doses greater than 4.5 mg in 75% of patients; a higher dose was used for patients with the greatest benefit compared to lowest dose. Overall, there was no significant differences between the four study sites in rate of adverse events or deaths.
Pfizer recently announced the results of a previously conducted study to determine the safety of PEP therapy in PC. The study demonstrated that in one of the study sites, PEP injections are safe and well tolerated in patients younger than 75 years and older 81 years, in both men and women under the age of 50 years. This study demonstrated that in the first three months after infusion, the PEP injections had no clinically meaningful adverse effects. Further, most event rates and serious adverse events (defined as an event resulting in the patient requiring transfer to a healthcare facility) for PEP-injected PC patients in this study did not differ based on treatment arm or sex.
About Prostate Cancer
PC -- or PSA, PSA-based serum PSA -- is an important risk factor for prostate cancer diagnosis. Approximately half of all new cases prostate cancer result from PC. PC increases the risk of developing other serious and often fatal cancers in your body, including lung, colorectal, pancreatic, brain.
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