Japanese Pharmaceutical Company Aims to Develop Lower-Dose Actos into Alzheimer’s Treatment
Takeda Pharmaceuticals and their partner, Zinfandel Pharma, have started a Phase III trial of Actos – generically known as pioglitazone – in people who are at risk of developing Alzheimer’s disease.
The phase III trial, known as the TOMMORROW trial, will simultaneously assess a low dose of Actos and a risk-assessment algorithm designed to identify patients at risk of developing mild cognitive impairment (MCI) due to Alzheimer’s disease. The algorithm assesses two biomarkers – the ApoE gene as well as another marker called TOMM40 – which have been shown to have positive and negative prediction values.
Prior studies into using Actos in symptomatic Alzheimer’s patients showed only a small benefit to those taking the drug, so both Takeda and Zinfandel are looking to applying the drug in a more preventative manner, hoping that Actos works on some symptoms of the disease to delay progression.
Actos is thought to work by decreasing brain inflammation, which is a novel approach to early-stage Alzheimer’s patients. Other clinical-stage drugs are designed to interrupt the formation of amyloid plaques, but they have not been shown to be effective.
“To date, there have been a number of avenues investigated with the goal of altering the course of Alzheimer’s disease but results have been unsuccessful,” said Zinfandel’s chief executive Allen Roses.
“The potential to identify an individual’s risk for developing MCI due to AD warrants further investigation,” he added.
Actos Personal Injury Lawsuits Claim Link to Bladder Cancer
Although the new Alzheimer’s clinical trials use a lower dose of Actos, the choice is still unusual. The drug has come under a lot of fire recently for being linked to an increased risk of bladder cancer, along with other chronic diseases, in patients who took a higher dose of Actos to treat their Type 2 diabetes. This could be Takeda Pharmaceutical’s attempt to regain patent protection for their blockbuster drug, which they lost in 2011. Generic Actos, called pioglitazone, is flooding the Type 2 diabetes treatment market all over the world.
There are several side effects associated with Actos. You should seek medical attention if you experience:
- shortness of breath or trouble breathing,
- chest pain,
- extreme fatigue,
- irregular heartbeat,
- dilated neck veins,
- swelling of face, fingers, feet, or lower legs,
- decreased urine output, and
- weight gain
Although Actos is not illegal in the United States, the FDA said in 2012 that the brand-name drug must have the strongest possible warning label on the box, so that patients understand that they are at risk of developing serious complications. Other countries, such as France and Germany, banned use of the drug after several studies linked Actos to bladder cancer after taking the drug for only 2 years.
The Strom Law Firm Can Help with Personal Injury and Wrongful Death Cases, Including Against Actos
If you or a loved one have taken Actos to treat Type 2 diabetes, and have since suffered dangerous side effects including developing bladder cancer, heart disease, liver failure, or diabetic macular edema, you may be entitled to compensation. The attorneys at the Strom Law Firm can help with personal injury cases, including against Actos manufacturer Takeda Pharmaceuticals. We offer free, confidential consultations to discuss the facts of your case, so do not hesitate to contact us. 803.252.4800