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Another reason why I hate the GOP - government haults sucessful pd drug

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DanCa Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Sep-08-05 10:37 PM
Original message
Another reason why I hate the GOP - government haults sucessful pd drug

September 8, 2005

Dear Friends and Community Members:

On Sunday, September 11, the CBS television newsmagazine 60 Minutes is scheduled to air a program on the controversy surrounding recent clinical trials of GDNF, a growth factor that is widely believed to have potential for the treatment of Parkinson’s disease. This is a media event of great importance to the Parkinson’s community and we strongly encourage you to watch it. Check your local listing for air times. Although none of us have seen the segment, we do expect it to feature representatives of the key players in the issue, including the patients who participated in the trial and the doctors who treated them. It will also surely direct a public spotlight on the complex process of drug development, including the rights and roles of manufacturers, regulators and of course the trial participants (and their families) on whom the entire process of clinical trials depends.

At the Parkinson’s Disease Foundation and the Parkinson’s Action Network, we have taken the position that the GDNF trial participants who, with physician concurrence, wish to have their access to GDNF reinstated, should be permitted to do so. Amgen’s decision to refuse patients and their doctors was a mistake because it denies them the opportunity to continue with a potentially useful treatment, and it denies us all the opportunity to gather more scientific data about the long-term effects of GDNF. Similarly, PDF and PAN have consistently called on Amgen to provide more information to the PD community about the future of GDNF research. We believe that this was not done in the Amgen-GDNF case and have accordingly been critical of the company and the role it has played.You should also be aware that a group of Parkinson’s community leaders are using the 60 Minutes story to build support for a national drive to raise awareness of the issue and generate support both for the GDNF trial participants and for a commitment to serious future research on the potential of GDNF and other growth factors to help people with Parkinson’s. They have organized a network of leaders in dozens of communities and have prepared useful materials for use by local activists, speakers and people who want to write letters to the editors of their local newspapers. If you would like more information on this community effort, contact .------

We encourage you to watch this important television program. If you have any reaction you would like to share afterwards, please contact either of us at .

Best regards.

Sincerely yours,


P.S. Bear in mind that television schedules can change, especially when breaking news is involved. Be sure to check your local TV listing a day or two ahead of time to make sure that the segment is indeed airing on September 11.

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blue neen Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Sep-08-05 10:49 PM
Response to Original message
1. I'll definitely have to watch this.
My mom has early onset Parkinson's. She had to go off of Requip because she was having horrible side effects. The doctor put her on L-Dopa, which is helping. I understand though, that it only works for a limited amount of time.

Where can I get more info about GDNF?
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DanCa Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Sep-08-05 10:57 PM
Response to Reply #1
2. Here is all the info you need
Edited on Thu Sep-08-05 10:59 PM by DanCa
FROM: BusinessWire

July 18, 2005 07:00 AM US Eastern Timezone
BrainStorm Cell Therapeutics Announces Adult Stem Cell Breakthrough
for Neurodegenerative Diseases; Differentiation into GDNF-Producing
Astrocytes

NEW YORK & TEL AVIV, Israel--(BUSINESS WIRE)--July 18, 2005--
BrainStorm Cell Therapeutics (OTCBB:BCLI), today announced a
breakthrough in the development of adult stem cell therapeutics for
neurodegenerative diseases. The company's scientific collaborators at
Tel Aviv University, have successfully used adult stem cells to
produce glial derived neurotrophic factor (GDNF). GDNF producing
cells hold great promise for treatment of Parkinson's and other
neurodegenerative diseases.In the current study, the research team at Tel Aviv University usedproprietary technology, to differentiate human bone-marrow-derivedmesenchymal-stem cells into neural supporting cells that produceGDNF. Worldwide rights to these research results are exclusivelylicensed to BrainStorm.GDNF has been shown to protect dopaminergic brain cells, neurons thatproduce dopamine that becomes depleted in Parkinson's patients. GDNF has also been shown to have a beneficial role in protecting neurons in animal models of Amyotrophic Lateral Sclerosis (ALS) and SpinalCord Injury (SCI).
Most of the current treatment of neurodegenerative diseases provide
limited benefit to patients. Drugs for Parkinson's disease, which
focus on dopamine supplementation, often cause prohibitive side
effects. To overcome these problems, researchers around the world are
intensively exploring novel cell- and gene-based therapies for
replacement and augmentation of the lost neurons. Prominent among
these novel therapies are attempts to deliver GDNF to the site of
neuronal regeneration. In the current BrainStorm-sponsored study at Tel Aviv University, biochemical and immunological methodology showed that human bone marrow mesenchymal stem cells may be uniquely differentiated into cells that resemble astrocytes, express astrocytic markers and
produce significant levels of GDNF.The same scientific team at Tel Aviv University, led by ProfessorEldad Melamed and Dr. Daniel Offen, have previously developed patent-pending technology to differentiate human bone marrow into dopamineproducing neuron-like cells, which showed functional benefit in animal models of Parkinson's disease. This technology is alsoexclusively licensed to BrainStorm.

