CNN’s Dr. Sanjay Gupta reports on a new stem cell clinical trial that is making history.
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Stem Cell Medical Breakthrough?
Experiment seeks blood test for breast cancer
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News
Experiment seeks blood test for breast cancer
Tue, Mar 09 14:08 PM EST
By Maggie Fox, Health and Science Editor
WASHINGTON (Reuters) – An experimental approach that looks for the DNA leaking out from dead and dying cells may provide a route to a blood test for breast cancer, U.S. researchers reported on Tuesday.
An initial study showed the test detected 70 percent of breast cancer cases, and correctly cleared 100 percent of women who did not have breast cancer, the team at Chronix Biomedical, a privately-owned company in San Jose, California, said.
The experimental test is not ready to develop into a product but provides a basis for further research, they wrote in the journal Molecular Cancer Research.
“It is based on finding the unique DNA fingerprints from dead and dying cells,” Chronix CEO Howard Urnovitz said in a telephone interview.
Technological advances in DNA sequencing made the test possible, Urnovitz said. His team sequenced the entire genomes of 26 breast cancer patients and of 67 apparently healthy women.
They were looking for extra DNA in the blood of the breast cancer patients that would come from cells dying because of the tumors.
“If a breast cell is injured, it will overexpress the genes that make it a breast cell,” Urnovitz said. In theory, if a patient has excess DNA from breast cells that are dying, there is something going on that is killing breast cells.
The search is not easy. “The entire genome can be found in the blood,” Urnovitz said. And billions of cells die every day in the human body.
But eventually the Chronix team found what they believe is tell-tale DNA from dying breast cells.
“This study supports the potential of an entirely new approach to identifying cancer at its earliest stages when therapies may be most effective,” Dr. William Mitchell of Vanderbilt University School of Medicine in Tennessee, who worked on the study, said in a statement.
SCREENING AND MONITORING
“Laboratory tests using this approach may have the potential both to screen large populations for cancer before symptoms appear and to monitor patients for the recurrence of cancer once treated,” Mitchell added.
Much more testing needs to be done, Urnovitz said. But so far the test seems to specifically home in on breast cells. Unpublished data shows, for instance, that the DNA signature is not found in men with prostate cancer.
The cost of genetic sequencing will have to come down more before the test would be practical, Urnovitz added.
His team used Roche AG’s 454 sequencer at a cost of thousands of dollars per person, but companies are working to speed up sequencing and get the costs down.
The tests might be used to screen women for breast cancer and to tailor treatments, Urnovitz said.
“Imagine we can come in and say ‘you have damage to the protein kinase gene that would preclude you from these 10 cancer drugs, but here are 20 others that should work’,” he said.
“You would be selecting drug treatment based on each person’s lesions. This would be a really good example of personalized medicine.”
Urnovitz also hopes such a test could monitor patients who have completed treatment for cancer. Instead of coming to a cancer center to undergo a PET scan to check for tumors that may have returned, patients could get a blood test at their convenience and have it sent in for analysis.
“You could have one blood test for everything that is going on,” he said.
(Editing by Paul Simao)
First U.S. stem cells transplanted into spinal cord
First U.S. stem cells transplanted into spinal cord
By Miriam Falco, CNN Medical News Managing Editor
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Stem cells like these were injected into the spine of an ALS patient.
STORY HIGHLIGHTS
- Fetal cells injected into spine of man with advanced ALS
- There is no cure for ALS, better known as Lou Gehrig’s disease
- At least 12 patients expected to participate in early research on stem cells and ALS
- These are neural stem cells, which have ability to turn into different types of nerve cells
ATLANTA, Georgia (CNN) — For the first time in the United States, stem cells have been directly injected into the spinal cord of a patient, researchers announced Thursday.
Doctors injected stem cells from 8-week-old fetal tissue into the spine of a man in his early 60s who has advanced ALS, or amyotrophic lateral sclerosis. It was part of a clinical trial designed to determine whether it is safe to inject stem cells into the spinal cord and whether the cells themselves are safe.
ALS is a fatal neurodegenerative disease that causes the deterioration of specific nerve cells in the brain and spinal cord called motor neurons, which control muscle movement. About 30,000 Americans have ALS at any given time, according to the ALS Association.
There is no cure for ALS, which is better known as Lou Gehrig’s disease, named after the New York Yankees’ first baseman and Hall of Famer who retired from baseball in the 1930s after being diagnosed with the disease.
