Shares of Baxter International Inc. BAX gained 1.37% (97 cents) to close at $71.64 on June 24, following an update on an ongoing trial that intends to evaluate the safety and optimal dosing level of BAX 335 – an investigational factor IX (FIX) gene therapy used to treat hemophilia B.
Hemophilia B (or Christmas disease) is a rare genetic disorder in which an individual’s blood does not clot properly. The bodies of patients suffering from this disorder are usually unable to produce significant amount of blood-clotting factor IX, which leads to events of prolonged or spontaneous bleeding.
Baxter’s BAX 335 therapy offers a solution for this disorder. The company obtained this gene therapy through the collaboration and subsequent acquisition of Chatham Therapeutics (2014). BAX 335 uses a highly active variant of factor IX, known as FIX-Padua, which is designed to specifically administer lower doses.
Under the trial, seven patients were divided into three separate units based on dosing levels. To date, no patient has developed FIX inhibitors. Some FIX expression was seen in the lowest dose unit.
In the mid dose unit, two patients did not bleed without regular infusions of FIX. One of these patients has retained FIX expression levels of 20%–25% for one year.
In the high dose unit, patients had the highest expression levels. However, the treatment prompted an immune response that subsequently caused the expression to decline. One patient was forced to resume infusions after expression levels crossed 50% at one point.
The primary endpoint of the trial is the safety assessment of a single dose of BAX 335 governed intravenously. Secondary endpoints include determining the optimal dose to achieve reliable therapeutic plasma FIX activity, as well as pharmacokinetics and immune response to treatment.
We believe successful completion of the clinical trial and the subsequent launch of the therapy will aid Baxter to gain better market traction in a growing gene therapy market. This will duly propel growth of its biopharmaceuticals business.
Notably, Baxalta is going to formally debut as an independent Baxter drug spin-off on Jul 1, 2015. Baxalta will emphasize on the development and marketing of innovative biopharmaceuticals. Recently, Baxter’s board of directors approved the spin-off, which had been announced in Mar 2014.
Zacks Rank
Currently, Baxter has a Zacks Rank #3 (Hold). Better-ranked medical stocks at the moment include AMN Healthcare Services AHS, Cancer Genetics CGIX and INC Research Holdings INCR. All the three stocks sport a Zacks Rank #1 (Strong Buy).
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