"Neurologists have long thought that GDNF can be used to preserve and
maintain the integrity of dopaminergic neurons in Parkinson's
disease. However, delivery to the appropriate location is a major
challenge. Direct delivery of the protein has failed and there are
current ongoing attempts at gene therapy. We believe that our
approach, based on neural transplantation of stem cell derived GDNF
producing cells, without any genetic manipulation, is preferable,"
said Prof. Eldad Melamed, Chairman of the Scientific Advisory Board.
In addition, "The use of a patient's own bone marrow stem cells to
generate neural cells for replacement and support of a patient's
damaged dopaminergic cells is a strategy that will avoid problems of
immunological rejection," said Dr. Daniel Offen, Chief Scientist.

"This is a remarkable achievement which combined with our previous
success in producing dopaminergic cells, gives us a two-pronged,
synergistic approach to develop long term alternatives for the
treatment of Parkinson's disease and other debilitating disorders,
such as ALS or SPI," said Yaffa Beck, President and CEO. " We look
forward to demonstrating benefit of the GDNF producing cells in
animal models and are intent on developing both our dopaminergic and
GDNF differentiation processes to the clinic," she added. About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is an emerging company developing neural-like stem cell therapeutic products, NurOwn(TM), based on autologous bone marrow derived stromal cells, for treatment of neurodegenerative diseases. NurOwn(TM) patent pending technology is based on discoveries made by the team of prominent neurologist, Prof. Eldad Melamed, Head of Neurology at Rabin Medical Center, and expert cell biologist Dr. Daniel Offen, at the Felsenstein Medical Research Center of Tel-Aviv University, enabling the differentiation of bone marrow derived stem cells into functional neurons, as demonstrated in animal models. The company holds rights to develop and commercialize the technology through an exclusive, worldwide licensing agreement with Ramot at Tel Aviv University Ltd., the technology transfer company of Tel Aviv University. The company's initial focus is on developing treatments for Parkinson's Disease.

About Stem Cell Therapy
Stem cells are non-specialized cells with a remarkable potential for
both self-renewal and differentiation into cell types with a
specialized function, such as muscle, blood or brain cells. Stem
cells may be sourced from fetal or embryonic tissue or from adult
tissue reservoirs such as bone marrow. Use of embryonic stem cells,
has become the center of significant ethical and moral debate. In
contrast, use of adult stem cells does not face the same moral or
legal controversy. Stem cell therapy aims to "cure" disease by
replacing the 'diseased' cells with 'healthy' cells derived from stem
cells. This approach has the potential to revolutionize medicine and,
if successful, the implied commercial opportunities are great.
Currently, both embryonic stem cells (ESC) and adult stem cells (ASC)
are being explored as the potential basis for multiple cell therapy
products.

About Parkinson's Disease Parkinson's Disease (PD), which was first described by James Parkinson in 1817 as "the shaking palsy", is a chronic, progressiveneurodegenerative disorder, affecting the brain cells responsible for production of dopamine. The symptoms include tremors, rigidity, slowness of movement and impaired balance. Over four million people in the developed world, including as many as 1.5 million Americans, mainly over the age of 65, are diagnosed with PD. That figure is predicted to rise by 10% by 2010. Pharmaceutical treatments of PD with an estimated combined annual market value of $4 billion, are insufficient to meet patient needs. The search for more effectivetreatments continues. Safe Harbor Statement Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risksand uncertainties that could cause BrainStorm Cell Therapeutics Inc.actual results to differ materially from those stated or implied by such forward-looking statements. The potential risks and
uncertainties include, among others, risks associated with BrainStorm
Cell Therapeutics Inc. limited operating history, history of losses
and expectation to incur losses for the foreseeable future; need to
raise additional capital to execute on its business plan; dependence
on its license to Ramot's technology and ability to meet its funding
and payment obligations included in such license agreement; ability,
together with its licensor, to adequately protect the NurOwn(TM)
technology; dependence on key executives who have recently joined the
company and on its scientific consultants; ability to identify,
negotiate and successfully implement strategic par!
tnering relationships; ability to complete clinical trials
successfully and to obtain required regulatory approvals; competition
with companies, some of which have greater resources and experience
in developing and obtaining regulatory approval for treatments in
BrainStorm Cell Therapeutics Inc. market; the limited public trading
market for BrainStorm Cell Therapeutics Inc. stock which may never
develop into an active market; and other factors detailed in
BrainStorm Cell Therapeutics Inc. annual report on From 10-KSB,
quarterly reports on Form 10-QSB, current reports on From 8-K and
other filings with the Securities and Exchange Commission available
at http://www.sec.gov/ or by request to the Company.
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blue neen Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Sep-08-05 11:19 PM
Response to Reply #2
5. Thanks for all of the information.
This is new territory for our family. I am trying to educate myself as much as possible.

Thanks again. :yourock:
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DanCa Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Sep-09-05 08:57 AM
Response to Reply #5
6. Here is some organizations you might try.
www.yopa.org
www.plwp.org
www.northeastparkinsons.com
Midwest Parkinson's Assoociation.
PM and Ill give you the directors contact info and introduce you to everyone in chat.
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charlie Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Sep-08-05 11:06 PM
Response to Original message
3. Geez, I'm sorry Danny
Culture of Life Death Merchants... they're beyond despicable. Goddamn, I HATE them.
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DanCa Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Sep-08-05 11:15 PM
Response to Reply #3
4. Not only that but I think it's the pharmicies too.
My drugs alone is probably payin for someone's boat.
I just feel sorry for the people that you'll see in the story.
How can anyone call themselves a christian and deny someone treatment that was working is beyond me.
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