As the illness progresses, patients lose their ability to walk, talk and breathe. Patients usually die within two to five years of diagnosis, according the ALS Association.
Neuralstem Inc., a Rockville, Maryland-based biotech company, received approval from the U.S. Food and Drug Administration to conduct the clinical trial in September. The company is fully funding the research and provides the stem cells that are being injected into the patients.
Neuralstem announced the start of the clinical trial in a news release Thursday.
Longtime ALS researcher and University of Michigan neurologist Dr. Eva Feldman is overseeing the first human clinical trial of a stem cell treatment in ALS patients.
“We are entering a new era of cell therapeutics for ALS, and in my opinion, it is an new era of hope for patients with ALS,” Feldman said.
At least 12 patients are expected to participate in this early research. They are to receive the stem cell transplants at Emory University in Atlanta, Georgia.
“This is the first study to see if the invasive injection into the spinal cord is safe for the patient,” said Lucie Bruijn, science director of the ALS Association.
This first patient in the clinical trial received several injections of stem cells into the lumbar region of the spinal cord, the area that controls leg function, because most ALS patients first lose muscle function in their legs, according to Karl Johe, Neuralstem’s chairman and chief scientific officer.
Bruijn says there have been a few other occasions outside the United States in which fetal stem cells have been injected into a patient, “but not necessarily using a very [rigorous] trial design.” She adds that there were also a couple of small studies in Italy that injected other types of stem cells into a few patients but that this is the first FDA-approved trial in the United States.
“Our biggest hope for stem cells is to significantly slow the progression the disease,” Bruijn said.
The ALS Association is not providing funding for this clinical trial, but it has supported the work of Dr. Nick Boulis, the Emory neurosurgeon who developed the surgical technique used to inject the stem cells.
Johe invented the technology that allows the company to manufacture billions of copies of stem cells that are taken from a single source of spinal cord cells: cells that were extracted from fetal tissue, which was donated to the company.
“The cells are human neural stem cells,” Johe said, acknowledging that the introduction of stem cells is a very invasive procedure.
“What we are attempting is a novel approach by directly injecting them into the middle of the spinal cord, which to our knowledge has never been done before,” Johe said.
Researchers plan to follow this and future patients participating in this trial for a long time to determine the safety of the procedure.
These particular stem cells — which came from the spinal cord of an 8-week-old fetus — are neural stem cells, which have the ability to turn into different types of nerve cells. These are not the same stem cells as the controversial human embryonic stem cells, which destroy the embryo when the stem cells are removed.
Johe says that once the safety of this type of transplant is determined, he and his colleagues hope to see whether this is a possible treatment for ALS.
“This is not a cure. We are not replacing those motor neurons [nerve cells which tell muscles to contract]. These stem cells don’t generate motor neurons. Instead they protect the still-functioning motor neurons,” Johe explained.
Bruijn says that injecting stem cells into the spinal cord — in the region where the motor neurons are located that affect ALS — is a breakthrough. But she cautions that this is only the first step in the first part of this clinical trial. It’s too early to draw any conclusions about the effectiveness of this treatment, especially since the trial has only just begun.
She notes that everyone involved with the study and other ALS patients have to wait and see what the results of the clinical trial will be.
The FDA granted the first approval for injecting human embryonic stem cells into humans to Menlo Park, California-based Geron Corporation in January 2009. Their trials were expected to start last summer but have yet to begin.
FDA green lights stem-cell clinical trial for Lou Gehrig’s disease
NATURE PUBLICATIONS
FDA green lights stem-cell clinical trial for Lou Gehrig’s disease
September 22, 2009
http://blogs.nature.com/news/thegreatbeyond/2009/09/fda_green_lights_stemcell_clin.html
Monya Baker
The Maryland company NeuralStem has the U.S. Food and Drug Administration’s permission to test its spinal cord stem cells in twelve patients with amyotrophic lateral sclerosis. The approval comes a month after the FDA placed Geron’s planned clinical trial on hold for a second time. NeuralStem’s trial had also previously been placed on hold by the FDA in February before receiving the go-ahead in September.
Though both trials involve placing cells into the spinal cord, NeuralStem’s product is made of cultured neural stem cells derived from a single 8-week fetus; Geron’s product, intended to treat spinal cord injury, is derived from embryonic stem cells that have been differentiated into precursors of neuron-support cells.
