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TNI BioTech Acquires Exclusive License To The Portfilio Of Patents Of Dr Ian S. Zagon, Dr. Patricia J. McLauglin And Dr. Jill Smith From The Penn State Research Foundation
Date:2/1/2013

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Summary of Clinical Trial on the Benefits of OGF in the Treatment of Pancreatic Cancer

In a prospective phase II open-labeled clinical trial performed by Dr. Jill Smith and her colleagues in the Departments of Medicine, Public Health Sciences, Pathology, and Neurosciences and Anatomy at the Pennsylvania State University School of Medicine in Hershey, PA, patients with very advanced pancreatic cancer were treated. These patients had failed prior chemotherapy regimens and were either treated weekly with opioid growth factor (OGF) or entered a hospice program.

Results: Clinical benefit response was experienced by 53% of OGF-treated patients compared to historical controls of 23.8% and 4.8% for gemcitabine and 5-fluorouracil (5-FU), respectively. Of the OGF-treated patients surviving more than eight weeks, 62% showed either a decrease or stabilization in tumor size by computed tomography. The median survival time for the OGF-treated patients was three times that of the untreated hospice patients (65.5 versus 21 days, p < 0.001). No adverse effects on hematologic or chemistry parameters were noted, and quality of life surveys suggested improvement with OGF.

Limitations: Measurements other than survival were not allowed in the control hospice patients, and clinical benefit comparisons were made to historical controls.

Conclusion: OGF biotherapy improves the clinical benefit and prolongs survival in patients with pancreatic cancer by stabilizing disease or slowing progression. The effects of OGF did not adversely alter the patients' quality of life. The use of OGF biotherapy at earlier stages of disease or in combination with chemotherapeutic agents may further improve the outcome of this malignancy.

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