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Pharma stock plunges after 4th and 5th patients die from clinical trial
Posted on 11/23/16 at 9:14 am
Posted on 11/23/16 at 9:14 am
quote:
Shares of Juno Therapeutics dropped 33 percent in early market trade after the biopharmaceutical company announced complications with its Phase II clinical trial of JCAR015.
In Wednesday premarket trade, Juno's stock price dropped as much as 44 percent, before recovering somewhat.
The trial was voluntarily placed on hold after two patients suffered cerebral edema earlier this week; both died, bringing the study's death toll to five.
The JCAR015 drug was designed to fight cancer by using patients' own immune systems against the disease. However, the drug prototype has been plagued by issues in testing.
Three additional patients died in July from side effects of studying the same drug.
Following the death of the patient this week, the company has contacted the Food & Drug Administration and is collaborating with the Data and Safety Monitoring Board to determine how to move forward.
Yikes.
6
Posted on 11/23/16 at 9:14 am to slackster
Well, it is called a trial.
Posted on 11/23/16 at 9:15 am to slackster
quote:
to determine how to move forward.
dont
Posted on 11/23/16 at 9:15 am to slackster
This is why we have trials
These patients had incurable disease, their deaths might save future lives
These patients had incurable disease, their deaths might save future lives
Posted on 11/23/16 at 9:16 am to Cosmo
quote:
This is why we have trials
These patients had incurable disease, their deaths might save future lives
THIS
Posted on 11/23/16 at 9:16 am to Yellerhammer5
quote:
Well, it is called a trial.
Sure, I understand the necessity of it. I wonder how many patients are in the trial and how deadly it can get before they blow it up.
Posted on 11/23/16 at 9:20 am to slackster
This was their release after the trial was halted in the summer when 3 patients died:
[img]SEATTLE--(BUSINESS WIRE)--Jul. 12, 2016-- Juno Therapeutics, Inc. (Nasdaq: JUNO), a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, today announced that the U.S. Food and Drug Administration has removed the clinical hold on the Phase II clinical trial of JCAR015 (known as the “ROCKET” trial) in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL).
Under the revised protocol, the ROCKET trial will continue enrollment using JCAR015 with cyclophosphamide pre-conditioning only.[/img]
[img]SEATTLE--(BUSINESS WIRE)--Jul. 12, 2016-- Juno Therapeutics, Inc. (Nasdaq: JUNO), a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, today announced that the U.S. Food and Drug Administration has removed the clinical hold on the Phase II clinical trial of JCAR015 (known as the “ROCKET” trial) in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL).
Under the revised protocol, the ROCKET trial will continue enrollment using JCAR015 with cyclophosphamide pre-conditioning only.[/img]
Posted on 11/23/16 at 9:21 am to slackster
Brave people giving of themselves to find a cure. That's love.
Posted on 11/23/16 at 9:22 am to slackster
quote:
Yikes
There is no Yikes to it. Side effect deaths in pharma are now and always will be common.
Posted on 11/23/16 at 9:23 am to Sao
If I have an incurable disease I will take any trial drugs they want me to.
Posted on 11/23/16 at 9:23 am to Sao
What a fuxking surprise, pharma drugs kill people 
This post was edited on 11/23/16 at 9:24 am
Posted on 11/23/16 at 9:24 am to CoachDon
quote:
Brave people giving of themselves to find a cure. That's love.
More likely that they're looking for any option to continue living
Posted on 11/23/16 at 9:25 am to nicholastiger
quote:
If I have an incurable disease I will take any trial drugs they want me to.
I'd probably try to become an X-Man by drinking plutonium or something
Posted on 11/23/16 at 9:27 am to Sao
quote:
There is no Yikes to it. Side effect deaths in pharma are now and always will be common.
What is common? How many deaths from side effects are the norm? This isn't some sort of gotcha question, I'm genuinely curious.
Posted on 11/23/16 at 9:33 am to slackster
I would have to look but it's prevelent. Now, some is of course noncompliance but others are catalysts for organ failure singularly and of course, contra-indication which is the result of what occurs when 2 or more RX are used together and have killing effects by one form or another. I guess I'm saying pharma kills a lot of people anyway... hate these folks died but like them, I would rather go out fighting, too.
Posted on 11/23/16 at 9:38 am to slackster
Trial & Error
Posted on 11/23/16 at 9:39 am to CoachDon
You are correct and sometimes it take decades for the value of their bravery to bare fruit. I work for a molecular diagnostic company and the archived tumor tissue from patients involved in the eighties led to our developing a test that determines if patients need chemo and has revoluntized how early stage breast is treated. Whenever we reach a mile stone the doctor who founded the company will say " let us take a moment to reflect on the brave woman who participated in these pivotal trials "
Posted on 11/23/16 at 9:44 am to slackster
quote:
Shares of Juno Therapeutics dropped 33 percent in early market trade after the biopharmaceutical company announced complications with its Phase II clinical trial of JCAR015.
In Wednesday premarket trade, Juno's stock price dropped as much as 44 percent, before recovering somewhat.
The trial was voluntarily placed on hold after two patients suffered cerebral edema earlier this week; both died, bringing the study's death toll to five.
Sounds like now is the time to buy.
Posted on 11/23/16 at 10:06 am to Cosmo
All of these patients had either relapsed or treatment-resistant leukemia, so I think that's the best way to look at these unfortunate incidents.
The strategy used in this study, taking the patient's own immune cells and engineering them to target and kill cancer cells, is probably the most promising idea in oncology in decades. Sadly, sometimes the immune cells are so effective and get so ramped up killing the cancer that the patient's body can't withstand it.
The strategy used in this study, taking the patient's own immune cells and engineering them to target and kill cancer cells, is probably the most promising idea in oncology in decades. Sadly, sometimes the immune cells are so effective and get so ramped up killing the cancer that the patient's body can't withstand it.
Posted on 11/23/16 at 10:11 am to STLDawg
quote:
The strategy used in this study, taking the patient's own immune cells and engineering them to target and kill cancer cells, is probably the most promising idea in oncology in decades. Sadly, sometimes the immune cells are so effective and get so ramped up killing the cancer that the patient's body can't withstand it.
Yup. Cerebral edema is a common deadly side effect with these types of treatments. Curious to see what their eligibility criteria were. A lot of new information is coming in and a lot is being learned about identifying and reducing these effects. They need to block IL6 as soon as certain symptoms are identified.
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