This anti-impotence pill is formulated with viagra samples no prescription including sildenafil citrate that is the proven parent chemical that works best in treating male impotence, Preparations like Asparagus racemosus, Curculigo orchioides, Dactylorhiza hatagirea, curculigo orchioides, and Chlorophytum borivilianum are frequently prescribed by doctors to act as stimulants and increase the flow of blood to the sexual organs of the body. For example, the free expression that canadian viagra pills comes with sex like gasping, laughing, singing, sighing and sometimes coughing may be avoided or suppressed. You can free viagra prescription try content personally enroll as many as 1-in-3 suffering at least occasional episodes of premature ejaculation. Durex Real Feel: Given an option, men would any day prefer cheap sildenafil no prescription having sex without a condom than with one because the latex material of condoms reduces the overall pleasure of sex. “This is certainly the first stem-cell approach for ALS,” says Lucie Bruijn, a scientist at the ALS Association, a patient group that also funds relevant research. Most other approaches for treating ALS are small molecule drugs, she says, and she’s not aware of other cell therapy or other invasive approaches entering human testing in the near future.
ALS has not funded NeuralStem’s work directly, Briujn says, but has advised the company and funded academic scientists who’ve been involved with the company.
NeuralStem’s chief scientific officer Karl Johe says tests of large animal models show that the transplanted cells exert a neuroprotective effect over motor neurons, but it’s not entirely clear how. Earlier this year, Neuralstem and collaborators published results in a rat model of ALS showing that transplanted cells could develop into interneurons that formed synapses with the rats’ motor neurons.
However, Johe emphasized that the upcoming trial will assess safety rather than efficacy. The first few patients selected for the procedure will be those who are no longer able to walk. Because the injected cells protect rather than replace motor neurons, these sicker patients are less likely to benefit from treatment, but they are less able to lose function if something goes wrong. Cells will be injected only on one side of the spinal cord in order to minimize the number of injections into the spinal cord. Only one patient will be injected each month, so that researchers can monitor for effects over a longer period. Eventually, Johe says, the goal is to be able to inject cells in both lower and upper regions of the spinal cord in healthier patients, and see if the injections can keep motor neurons healthy.
The trial is expected to take place at Emory University in Atlanta, Georgia. Though the FDA is allowing the trial to go forward, the university’s patient-safety board will also need to approve the trial before it can proceed. Johe declined to say when that would be but said discussions were well underway.
Other companies using neural cells include ReNeuron, which received permission from UK authorities this January to start clinical trials for stroke. Its cell product is made from genetically modified cultures of neural stem cells, also of fetal origin.
StemCells Inc is conducting trials in Batten’s disease, a neurodegenerative disease that strikes children, and recently received approval for a clinical trial for a similar disease. It also uses neural stem cells from material originally derived from fetuses and has recently published results showing that its cell product delayed some symptoms of the disease by about three weeks.
As with human embryonic stem cells, the patent situation for neural stem cells is contentious. In a pair of dueling press releases this May, NeuralStem and Stem Cells Inc both claimed key intellectual property on these cells.
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* Doctors Tame One Of Cancer’s Deadliest Forms
Doctors Tame One Of Cancer’s Deadliest Forms
by Richard Knox
Listen Now http://www.npr.org/templates/story/story.php?storyId=99970093
or download here http://planetcommunications.us/media/20090129_me_07.mp3
Documentary filmmaker Hardy Jones was diagnosed with multiple myeloma in his late 50s. New drugs have helped him keep the cancer at bay for more than five years.
Morning Edition, January 29, 2009 · The chances of surviving cancer have been increasing in recent years. One of the most dramatic success stories in cancer care involves a little-known cancer called multiple myeloma that had been among the deadliest types of the disease.
Myeloma is a painful bone marrow cancer that affects white blood cells that make antibodies. When these cells become malignant, they crowd out other bone marrow cells. That weakens bones so much that patients can break a bone just stepping off a curb.
Hardy Jones, a documentary filmmaker and recreational surfer, was diagnosed with multiple myeloma when he was almost 60. He knew something was wrong when he lost his usual energy.
“I just couldn’t get that stoked feeling, no matter what I did,” Jones says. “I was just always draggin’.” He could barely trudge up the hill from his favorite surfing beach, carrying his surfboard and wet suit.
