Genentech Alzheimer's drug misses goals in studies - KWES NewsWest 9 / Midland, Odessa, Big Spring, TX: newswest9.com |

Genentech Alzheimer's drug misses goals in studies

Posted: Updated:
  • NationalMore>>

  • Baby dies after being left in hot car in Kansas

    Baby dies after being left in hot car in Kansas

    Friday, July 25 2014 4:44 PM EDT2014-07-25 20:44:48 GMT
    Police have arrested the foster parent of a 10-month-old girl who died after being left inside a hot car in Wichita, Kansas.
    A 10-month-old Kansas girl died after being strapped for more than two hours inside a sweltering car, and police arrested a foster parent who said he'd forgotten about her until something on TV jogged his memory, an...
  • Carjacked vehicle hits crowd, killing 2 children

    Carjacked vehicle hits crowd, killing 2 children

    Friday, July 25 2014 4:10 PM EDT2014-07-25 20:10:32 GMT
    Two men forced a woman into the backseat of her vehicle at gunpoint, drove off but later lost control and plowed into a group of people on a corner near a fruit stand in Philadelphia on Friday, police said. Two...
    Two men forced a woman into the backseat of her sport utility vehicle at gunpoint, drove off but later lost control and plowed into a group of people on a corner near a fruit stand in Philadelphia on Friday, police said....
  • Fukushima study: Think about unthinkable disasters

    Fukushima study: Think about unthinkable disasters

    Friday, July 25 2014 3:56 PM EDT2014-07-25 19:56:06 GMT
    A U.S. science advisory report says a key lesson from Japan's Fukushima nuclear accident is that the nation's nuclear industry needs to focus more on the highly unlikely but super-serious worst case scenarios.
    A U.S. science advisory report says Japan's Fukushima nuclear accident offers a key lesson to the nation's nuclear industry: Focus more on the highly unlikely but worst case scenarios.
By MARILYNN MARCHIONE
AP Chief Medical Writer

An experimental drug from the biotech company Genentech failed to slow mental decline in mid-stage studies on more than 500 people with mild to moderate Alzheimer's disease, but showed some promise in the least-impaired participants who received a higher dose.

Pneumonia and deaths were more common among those receiving the drug, but researchers downplayed that. Study leader Dr. Jeffrey Cummings of the Cleveland Clinic said none of the deaths seemed due to the drug and pneumonia occurred at a rate to be expected in older people.

"We're very encouraged" by the hint of benefit for patients with milder dementia and will talk with regulators about next steps for the drug, crenezumab (cruh-NEZ-oo-mab), said a Genentech scientist, Dr. Carole Ho. The results fit with other evidence suggesting that treating earlier in the course of the disease is better, she said.

Results were revealed Wednesday at the Alzheimer's Association International Conference in Copenhagen.

They are the latest mixed bag on treatments aimed at clearing away the sticky amyloid plaques clogging Alzheimer's patients' brains. About 35 million people worldwide have Alzheimer's, the most common form of dementia. There is no cure and current treatments only temporarily ease symptoms.

Last year, an Eli Lilly & Co. medicine, solanezumab, that also sought to clear away amyloid missed main goals in two studies but combined results suggested it might help people with milder disease. It's in further study now. Before that, bapineuzumab, a similar drug being developed by Pfizer Inc. and Johnson & Johnson, showed promise in mid-stage testing but flopped in larger, more definitive trials.

The Genentech drug has been closely watched because it targets amyloid more broadly than the other drugs do, and the California-based company has a long track record of success with many biological medicines against cancer.

Mid-stage studies aim to give some idea of safety and whether the drug is effective enough to advance to larger, more definitive studies aimed at winning market approval.

In one study, 431 patients ages 50 to 80 with mild to moderate Alzheimer's were given crenezumab or dummy drug as shots every two weeks, or as a higher dose in infusions every four weeks for 17 months. No significant difference was seen among the groups on two widely used measures of thinking and functioning skills.

However, the 70 most mildly impaired participants who received the higher dose declined 35 percent less on the cognitive measure than the 33 mildly impaired people given dummy infusions. The difference was about 3.5 points on the roughly 70-point scale - "equivalent to six or nine months" of delay in decline, Cummings said.

This result isn't definitive, though, and can only be considered a signal worth exploring in future research because it didn't involve the whole group tested. And even in this mildly impaired group, the drug did not improve the second measure, ability to function in daily life.

In the second study, 73 people who showed amyloid plaques on brain imaging also were given crenezumab or dummy shots or infusions. The main outcome - levels of amyloid seen on brain imaging after treatment - will be presented at a medical conference in November. Results on cognitive function seem to mirror those in the larger study, Cummings said.

Five people given crenezumab died - one from sudden death, two from respiratory failure, one from pneumonia and one from worsening Alzheimer's.

"We believe that the safety profile is acceptable," because deaths do not seem related to the drug, Genentech's Ho said. "It is not a show stopper."

Genentech and its corporate parent, Switzerland-based Roche Holding AG, paid for the study and Cummings is a paid adviser to Genentech.

In a statement Wednesday, the Alzheimer's Association noted that crenezumab was being tested in another study aimed at preventing the disease, and said the new results give hope it will be more successful in that setting.

___

Online:

National Institute on Aging: http://www.nia.nih.gov/Alzheimers

Patient, family info: http://www.alzheimers.gov/

Alzheimer's Association: http://www.alz.org

___

Marilynn Marchione can be followed at http://twitter.com/MMarchioneAP

Copyright 2014 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

  • InternationalMore>>

  • Nigeria confirms first Ebola death

    Nigeria confirms first Ebola death

    Friday, July 25 2014 4:44 PM EDT2014-07-25 20:44:29 GMT
    Nigerian officials say a Liberian man died of Ebola in a Lagos hospital Friday after arriving in the country on Tuesday. It is the first case of Ebola to be confirmed in Nigeria since the current outbreak began in...
    West Africa's current Ebola outbreak has spread to a fourth country, after a Liberian man vomited, had diarrhea and a high fever on an airplane to Nigeria.
  • Migrants: Obama urges Latin leaders, GOP to help

    Migrants: Obama urges Latin leaders, GOP to help

    Friday, July 25 2014 4:43 PM EDT2014-07-25 20:43:58 GMT
    President Barack Obama is summoning Central American leaders to the White House to discuss the influx of young immigrants from their countries to the U.S., hoping to show presidential action even as Congress...
    Pressing for action on Friday, President Barack Obama urged Central American presidents and congressional Republicans at home to help ease the influx of minors and migrant families crossing the southwest border of the U.S.
  • Teams converge on remote site to probe plane crash

    Teams converge on remote site to probe plane crash

    Friday, July 25 2014 4:35 PM EDT2014-07-25 20:35:39 GMT
    French officials say that the wreckage of an Air Algeria plane which crashed with 116 people aboard has been found in Mali.
    Aviation experts, criminal investigators and soldiers began converging Friday on an isolated patch of restive Mali to search for clues that might explain why an Air Algerie jetliner fell from the sky in a storm and...