Replies to post #313654 on Elite Pharmaceuticals Inc (ELTP)

[dest_golf]

Sorry but don’t believe the the disinformation about a tentative agenda, final conference brochere does not list or reference trail being presented.. Eventually all will come around and the focus will shift to something else

[Just give me $1.50]

If isradipine shows it has a clinically meaningful benefit as a disease modifying agent in subjects with early parkinson disease, sales will be through the ROOF.

There are currently only two manufacturers of isradipine. One of the two is Elite.

Keep your eyes peeled for May 7 at 11:00 am.

If this drugs shows efficacy, how much revenue is ELTP anticipated to make from its sale?

[NASDAQ2020]

Isradipine Parkinson’s 3 year $23 million dollar Study completed Nov 2018
Results Imminent

Quote:
STEADY-PD III (isradipine) clinical trial results will be released at the 2019 American Academy of Neurology meeting in Philadephia on the 4th-10th May, 2019.

http://tools.aan.com/annualmeeting/search/index.cfm?fuseaction=home.detail&id=7296&keyword=&topic=&type=all


https://scienceofparkinsons.com/2019/02/28/february-2019/#more-52900

There are +1,000,000 Parkinson’s patients and another 1,000,000 hypertensives with a family history of PD
TWO
Pharmaceuticals to supply:
Watson and Elite .

$500per year per patient
Split $1 Billion between Watson Elite and the Pharmacies
Watch what happens to the SP

Watch for leaks


—————————————————————————

Scientists believe isradipine works to prevent the death of dopamine-producing cells and therefore may slow the progression of PD.

Isradipine can affect the function of specialized channels that are present in the types of brain cells that are affected in PD patient. These cells are usually responsible for making dopamine, which is depleted in patients with PD. Isradipine may block the damage caused by the flow of certain chemicals through these channels. Laboratory data has showed that Isradipine may prevent the development of Parkinson-like symptoms in animals.

5 mg of isradipine taken twice daily for 36 months.

https://clinicaltrials.gov/ct2/show/NCT02168842

STEADY-PD III $23 million Isradipine/Parkinson’s PHIII clinical trial results will be released at the 2019 American Academy of Neurology meeting in Philadephia 11:00 am EST May 7, 2019.

https://scienceofparkinsons.com/2019/02/28/february-2019/#more-52900


The $#!+hole in closin in !

Parkinson's Disease ‘ may’ start being treated off label on May 7th with Elite’s blood pressure drug Isradipine.

https://www.medicalnewstoday.com/articles/322312.

Quote:
STEADY-PD III (isradipine) clinical trial results will be released at the 2019 American Academy of Neurology meeting in Philadephia on the May 7th 2019 at 11:00am

https://scienceofparkinsons.com/2019/02/28/february-2019/#more-52900

an antihypertensive drug, is emerging as a potential new treatment for Parkinson's disease due to promising results of in vitro tests. Until now, it was unclear whether administering the drug in vivo would yield the same benefits — new research shows that it does.

Isradipine is a calcium-channel inhibitor used to treat hypertension.

If human trials are successful, we could have the first drug that slows down the progression of Parkinson's disease.

Previous studies have found that people who took Elite’s Isradapine had lower rates of Parkinson's disease, so scientists wanted to examine it closely.

Further tests showed that Isradapine protects the dopamine-producing neurons that are affected in Parkinson's disease.

Now, a new study shows that treating mice with the drug protects the rodents' dopaminergic neurons as well.

D. James Surmeier, Ph.D., who is the Nathan Smith Davis Professor of Physiology at Northwestern Medicine in Chicago, IL, led the study, and the findings were published in the Journal of Clinical Investigation.

Isradipine affects the neurons' mitochondria

Prof. Surmeier and team administered isradipine to mice for 7–10 days. Then, using a quantitative imaging technique called two-photon laser scanning microscopy, they measured the levels of calcium inside the dopamine-producing neurons.

The tests found that the drug had lowered calcium levels inside these cells. This is important since calcium channels stimulate the mitochondria of dopaminergic neurons, sometimes making these brain cells overly active.