His doctor ran some tests and mentioned that Jones might have cancer. While waiting for the results, Jones started reading up on possibilities. Some were scary.
“I vowed that I would go in there and no matter what the diagnosis was, I’d be cool,” Jones says. “And when the doctor said, ‘Well, it’s multiple myeloma,’ I said, ‘Oh, my God!’ I totally cracked. I wasn’t cool. But he said, ‘Stop it! Stop it! This is not a death sentence!’ ”
Not any more.
Fighting Myeloma With Drugs
Now there are easy-to-take drugs that can keep myeloma at bay for years.
“Everybody responds, and the majority have a very significant response,” says Dr. Ken Anderson of the Dana Farber Cancer Institute in Boston. “So it’s clearly a new day in myeloma.”
Anderson says the big breakthrough came a decade ago. Cancer research pioneer Dr. Judah Folkman of Harvard, who died last year, suggested that doctors try treating myeloma with thalidomide. The notorious drug caused an epidemic of birth defects when doctors prescribed it to prevent morning sickness in pregnant women 50 years ago.
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Successes like this touched off an explosion of drugs effective against myeloma, some related to thalidomide and others that work in a different way.
“The excitement here is that we have six new treatment options that we didn’t have only five years ago,” Anderson says. “And we have three additional treatment strategies that are in the last stages, so-called phase three clinical trials, that likely will create additional options.”
Having drugs to mix and match gives myeloma patients hope of remissions even after they relapse — something unusual in cancer treatment.
“It really offers for us the opportunity to treat patients even when their myeloma has come back not once, but perhaps even many times,” Anderson says.
Avoiding Bone Marrow Transplants
Doctors can’t yet cure myeloma, but they’re turning it into a disease that patients can live with for many years. The median survival rate has recently increased from about three years to seven or eight.
U.S. and French researchers are about to launch an international study to see if the new drugs are better than bone marrow transplants, which put patients through a grueling regimen of toxic chemotherapy. Officially, transplants are still the first-line treatment for myeloma, although many patients such as Jones are looking at transplants as a last resort.
“Now the question becomes relevant: Do you actually need a transplant?” Anderson says. “That question couldn’t even have been asked before.”
The picture isn’t all positive. Dr. Brian Durie of the International Myeloma Foundation says more patients are being diagnosed with the disease.
“In the United States, there are approximately 20,000 new patients diagnosed each year,” Durie says. “The incidence used to be 12,000 new cases a year. So it’s a significant upward trend.”
But Dr. Vincent Rajkumar of the Mayo Clinic says the increase in numbers is from aging of the population, not a real increase in the rate of myeloma.
There’s also debate about whether environmental toxins are causing myeloma.
“The commonest chemical that has been linked to myeloma is dioxin,” says Durie. That’s why some Vietnam veterans are thought to have gotten myeloma — from exposure to Agent Orange. The Department of Veterans Affairs has acknowledged the link.
But among the civilian population, the picture isn’t as clear. Some studies are emerging that civilians exposed to herbicides and pesticides do have a higher risk of myeloma. But it’s difficult to pin down people’s exposures to environmental toxins and relate those exposures to the incidence of a rare disease.
The bottom line is that experts say it’s too soon to conclude that environmental toxins are the cause.
Election to benefit some industries, harm others
Election to benefit some industries, harm others
By CHRISTOPHER S. RUGABER
November 3, 2008
AP Economics Writer
WASHINGTON (AP) — Battered by the financial meltdown, America’s business community is anxiously calculating how Tuesday’s presidential election will affect it.
Energy, pharmaceutical and telecommunications companies could face tax and other policy changes no matter who wins the White House. The outcome also could determine how well alternative energy developers, generic biotechnology companies, stem cell researchers and others fare.
Labor unions put major resources behind Democrat Barack Obama and could wind up a big winner if he takes the White House. Nuclear power and the coal industry would get a boost if Republican John McCain prevails. Obama promises to raise corporate tax rates and income taxes on families making over $250,000; McCain promises to cut corporate taxes and extend all of President Bush’s tax cuts.
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A look at how some could fare:
STEM CELL RESEARCH
Few sectors have more to gain on Election Day than the nation’s fledgling stem cell companies, which long have bemoaned the administration’s policy limiting federal money for embryonic stem cell research. Bush believes the research is immoral because the process of culling the stem cells kills the embryo.
