Onyx Pharmaceuticals it is all in the black….:)

Onyx Pharmaceuticals has a lot of clinical trials going on and development of drugs in the hopper.

Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) announced today in Blood, the medical journal of the American Society of Hematology, has published their results from the 003-A1 Phase 2b trial, a single-arm, multicenter clinical trial evaluating Kyprolis(TM) (carfilzomib) for Injection for the treatment of patients with advanced multiple myeloma, who had received a median of five prior anti-myeloma regimens.
The lead author was Dr. David Siegel, Chief of the Division of Multiple Myeloma at John Theurer Cancer Center at Hackensack University Medical Center (http://www.marketwatch.com/story/onyx-pharmaceuticals-announces-kyprolistm-study-published-in-the-medical-journal-blood-2012-07-25)

Several Phase III clinical trials will begin soon for treatment of myeloma. One of the trial is called FOCUS trial which is evaluating Kyprolis, and the other is called ENDEAVOR, which is evaluating the combination of Kyprolis and low-dose dexamethasone versus  bortezomib and low dose dexamethasone.

So many of you may not have a clue on what these drugs are, so let me try to enlighten you a bit.

Kyprolis is also called carfilzomib. It is an epoxyketone-based proteasome inhibitor and may reduced tumor burden and inhibits bone destruction.  It turns out that kyprolis inhibits the formation of osteoclasts. Osteoclasts are cells in your bone that break down bone and remodel bone; all of which are normal functions occurring in bone.  In fact, it is suggested that kyprolis is actually shifting the microenvironment from catabolic to anabolic (bone formation). This will inhibit a tumors ability to survive in a bone environment. It also makes me wonder whether this may be useful for people with osteoporosis. We will have to see if Onyx goes in that direction too.

Bortezomib is also called Velcade and PS-341 and is a boronic acid dipeptide derivative that is a potent inhibitor of the proteosome. Inhibition of proteosome function leads to accumulation of misfolded proteins in the cell and results in endoplasmic reticulum stress.  All of these things can lead to cell death, which is bad news for the tumor cells good news for the patients.

According to Scottrade,  Onyx is developing therapies that target the molecular mechanisms that cause cancer. They have two franchise platforms: one in kinase inhibition and one in proteasome inhibition. In its kinase inhibitor franchise, its product, Nexavar (sorafenib) tablets is approved for unresectable liver cancer, advanced kidney cancer, unresectable liver cancer and advanced kidney cancer. With its development and marketing partner Bayer HealthCare Pharmaceuticals Inc., or Bayer, the Company shares equally in the profits and losses of Nexavar worldwide except Japan. A kinase inhibitor, regorafenib, is an investigational agent that has already demonstrated positive Phase 3 survival data in metastatic colorectal cancer, and is being evaluated in a Phase 3 study in gastrointestinal stromal tumors (GIST) (compliments of Scottrade). It does seem to me that Scottrade needs to update what is going on…

What about the stock?

Its year to date performance is up 74% among its peer.  However Thomson Reuter has a negative rating on Onyx, while the second Opinion Weekly reported an upgrade to 0 (improving) 94 days ago.

Below is the stock’s chart, suspiciously (?) the stock has almost doubled since just before July.  I wonder who go the news early. Too bad we didn’t get in then.  Do I think the stock is going to keep increasing? Yes, perhaps into the 80’s. I recommend keeping this stock for the long run, but don’t expect it to double in the near future.

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