July 9, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Restricted letters from France’s National Agency for Drug Safety (ANSM) were recently released concerning French-based AB Science’s clinical trials of masitinib.
In 2012, the ANSM halted nine clinical trials being conducted by Paris-based AB Science, which also had U.S. headquarters in Chatham, N.J. The drug, masitinib, was being studied for Alzheimer’s disease, severe asthma, chronic obstructive pulmonary disease (COPD), multiple sclerosis (MS), rheumatoid arthritis and painful bladder syndrome. The letter stated, “There is an increased risk of serious and severe adverse events that have the potential to be fatal.”
Several other countries, including the U.S., have allowed study of the drug. “It’s not rare for regulators, and it’s their prerogative, to have diverging opinions on molecules that are in early-stage development for both oncology and other areas,” said Laurent Guy, chief financial officer of AB Science in an email to Bloomberg Business. “Further development will bring final responses about masitinib’s efficiency and the balance between benefit and risk for each type of illness.” It’s unclear if Guy meant “efficacy” instead of “efficiency.”
On July 2, 2015, AB Science announced that the independent Data and Safety Monitoring Board (DSMB), based on three ongoing Phase II studies of masitinib, had recommended progression into Phase III development for masitinib. The three studies include a Phase II study for the treatment of advanced hepatocellular carcinoma, Phase II to evaluate the safety and efficacy of masitinib in metastatic or locally advanced breast cancer in combination with gemcitabine or carboplatin or capecitabine, and a Phase II study for safety in head and neck squamous cell carcinoma in combination with irinotecan or masitinib in combination with gemcitabine.
Masitinib is an oral version of a tyrosine kinase inhibitor. It targets mast cells and macrophages, which are involved in inflammation, and appears to have positive effects on symptoms associated with some inflammatory and central nervous system diseases.
AB Science is working toward 13 Phase III studies of masitinib, including first-line and second-line GIST, metastatic melanoma, multiple myeloma, metastatic colorectal cancer, prostate cancer, pancreatic cancer, asthma, and several other diseases.
Since the ANSM decision, AB Science made changes to its clinical trials, with particular focuses on toxicity in cancer treatments. Typically, doses of masitinib is administered in much higher dosages in cancer treatment than in autoimmune and inflammatory studies.
In France, the only non-cancer trial of masitinib is for mastocytosis, a rare immune system disorder. In the European Union the drug has been rejected for the treatment of pancreatic and stomach cancers. It continues to be studied in several EU countries and the U.S. for Alzheimer’s, asthma, MS and rheumatoid arthritis. It is being studied in COPD only in Spain, which is the only country to have approved trials for acute ischemic stroke, depression and progressive supranuclear palsy.
AB Science’s shotgun approach is unusual, in that it has apparently solely studied a single compound in more than 20 diseases. To date, masitinib has only been approved to treat cancer in dogs. “They have an unusual way of operating,” said Jean-Yves Blay in a Bloomberg Business article. He is an oncologist and managing director of the Centre Leon Berard in Lyon, France and no longer works on AB Science’s clinical studies. “The methods and the means used were not those usually applied for registration trials.”
In addition, to save costs, the company monitors clinical trials itself rather than hiring contractors, which has some critics concerned that the company’s science is not rigorous enough. The European Medicines Agency, the ANSM and the U.S. Food and Drug Administration (FDA) have all had issues with the company’s approach at one time or another, including a warning letter from the FDA in 2014 over marketing concerns.
The company stock has an uneven history. Shares traded for $7.31 on Oct. 16, 2014, rose to $17.72 on Feb. 10, 2015, and dropped to $14.67 on May 5. It rose to $17.62 on June 1 and is currently trading for $14.28.
As New Jersey Biotech Booms, Will It Overtake Other States As Prime Location?
A week after Celgene Corporation announced it is officially the mystery buyer of Merck & Co. ’s former 1 million-square-foot R&D site in Summit, N.J., it quickly became our most popular story last week.
The company announced last Wednesday that it is buying the space, ending months of speculation about what Big Pharma company might move into the neighborhood.
The Summit, N.J. site is zoned research/office. The New Jersey site would put operations closer to some of the major biotech and pharmaceutical hubs on the East Coast.
But, by far, the most tempting part of doing business in the state remains New Jersey’s operating tax credit, which allows companies to sell their net operating losses to the New Jersey Treasury. One of the state’s most recognizable biotechs, Celgene, used the program until it became profitable, which was key to it staying in the state, said local officials.
That has BioSpace is wondering if New Jersey is becoming the new face of biotech. What do you think? Can the Garden State compete with other longtime stalwarts like California or Boston?