Both Obama and McCain support federal spending on stem cell research and could move to overturn current restrictions. Industry executives say the policy change would shore up investor confidence in stem cell developers.
“It will relieve a lot of uncertainty among the investment community that we are going to become an outlaw industry,” said Richard Garr, chief executive of Neuralstem.
FDA Hearings on Stem-Cell Drugs
FDA Hearings on Stem-Cell Drugs
By ALICIA MUNDY
April 10, 2008; Page D3
The contentious debate over embryonic-stem-cell research is entering a new chapter as biotech companies press the Food and Drug Administration to approve clinical trials for the first generation of stem-cell-derived drugs.
The FDA has set two days of hearings starting Thursday to discuss how the agency may regulate embryonic stem-cell therapies. FDA officials say they expect the hearing will draw a crowd of biotech executives, investors and researchers, and representatives of patient-advocacy groups.
The biotech industry and investors want more certainty about the FDA’s guidelines for the complex approval process ahead, and assurance that the FDA isn’t averse to approving embryonic-stem-cell therapies for political reasons.
One company involved in the hearings, Geron Corp., of Menlo Park, Calif., is set to file what it says is the world’s first embryonic-stem-cell proposal with the FDA. If approved, the company could begin human testing of a therapy to repair acute spinal injury. The company expects to submit its proposal this summer.
During a conference call with investors this year, executives touted the upcoming FDA panel. “We are actually playing a very central role,” said Chief Executive Tom Okarma, adding that the FDA had invited Geron to give “a major presentation.”
A lot of it has to do with dig this buy canada levitra what they think about the treatment that they’re getting. It works to restore sexual desire by freeing up testosterone, thereby allowing you to have better sex drive and stamina sales online viagra levels. Because of to their compact measurement, it does not necessitate a wonderful deal of salt to respitecaresa.org online cialis have detrimental affects. 6. The cost of the medicine commander cialis is about $ 1.00 per pill. “The FDA is nervous. It’s under tremendous pressure. They can’t appear adversarial but they can’t seem to be rolling over for industry, either” said Richard Garr, CEO of Neuralstem Inc., which develops adult-stem-cell products. Mr. Garr said he is worried that if the hearings focus on unresolved safety problems in embryonic-stem-cell technology the FDA could decide to slow down the process of considering stem-cell therapies. “It’s my nightmare scenario,” he said.
The hearings could provide a stage for some companies to make a splash about new cell-based drugs in development or to prod the FDA on shifts in the way it judges safety standards for embryonic-stem-cell therapies. The FDA is reviewing other stem-cell-based technologies, but embryonic stem cells are prized because they can regenerate quickly and act like almost any other cell in the body.
“There is now enough of a critical mass to have this meeting,” said FDA spokeswoman Karen Riley.
Concerns remain that embryonic stem cells can trigger benign tumors called teratomas.
“There’s always an issue for the FDA with novel technologies” on how to evaluate safety, said Celia Witten, director of the agency’s office of cellular, tissue and gene therapy.
One of the most-critical problems the FDA must tackle is how to determine the length of time for a stem-cell trial in animals before proceeding to human testing, Dr. Witten said.
URL for this article:
http://online.wsj.com/article/SB120779366925203837.html
Aastrom’s Stem Cells Knit Hard-to-Heal Bone Breaks
Aastrom’s Stem Cells Knit Hard-to-Heal Bone Breaks (Update1)
By Rob Waters
Oct. 18 (Bloomberg) — Aastrom Biosciences Inc. said its stem cell treatment repaired fractures in 91 percent of patients with previously hard-to-heal breaks in the long bones of their thighs, shins or arms.
The study tested stem cells developed by Aastrom by inserting them during surgery into the fracture sites of 33 patients with severe bone breaks that had previously failed to join from standard treatments. A year later, the fractures of 30 of the patients had healed, the Ann Arbor, Michigan-based company reported today at a medical meeting in Boston.
“We are treating patients that have not healed in the past and are unlikely to heal in the future with normal procedures,” said Elmar Burchardt, the company’s vice president of medical affairs, in a telephone interview. “It’s a completely new approach for bone treatment and tissue regeneration with the idea of restoring its original architecture.”
Aastrom, one of several U.S. companies working to bring stem cell-based treatments to market, has created a technique for expanding and purifying patients’ own stem cells as a therapy. The company is testing its approach in several orthopedic uses as well as in a disease that restricts blood circulation in limbs. It’s also developing treatments for patients with heart disease and spinal cord injuries.
