On Monday August 24, 2015 Shares of Galena Biopharma were able to close the day up 11% after announcing an update for its phase 3 trial known as the “PRESENT” trial. The company announced that the independent data monitoring committee — IDMC — concluded that it would be able to reduce the monitoring of the cardiac toxicity study for this phase 3 trial. Why on earth is this important? Well this key finding is important because other breast cancer studies targeting the HER2 expression have seen some increased toxicity.
The fact that Neuvax continues to see continued safety should give continued hopes to breast cancer patients that desperately need a new form of treatment. The company has stated that early interim data could be shown by the end of 2015 or in early 2016. This interim Analysis could potentially give a huge boost to the share price. Therefore investors should keep their eye on this data as it unfolds within the next year or so.
Who is the body that reviewed this safety data? As mentioned above it is the IDMC. They are a group made up of oncologists, cardiologists, and independent statisticians who are responsible for determining the safety of a trial. They will typically recommend to the company whether the safety of the trial is compromised or can continue to completion. The importance of having this medical body is important in getting an outside perspective, that isn’t bias, in determining whether a drug is safe enough to proceed further into clinical trials.
On Tuesday August 25, 2015 shares of Amgen closed the day down 1% after the company announced the filing for FDA approval of its drug known as etelcalcetide. This etelcalcetide drug targets patients with parathyroid problems that stems from Chronic Kidney Disease — CKD. What do we mean by parathyroid? More specifically the parathyroid problem is known as Secondary Hyperparathyroidism — SHPT.
SHPT occurs when there is an excessive amount of parathyroid hormone secreted by the parathyroid glands. The reason it occurs is because the body attempts to make up for the loss in Calcium that occurs with CKD. SHPT leads to patients having frail bones, muscle pain, and organ damage after dialysis.
Amgen’s drug etelcalcetide could target great opportunity for doctors and CKD patients alike if it is ultimately approved. The reason for this is because the current scope of standard of care doesn’t offer too much convenience for patients. Current therapy for SHPT involves patients having to take a handful of pills every day, which becomes a great nuisance. Well Amgen’s drug can be administered to patients intravenously into the patients blood stream.
Even better etelcalcetide can be given directly after patients receive dialysis. This is because patients with CKD have to go at least three times a week for dialysis anyways. The ability to receive this drug at the same time offers more convenience. In addition patients wont’ have to remember to take a bundle of pills everyday for the rest of their lives.
This NDA was filed with good efficacious results from multiple late-stage clinical trials. More specifically this NDA was filed with positive results from three phase 3 studies. Patients who took Etelcalcetide were able to meet on the primary endpoint for all thee of the phase 3 trials. With this in mind it shouldn’t be too difficult for Amgen to obtain FDA approval for this drug in the coming year.
Ariad Pharmaceuticals (NASDAQ:ARIA) & Baxalta (NYSE:BXLT)
On Friday August 28, 2015 Shares of Ariad Pharmaceuticals closed the day up 40% after rumors surfaced that it had received an offer to possibly be bought out by another pharmaceutical company known as Baxalta. The reason for this potential acquisition is because Ariad already has an approved drug known as Iclusig that treats two types of rare cancers.
The first type of rare cancer is Chronic Myeloid Leukemia — CLL – and the other is acute lymphoblastic Leukemia — PH+ ALL. Both of which are blood cancers that stem from or initiate in the patients bone marrow. In 2014 sales of Iclusig reached as high as $56 million, but this year the drug is estimated to bring in up to $130 million.
Baxalta though is not just buying Ariad only because of Iclusig. In addition to Iclusig Ariad has a phase 1/2 trial using another drug known as brigatinib for non-small cell lung cancer — NSCLC. This drug has already shown a response rate of at least 70% in patients which is very powerful data. Whether the board of both companies can come to some type of buyout agreement remains to be seen, but Ariad is a great stock to own whether or not this buyout takes place anyways.