AbbVie Inc. (ABBV, Financial) announced Tuesday through PR Newswire that results indicate ibrutinib (trade name Imbruvica), a type of chemotherapy drug for the treatment of patients suffering from “chronic graft-versus-host disease (cGVHD),” is effective and safe.
Previously, these patients underwent a “systemic therapy” based on “high dose glucocorticoids” that were unsuccessful, the company said.
According to the National Cancer Institute, a systemic therapy is a “treatment using substances that travel through the bloodstream, reaching and affecting cells all over the body.”
Graft-versus-host disease (GvHD) is a reaction that develops in response to a transplant in which the donor and the recipient of bone marrow are not the same person. Alternatively, if it is necessary for the patient to undergo a treatment that damages the bone marrow cells, the patient can choose a procedure in which his/her cells are withdrawn to be reinfused after the treatment.
The bone marrow cells are important components of the immune system. In GvHD, the transplanted cells react to the recipient cells (host) because the first recognize the second as foreign cells which are therefore attacked. Hence the name of the condition.
GvHD is a common reaction after a bone marrow transplant, but it stops after the transplanted cells have established themselves in the recipient’s body.
Theare two forms of graft-versus-host disease: acute and chronic.
Chronic GvHD develops over a longer period than the acute GvHD. The main cause of the chronic GvHD is the same as in the acute form of the disease: the mismatch between the stem cells and bone marrow of the donor and recipient. However, the reaction is less severe in the chronic form.
Individuals suffering from chronic GvHD may not develop symptoms for several months. The symptoms sometimes do not occur for several years. Chronic GvHD can affect any part of the body.
The Phase 2 study’s results were announced in San Diego during the Annual Meeting and Exposition of the 58th American Society of Haematology.
After having treated these patients with ibrutinib (Imbruvica) for a 14-month period the researchers found that 28 patients out of the total of 42 responded to the treatment. Nine patients of those who responded to the treatment obtained a “complete response,” 20 responders “experienced a sustained response,” and analogous results were observed in all affected organs, even in patients with more than two organs affected by the disease, the company says.
During the overall trial, 17 responders showed a significant abatement of the illness’ signs. Furthermore, 26 patients could decrease steroid use to a tolerable dosage while 12% of all patients could quit taking steroids.
Concerning the data collected by the researchers to assess the safety of the treatment, the company says that they did not diverge those data collected from patients “treated with ibrutinib for B-cell malignancies and in patients with cGVHD on corticosteroids.”
Imbruvica is a Bruton's tyrosine kinase inhibitor. Bruton's tyrosine kinase is an enzyme that plays an important role in the development of the B cells, which are lymphocytes, a class of white blood cells.
AbbVie says that “’the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation and Orphan Drug Designation in June 2016 for ibrutinib as a potential treatment for cGVHD after failure of one or more lines of systemic therapy.”
AbbVie closed at $60.91 Thursday, up 92 cents (or 1.53%) from the previous close.
AbbVie has a market capitalization of $98.98 billion and approximately 1.63 billion shares outstanding, of which 0.10% are held by insiders and 73.60% are held by institutions. The volume of shares freely traded on the New York Stock Exchange is 1.62 billion.
According to current market prices, AbbVie is trading at 15.30 times its book value per share (mrq) and 11.58 times its EBITDA.
Most analysts suggest holding the stock, and the average target price is $69.95, up 20 cents or 0.29% from Tuesday.
NWQ Managers (Trades, Portfolio), Joel Greenblatt (Trades, Portfolio), David Dreman (Trades, Portfolio), Mario Gabelli (Trades, Portfolio) and Ken Fisher (Trades, Portfolio) reduced their positions in AbbVie by 73.90%, 24.43%, 5.52%, 42.78% and 1.35%.
Disclosure: I have no positions in AbbVie.
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