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The company is furthest along in testing its cells to treat a rare condition called osteonecrosis that damages bone in the hips and other places because of a poor blood supply. The company is now recruiting 120 osteonecrosis patients for the final stage of testing normally required for regulatory approval. It could seek clearance from the U.S. Food and drug Administration as early as 2010, Burchardt said.
Aastrom rose 4 cents to $1.20 at 6:02 p.m. New York time in extended trading. The stock gained 2 cents to $1.16 at 4:20 p.m. in regular Nasdaq Stock Market composite trading.
The 30 bone-fracture patients who were deemed by the company to have healed all had bone scans that showed “multiple contact points” between pieces of bone that were formerly fragmented, Burchardt said. The patients’ limbs now “are fully weight- bearing and have full range of motion,” he said.
To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net .
Stem Cell Firms Struggle for Financing
Sep 1 2007 (Vol. 27, No. 15)
Stem Cell Firms Struggle for Financing
Lack of Proper Information, Over-regulation, and Confusion over IP Incites VC Hesitance
Gail Dutton
Venture capitalists say that they are very interested in stem cells but not enough to start funding stem cell companies. Right now, the business case for investment isn’t there. “Great science doesn’t equal great business,” points out Gregory A. Bonfiglio, managing director at Proteus Venture Partners.
Financiers, just past the stinging losses of the dot-com heyday, need a stronger business case nowadays for investments. In fact, it’s not just stem cell companies that are suffering. Venture capital in general is down from more than $100 billion in 2000 to less than $20 billion in 2006, Bonfiglio points out. Investments in all forms of regenerative medicine accounted for about $190 million, or less than 2% of total healthcare funding in 2005.
“VC’s goals beyond a minimum fivefold return are to get a company through two rounds of financing and generate human proof of concept—generally Phase IIA data—or build a broad platform with a strong intellectual property position that could create a lot of pipeline opportunities,” according to Doug Fambrough, Ph.D., partner, Oxford Bioscience Partners.
“I don’t think that exists in the stem cell world,” he says. “People don’t see the broad intellectual property protection that gives companies the freedom to operate and the ability to exclude. Therefore, I wouldn’t invest in a platform but in therapeutic opportunities.”
Stem cell based drugs, Dr. Fambrough adds, must have large potential markets, significant benefits compared to competitors, and the ability to be commercially supplied. A company needs to have its core research completed with proof of concept as well as a strong management team and a sturdy intellectual property position, Bonfiglio continues. Because so many of these ingredients are not yet apparent, Dr. Fambrough says he’s only interested in providing second-round financing.
Literature of Disinformation
There’s a certain bitterness expressed by stem cell company execs toward venture capitalists. The perception is that venture capitalists are risk averse, more so than even microcaps, institutional investors, or hedge funds, according to Richard Garr, J.D., CEO of Neuralstem (www.neuralstem.com). Another exec even went as far as to say that venture capitalists were “brain dead” for not embracing a technology that has the potential to become more important than recombinant therapy.
“Venture capitalists don’t understand the science at all, and they can’t go to their usual suspects for guidance, because they either are aligned with somebody’s technology,” Garr comments, or they are too far removed from the field to comment intelligently. “The private sector, in many areas, is way ahead of the academic sector in the stem cell world.”
Research has been conducted on embryonic stem cells for slightly more than a decade but has been sharply limited in many nations. “A lot more is known about adult stem cells,” Bonfiglio says, as they have been the object of research for the past 40 or more years. “But, they are limited in scope. Embryonic stem cells address any disease in the body. The problem is finding and isolating them.”
Tom Okarma, president and CEO of Geron (www.geron.com), points to the “literature of disinformation.” Some researchers, “are furious about the fact that original stem cell lines are officially fundable and they are not getting funded,” he elaborates. Others criticize the quality of the original lines, muddling the issue for scientists and financiers alike.
According to Okarma, research papers suggest that the original stem cell lines approved for NIH research by President Bush in 2001 were contaminated and thus unfit for clinical trials. Yet, Geron is using two of those original lines successfully. The difference, he says, is that Geron treated the cells under GMP conditions. “The scientific community generally doesn’t understand that. Most academics have no experience producing or qualifying cells for human therapy.”
