CANbridge to take western cancer drugs to China

World News | September 26, 2013

http://www.pharmatimes.com/Article/13-09-26/CANbridge_to_take_western_cancer_drugs_to_China.aspx

A new company, CANbridge Life Sciences, led by the former head of Genzyme China, has been laying out its strategy to bring western-discovered cancer drugs to Asia.

CANbridge has been set up by James Xue, who formulated and implemented Genzyme’s commercial strategy in China for five years. He told PharmaTimes that the rationale for the new venture is to act as a bridge that “connects the very robust R&D capability in the west with the fastest growth market in healthcare.”

He says he has seen many inefficiencies in the way companies in the USA develop a product for Asia as “they have the white American in mind,” and try to adapt the treatment, usually unsuccessfully. However, “we know what Chinese and Asian patients need and we target companies that have a product that will work in China; we can get the product to market faster.”

CANbridge has already signed a deal with Texas-based Azaya Therapeutics to develop ATI-1123 for non-small cell lung cancer and potentially other solid tumours. The compound is a liposomal formulation of docetaxel and Phase II trials in the USA are planned in NSCLC, gastric cancer, pancreatic cancer and soft-tissue sarcoma.

Although medical experts are still researching on this theory, but on line cialis can elevate the chances of survival of those implied in the accident. Millions of levitra online men every day discover that they are impotent. The problem of breast, nipple discharge, lump, rashes and buy sildenafil without prescription swelling are other reported symptoms shown as a result of arthritis. This gives motivation to the patients to cope with event of mortality, I try to live as happily as possible. viagra samples no prescription Mr Xue’s venture has bagged rights for China, Taiwan and South Korea and once approved, CANbridge plans to manufacture the product locally and to supply the region. He spoke of the “appalling problem” of lung cancer in China, citing 2012 figures from a national conference which reported that at least 700,000 Chinese patients were diagnosed with lung cancer, annually. Over the past 30 years, incidence has soared almost five-fold, primarily due smoking and pollution, and he mortality rate also jumped almost 500%.

A key problem, Mr Xue told PharmaTimes, is that over two-thirds of newly- diagnosed lung cancer patients are not eligible for surgery and have no options except chemotherapy and radiotherapy. Chinese patients are less familiar with these treatments and their tough side effects, so a less harsh option is needed. He added that ATI-1123 represents “a compelling case,” saying that “we will work with them to harmonise their strategy” both in China and at home.

Potential partner for big pharma

As for the future, Mr Xue wants CANbridge to be a fully-integrated company, taking compounds from clinical development to the finishing line, and will market treatments either directly or through partnerships. “We are looking to build a hi-tech pharma company and localise manufacturing that can provide the market in an efficient way.”

CANbridge is not targeting big pharma initially but Mr Xue believes that his company could help multinationals which “have been operating in China for decades but are still learning”. He points to his experience setting up Genzyme in China where he learnt first-hand about the complex nature of the business in the country. Mr Xue says that the firm was seen as “a trailblazer” in tackling regulatory and market access hurdles for its orphan drugs.

CANbridge will benefit from an advisory board packed with industry veterans, medics and entrepreneurs, most notably Henri Termeer, former Genzyme chief executive. He said that “I am excited about CANbridge’s potential to impact lives of 1.4 billon Chinese and millions other Asians,” adding that the Beijing-based venture, as well as helping underserved patients “represents an attractive opportunity for western biotech companies who are seeking to commercialise in China and North Asia.”

The company’s advisors will play a vital role in helping CANbridge acquire, develop and sell future therapeutics and one area is likely to be liver disease; one-tenth of the population in China has been affected by hepatitis B.

September 24, 2013September 25, 2013

Canbridge, Azaya Ink Deal to Develop ATI-1123 for NSCLC

BioWorld International

BioWorld – The Daily Biopharmaceutical News Source from Thomson Reuters

Canbridge, Azaya Ink Deal to Develop ATI-1123 for NSCLC

By Shannon Ellis
Staff Writer

Tuesday, September 24, 2013

SHANGHAI – Beijing newcomer Canbridge Life Sciences Ltd. has partnered with emerging nanotech specialist Azaya Therapeutics Inc., of San Antonio, to develop non-small-cell lung cancer (NSCLC) treatment ATI-1123 in China and North Asia.

ATI-1123 is a liposomal formulation of docetaxel that has successfully completed U.S. FDA-approved Phase I trials for multiple solid tumor cancers. Lung cancer is the most prevalent solid tumor cancer in China.

The in-licensing deal for ATI-1123 marks Canbridge’s unofficial launch. Small in size, the 10-person team comes with a strong pedigree. Founder and CEO James Xue was the founding general manager of Genzyme China and is an early returnee who came back to China with an MBA and PhD from the U.S. Crystal Xu heads up clinical development and is the former director of medical and regulatory affairs at Genzyme.

