Last $228.38 USD
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puma biotechnology inc (PBYI) Snapshot

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08/26/14 - $279.37
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puma biotechnology inc (PBYI) Details

Puma Biotechnology, Inc., a development stage biopharmaceutical company, focuses on the acquisition, development, and commercialization of products to enhance cancer care. Its drug candidates include PB272 (neratinib (oral)) for the treatment of advanced breast cancer patients, non-small cell lung cancer patients, and patients with HER2 mutation-positive solid tumors; and PB272 (neratinib (intravenous)) for the treatment of advanced cancer patients. The company is also developing PB357, an orally administered agent that is an irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2, and HER4. It has a license agreement with Pfizer, Inc. for the development, manufacture, and commercialization of neratinib (oral), neratinib (intravenous), PB357, and related compounds. Puma Biotechnology, Inc. was founded in 2010 and is headquartered in Los Angeles, California.

97 Employees
Last Reported Date: 08/11/14
Founded in 2010

puma biotechnology inc (PBYI) Top Compensated Officers

Founder, Chairman of The Board, Chief Executi...
Total Annual Compensation: $806.7K
Principal Financial Officer, Principal Accoun...
Total Annual Compensation: $366.4K
Senior Vice President of Clinical Research an...
Total Annual Compensation: $433.0K
Senior Vice President of Regulatory Affairs, ...
Total Annual Compensation: $375.2K
Compensation as of Fiscal Year 2013.

puma biotechnology inc (PBYI) Key Developments

Puma Biotechnology Announces Positive Initial Results from PB272 Phase II Trial in HER2 Mutated Non-Small Cell Lung Cancer

Puma Biotechnology, Inc. announced that positive initial data from the ongoing, open label Phase II clinical trial of its investigational drug PB272 (neratinib) for the treatment of patients with non-small cell lung cancer (NSCLC) with HER2 mutations was presented as a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) 2014 Congress, taking place in Madrid, Spain. In the trial, patients with confirmed stage IIIB or stage IV NSCLC with documented somatic HER2 mutations were randomized to receive either oral neratinib monotherapy at a dose of 240 mg per day or the combination of oral neratinib (at a dose of 240 mg daily) with intravenous temsirolimus administered at a dose of 8 mg per week. In order to attempt to reduce the neratinib related diarrhea, high-dose loperamide prophylaxis (Imodium) was given to all patients in both arms of the study beginning on day 1 of neratinib dosing. The data presented in the oral presentation involved a total of 27 patients who completed the first stage of the trial; 13 of these patients received neratinib monotherapy and 14 of these patients received the combination of neratinib plus temsirolimus. The results of the study showed that the combination of PB272 and temsirolimus had acceptable tolerability. Historically the most frequently seen adverse event associated with neratinib has been diarrhea. In the previous Phase I trial of neratinib plus temsirolimus (J Clin Oncol 2014) the diarrhea with neratinib was seen to be dose dependent and its incidence increased with increasing neratinib dosage. In that Phase I trial, grade 3 or higher diarrhea was seen in approximately 30% of the patients treated with doses of neratinib that were 200 mg or higher. In this Phase II study, all patients received high-dose loperamide in order to attempt to prevent or reduce the neratinib-related diarrhea. For the 13 patients enrolled in the neratinib monotherapy arm, 1 (8%) patient experienced grade 3 diarrhea, and for the 14 patients enrolled in the combination of neratinib plus temsirolimus arm, 2 (14%) patients experienced grade 3 diarrhea. There were no grade 4 diarrhea events seen in the trial. For the 3 patients in the study (1 in the monotherapy arm, 2 in the combination arm) who experienced grade 3 diarrhea, 2 of the 3 patients were not compliant with the loperamide prophylaxis regimen and were not taking loperamide at the onset of grade 3 diarrhea. The efficacy results from the trial showed that for the 13 patients in the trial who received neratinib monotherapy, no patient experienced a partial response, 7 (54%) patients achieved stable disease and 4 (31%) patients achieved clinical benefit (defined as a partial response or stable disease for 12 or more weeks). For the 14 patients who received the combination of neratinib plus temsirolimus, 3 (21%) patients experienced a partial response, 11 (79%) patients experienced stable disease and 9 (64%) patients achieved clinical benefit. The median progression free survival of the neratinib monotherapy arm was 2.9 months and the median progression free survival of the arm that received neratinib plus temsirolimus was 4.0 months. Patients continue to be enrolled in the arm of the trial that is receiving the combination of neratinib plus temsirolimus.

Puma Biotechnology, Inc. Announces Board Changes

On August 27, 2014, Dr. Richard B. Phillips, Senior Vice President, Regulatory Affairs, Quality Assurance and Pharmacovigilance, notified Puma Biotechnology, Inc. that he will be retiring for health reasons effective during the fourth quarter of 2014 (and no later than November 7, 2014). Effective upon Dr. Phillips' departure, his regulatory responsibilities will be assumed by Erin Jones, the company's current Vice President, Global Regulatory Affairs. Prior to joining Puma, Mr. Jones worked at Genentech, where he held a variety of positions including North America Oncology Team Leader.

Puma Biotechnology, Inc. Presents at Citi's 9th Annual Biotech Conference, Sep-03-2014

Puma Biotechnology, Inc. Presents at Citi's 9th Annual Biotech Conference, Sep-03-2014 . Venue: The Mandarin Oriental Boston, 776 Boylston Street, Boston, MA 02119, United States.


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