There’s another fallacy, too. A big question is whether human embryonic stem cells are scalable. Dr. Fambrough thinks not, presenting a repugnant specter of harvesting cells from fetal cadavers. Geron’s Okarma bristles at the notion, dismissing it as a gross inaccuracy. “We’ve done hundreds and hundreds of population-doubling procedures for some of our lines without any changes in the cells. Our lines are 100 percent scalable, are Bush-approved, and two of them are fully qualified for human use.”
No Consensus on IP Status
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Impact of U.S. Regulation
The myriad of conflicts within the field is the direct result of the 2001 restriction on stem cell lines approved for federally funded research in the U.S., according to Okarma. “We need more science,” Okarma insists. “The field is in a state of confusion.” Since 2001, he says, the NIH has invested $2.8 billion in adult stem cell research and only $130 million on embryonic stem cell work. Consequently, individual companies have done the heavy lifting.
Firms are thus focusing on adult stem cells, effectively lessening the body of knowledge on their embryonic counterparts and the stem cell field in general. The latter will result in longer approval processes as lead candidates approach the FDA and other regulatory bodies in preparation for clinical trials.
To replace those peer-reviewed studies, companies will have to perform additional large investigations themselves. For example, big Phase III evaluations will be needed to correlate surrogate endpoints with clinical improvement. Such trials are on a scale that only big pharma can bear, if they are willing to buy in, Dr. Fambrough says. So, to attract venture capital, a lot of elements need to come together, including a clinical development path a small company can handle, he adds.
“The key to attracting funding is to be close to the clinic with a good IP position,” Garr emphasizes, “and it would be very difficult now to come up with something close to the clinic that is not already in one of the existing companys’ areas.”
Those who believe you have to make individualized therapies for each patient won’t get funded because that approach isn’t scalable, Okarma emphasizes. Yet, Tengion (www.tengion.com), a tissue engineering company founded in 2003, raised $50 million in a Series B financing in June 2006 for a total of $112 million. It began Phase II trials for a bladder construct last January using a patient’s progenitor cells that aren’t yet fully differentiated.
Financial Options
The financing plan for Neuralstem, according to Garr, has been very simple. “Avoid the VCs.” Founded in 1996, it has relied on private placements and grant work to advance its work in fetal-derived stem cells. Currently, Neuralstem is in the process of migrating from the OTC Bulletin Board to the American Stock Exchange and expects to begin its first human trial in 2008.
Garr says there’s an elitist attitude among VC firms. “If you are not hooked up with Harvard or Stanford, they don’t take you seriously.” That’s true for the NIH, too, Bonfiglio adds. “The NIH is focused more on stature within the academic community. DARPA, however, is more interested in the technology.”
Funding prospects may improve, although it will take some time. The prevailing sentiment is that the next U.S. presidential administration will lift the ban on stem cell research. “The political drive seems to be there,” Dr. Fambrough says. Garr predicts that the U.S. Senate has enough votes to overturn the ban, but the U.S. House of Representatives will hold firm. Yet, he says, “It’s a question of when, not if.” He also says that there is the strong possibility that a bill overturning the ban will be attached this year to must-sign legislation, like the Department of Health and Human Services funding bill.
Exit Strategies
As firms enter Phase II trials, they are beginning to consider their next financial moves. Traditionally, when Phase II is completed, venture capitalists are ready to exit. As one strategy, Bonfiglio mentions mergers as a potentially attractive option, as they provide cash upfront and stock in a liquid company. “Average merger and acquisition returns are now 2.5 times higher than IPOs. Other options include a reverse merger with a public shell company or a private investment in a public entity.”
Listing the stock on the London Stock Exchanges’ Alternative Investment Market (AIM) is another opportunity, he says. Admission to AIM takes three to six months and is less regulated than NASDAQ, as Sarbanes-Oxley and SEC regulations are not involved. AIM also has smaller costs and fees, a lower threshold for listing, and a broad international mix of companies.
When it comes to funding, a good location indirectly helps. Naturally, companies in locations with a strong pharmaceutical industry, human capital, and support infrastructure have an advantage. Beyond that, some countries like Singapore and some U.S. states like California are funding stem cell initiatives.
If the other infrastructure is lacking, however, the funding can be largely irrelevant in producing viable results. “The money hasn’t really materialized,” Fambrough concludes.
Added On April 30, 2010
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