Drug treatment took center stage at the 29th Annual SoCal Alzheimer’s Disease Research Conference late last month at the Irvine Marriott hotel.
The event was hosted by UCI MIND, or the institute for memory impairments and neurological disorders—one of 30 Alzheimer’s research centers funded by the federal government—and Alzheimer’s OC.
There is no cure for Alzheimer’s disease, which destroys memory and other cognitive abilities.
The good news, according to conference participants, is that the Food and Drug Administration has approved five drugs that are designed to treat the diseases’ symptoms.
Dr. Constantine Lyketsos, a professor at Johns Hopkins University School of Medicine, said at the conference that a number of treatments are showing potential to enhance patients’ quality of life but noted there’s no “one-size-fits-all cure.”
Lyketsos specializes in research focused on the treatment of neuropsychiatric features, particularly agitation, of patients with Alzheimer’s and related dementia.
Drug developer Accera Inc. in Denver, Colo., which once promoted antiamyloid drugs as “a new hope” in Alzheimer’s disease, announced disappointing third-phase study results last year. Amyloid is a protein normally found throughout the body. When it divides incorrectly, it forms a plaque-like buildup outside nerve cells, one of two brain abnormalities that define Alzheimer’s disease.
Lyketsos said the drug hasn’t shown much promise for those with advanced dementia. However, he noted that new studies are investigating whether it might be effective if administered to patients who haven’t shown symptoms but may carry genes that could lead to Alzheimer’s or have some damage to the hippocampus, the part of the brain associated mainly with long-term memory.
Meanwhile, OC’s Avanir Pharmaceuticals Inc. in Aliso Viejo develops drugs that treat disorders of the central nervous system. Its research and development pipeline includes a drug that treats agitation in Alzheimer’s patients.
The company, a wholly-owned subsidiary of Japanese firm Otuska Pharmaceutical Co. Ltd., already has two FDA-approved drugs.
One is Nuedexta, which treats pseudobulbar affect, a neurologic condition that can result in sudden and involuntary episodes of crying and/or laughing that are exaggerated or do not match what the person is feeling inside. Conditions that can lead to pseudobulbar affect include Alzheimer’s disease, as well as other injuries, such as stroke and traumatic brain injury.
UCI MIND Director Dr. Joshua Grill said there’s no lack of promising treatments but that the field needs more research participants, especially for clinical trials.
The center is recruiting people 50 and older who’ve been diagnosed with mild cognitive impairment or mild dementia due to Alzheimer’s.
The planned 12-month study will investigate whether a high daily dose of nicotinamide, a component of vitamin B3, can affect a brain marker associated with the disease.
It’s also calling for 300 adults 65 to 89 to participate in a study to identify the ideal amount of exercise for their age group. Study participants receive a membership to a local YMCA and will work out four times a week, twice a week with a personal trainer, and twice a week on their own, for a year.
Accera’s disappointing drug offering results aren’t the only recent setback in the sector.
This year, New York-based Pfizer Inc. (NYSE: PFE), Indianapolis-based Eli Lilly and Co. (NYSE: LLY), and Kenilworth, N.J.-based Merck & Co. (NYSE: MRK) announced the failure of their late-stage Alzheimer’s drug candidates.
Aivita Trial
Irvine-based Aivita Biomedical started treatment on the first of 10 people enrolled in its second-phase trial of advanced ovarian cancer patients.
The biotech firm plans to eventually enroll 99 patients for the randomized trial. Ovarian cancer is the fifth most common cause of female cancer deaths. There have been an estimated 22,240 diagnoses this year and 14,070 deaths, according to the privately held company.
Aivita also has an ongoing second-phase clinical trial in the U.S. treating glioblastoma. The aggressive cancer can occur in the brain or spine.
The company uses the patient’s tumor cells to create a personalized therapy designed to engage his or her immune system to fight cancer. The treatment was previously tested in two second-phase trials in patients with advanced skin cancer and approved for third-phase testing.
Aivita plans to commercialize the skin cancer treatment in Japan, and is “considering Japanese strategic partners for this program,” it said in a statement.
