Corporate News Blog – Puma Biotech Announced Positive Results from PB272 Phase-II Data at the ASCO, 2017

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LONDON, UK / ACCESSWIRE / June 6, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for biopharmaceutical firm Puma Biotechnology, Inc. (NASDAQ: PBYI) (“Puma”). The Company announced on June 03, 2017, the presentation of positive results from an ongoing Phase-II clinical trial, (Translational Breast Cancer Research Consortium TBCRC 022) of Puma’s investigational drug PB272 (neratinib) for the treatment of HER2-positive metastatic breast cancer that has metastasized to the brain. The Company presented the data at the oral presentation at the Americal Society of Clinical Oncology 2017, annual meeting in Chicago, Illinois. For immediate access to our complimentary reports, including today’s coverage, register for free now at:

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Phase-II Clinical Trial

On May 17, 2017, the Company announced the release of an abstract on its drug candidate PB272 (neratinib) and specified that it will be presented at the ASCO Annual Meeting, to be held June 02-06, 2017. The multicenter Phase-II trial is being performed by the TBCRC and has enrolled patients in three different cohorts. Patients in the first cohort, or n=40, included the ones who had progressive brain metastases who were administered neratinib monotherapy. The Company reported data from this cohort previously at the 2014 ASCO Annual Meeting and the result was published in the Journal of Clinical Oncology in 2016.

The second cohort (n= 5) represented the patients who had brain metastases, which were amenable to surgery and were administered neratinib monotherapy prior to and after surgical resection. The third cohort (target enrollment= 60) enrolled two different subgroups of patients, namely prior lapatinib-treated and no prior lapatinib-treated, with progressive brain metastases who were administered neratinib in combination with a chemotherapy drug, capecitabine.

The oral presentation was based only on the patients in the third cohort of patients without a prior lapatinib exposure, (cohort 3A) where all the patients had progressive brain metastases at the time of enrollment and received the combination of capecitabine and neratinib. In cohort 3A, 30% of the patients had received prior craniotomy, while 65% of the patients had received prior whole brain radiotherapy. Additionally, 35% of the patients had received prior stereotactic radiosurgery to the brain. No patients, however, had received prior treatment with lapatinib.

Results

The results of the cohort 3A represented that the most frequently observed, severely adverse outcome for the 37 patients evaluable for safety was diarrhea. Hence, patients received antidiarrheal prophylaxis, consisting of high dose loperamide, delivered in conjunction with capecitabine plus neratinib for the first cycle of treatment, in an attempt to reduce neratinib-related diarrhea. According to the Company, this activity viewed in the trial with a combination of neratinib plus capecitabine offers a viable treatment to patients, suffering from brain metastases. As a small molecule, that can cross the blood-brain barrier, neratinib potentially offers patients with HER2-positive metastatic breast cancer that have metastasized to the Central Nervous System (CNS), a novel HER2 targeted treatment option. The Company plans to work forward with the TBCRC on future trials of neratinib in patients with HER2-positive disease metastatic to the CNS.

Company Growth Prospects

Puma Biotechnology is a leading firm, focusing on development and commercialization of innovative products to enhance cancer care. The Company in-licenses the global development and commercialization rights to three drug candidates – PB272 (neratinib (oral)); PB272 (neratinib (intravenous)); and PB357. Currently, Puma Biotechnology is focused on the development of the oral version of neratinib, as it is the most advanced drug candidates directed at the treatment of HER2-positive breast cancer. The Company expects to utilize neratinib in the treatment of several other cancers, including non-small cell lung cancer and other tumor types that have a mutation in HER2.

Last Close Stock Review

On Monday, June 05, 2017, the stock closed the trading session at $83.65, climbing 2.07% from its previous closing price of $81.95. A total volume of 4.93 million shares have exchanged hands, which was higher than the 3-month average volume of 1.58 million shares. Puma Biotech’s stock price soared 128.86% in the last one month, 111.77% in the past six months, and 131.01% in the previous twelve months. Furthermore, since the start of the year, shares of the Company have skyrocketed 172.48%. The stock currently has a market cap of $3.08 billion.

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