Prof. Surmeier says that this occurs due to the evolutionary role of dopaminergic neurons. These cells are key for activating brain regions responsible for quick motor responses, which is very useful in "fight-or-flight" situations, such as being confronted by a predator.

However, to fulfill this high-energy role, these neurons need to keep their mitochondria working at full capacity at all times. Mitochondria are tiny organelles inside of cells that are responsible for turning fats and nutrients into energy, or the cells' fuel.

Working to such a high capacity at all times is not only no longer necessary in our society, but it can create toxic byproducts. Such toxic compounds ultimately kill neurons, which is what happens in Parkinson's disease.

But in this study, isradipine inhibited calcium channels, which slowed the activity of mitochondria and lowered the production of toxic compounds.

Also, after treatment with isradipine, the mitochondria of the dopamine-producing neurons had a lower level of oxidative stress than untreated cells.

The scientists also found that high oxidative stress in dopaminergic neurons damaged the cells' mitochondria.

However, treating mice with isradipine lowered this mitochondrial damage. "We diminished the damage being done to mitochondria enough that dopaminergic neurons looked the same as neurons that are not lost in Parkinson's disease," says Prof. Surmeier.

Last but not least, the drug did not induce any side effects, and the rodents continued to behave normally.

The researchers say that the findings reinforce the efforts of a nationwide clinical trial that is now testing isradipine in humans.

The trial, called STEADY-PD, finished its third phase, at Northwestern Medicine and 50 other sites in the United States.

Dr. Tanya Simuni, who is the chief of movement disorders in the Ken & Ruth Davee Department of Neurology at Northwestern University, is the primary investigator of this trial. She is hopeful about the results of this study in rodents.

"These data provide additional strong preclinical rationale for the ongoing phase III study of isradipine in human patients [...] We are cautious as so many drugs have failed, but if successful, isradipine will be the first drug to demonstrate the ability to slow progression of Parkinson's disease." -- Dr. Tanya Simuni

$23 + million from NIH just to fund the isradipine Phase 3. Millions more from NIH and MJFF for pre-clinicals and Phase 2. Massive public spending on behalf of PD patients and to the benefit of Elite shareholders. Close to half the market cap of the company spent but not a dime from ELTP treasury.

Elite has only ONE puny competitor for Isradipine.

https://clinicaltrials.gov/ct2/show/NCT02168842?term=isradipine


Elite’s Isradipine is a calcium channel blocker approved for the treatment of high blood pressure and was recently tested as a disease-modifying drug for Parkinson’s Disease.
There is solid scientific basis as well as preclinical and epidemiological data that isradipine has the potential to prevent development of parkinsonian signs.
Positive results from a Phase II study have provided support for a Phase III trial, STEADY-PD III, a major step toward a novel treatment to slow the progression of PD.
A lack of healthy dopamine neurons in the brain is the major cause of the motor symptoms of Parkinson disease (PD).

Dopaminergic nerve cells are unique in the brain because they have their own pacemaking rhythms.
These special rhythm changes are being driven by the chemical channels that are either sodium or calcium.
Calcium is more energy demanding and with age, these neurons increasingly rely on calcium channels.
What is the science behind it? The neuron cells’ reliance on calcium to drive this activity creates a lot of ‘wear and tear’ on dopamine neurons-aging them more rapidly than other neurons and making them vulnerable.

Calcium channel blockers (class of drugs frequently used to treat high blood pressure), have possible neuroprotective effects that can slow or stop Parkinson’s progression.
Population studies have shown that current long-term use of calcium channel blockers has been associated with a significantly reduced risk of Parkinson disease.

STEADY-PD III (isradipine) clinical trial results will be released at the 2019 American Academy of Neurology meeting in Philadephia on the 4th-10th May, 2019.

https://scienceofparkinsons.com/2019/02/28/february-2019/#more-52900


[img]http://steadypd3.files.wordpress.com/2014/05/steadypd-3-neuron.png[/img