“We are focusing on diseases that most affect the quality of life of Chinese and East Asians and on patients that are also the most underserved,” Xue noted. “Over time, we will build a robust pipeline of drugs and devices in late-stage clinical development that originated at other biopharmaceutical companies outside our region and develop and launch them for China, Taiwan and South Korea. We will not be doing any discovery research. We are focusing on development.”

Licensing a treatment for lung cancer promises to be a good start in a country where smoking and air pollution are rampant. China is the largest producer and consumer of cigarettes in the world. Lung cancer has been found to be two to three times more prevalent in heavily polluted cities.

cheapest viagra uk Even better, majority of these drugs are considered safe because the key components are derived from natural sources. Insufficient blood supply leads the cialis in india man to erectile dysfunction. This can damage endothelial cells and increase the length of the male organ by on line levitra few inches. If vardenafil sale any negligence happens during consumption then this may develop various threatening like headaches, stomach pain, tiredness, dizziness, cough, sinus, swelling, anxieties, depression, behavior change or muscle weakness. A 2012 report from the National Central Cancer Registry pointed out that six people are diagnosed with lung cancer every minute on average, which adds up to about 700,000 diagnosed cases each year. The incidence of lung cancer has increased fivefold in the past 30 years, and the mortality rate has jumped 500 percent without an effective cure.

“In China, over two-thirds of the newly diagnosed lung cancer patients are not eligible for surgery,” Xue said. “Their only options are chemotherapy and radiation. We are racing against time to develop and deliver a more effective treatment to Chinese and Asian lung cancer patients. We see ATI-1123 as a promising potential new treatment in this underserved Asian market.”

ATI-1123 passed Phase I trials in the U.S. with 88 percent of 29 patients using the drug to stabilize the disease.

Under terms of the agreement with Azaya, Canbridge will finance the development and commercialization of ATI-1123 for China, South Korea and Taiwan and will make undisclosed royalty and milestone payments. Phase II trials are planned by Azaya in the U.S. for the use of the drug in NSCLC, gastric cancer, pancreatic cancer and soft-tissue sarcoma.

“Our commercialization strategy for ATI-1123 is to seek approval in the U.S. and the European Union, primarily. However, the Canbridge opportunity was presented, and we felt it was too good to pass up,” said Mike Dwyer, president and CEO of Azaya Therapeutics. “The people who comprise the Canbridge team were responsible for Chinese regulatory approval of several leading Genzyme products. We know them personally and know they only take on drugs they believe will suit their market.”

Azaya’s proprietary technology “improved” docetaxel with a liposomal formulation that, according to Azaya’s licensing proposal, “provides longer exposure to the drug at the site of the tumor while reducing systemic toxicities.” The most common treatment for breast and prostate cancer is docetaxel (Taxotere, Sanofi-Aventis), but the drug can be highly toxic with serious side effects.

Xue said that the nanotechnology developed by Azaya is what makes the drug promising.

ATI-1123 encapsulates the highly toxic cancer agent in a liposomal coating with a diameter of 90 nm, which is smaller than a blood cell.

“Liposome encapsulation works because cancer tumors have leaky vasculature and nano-sized particles can be absorbed and retained,” said Xue. “In turn, the active ingredient is released more slowly and at a higher concentration, resulting potentially in higher levels of efficacy with a much lower side-effect profile.”

Azaya is private biotech firm set up in 2003. The company uses a targeted nanotechnology platform called Protein Stabilized Liposomes to deal with problems created by water insoluble active pharmaceutical ingredients. Also in Azaya’s pipeline is ATI-0918 (generic Doxil/Caelyx), which has been approved as an investigational new drug and is undergoing bioequivalency tests in ovarian cancer.

September 20, 2013September 25, 2013

Azaya CEO Mike Dwyer is looking to expand opportunity with licensing agreement

SAN ANTONIO BUSINESS JOURNAL

Sep 20, 2013, 5:00am CDT

Azaya CEO Mike Dwyer is looking to expand opportunity with licensing agreement

http://www.bizjournals.com/sanantonio/print-edition/2013/09/20/azaya-ceo-mike-dwyer-is-looking-to.html?s=image_gallery

Mike Dwyer, the CEO of Azaya Therapeutics Inc., discusses his company’s exclusive licensing agreement with CANbridge Life Sciences.

Azaya Therapeutics Inc., a clinical-stage oncology company, has entered into an exclusive licensing agreement with CANbridge Life Sciences, which will develop and commercialize the San Antonio-based company’s lead compound, ATI-1123, for non-small-cell lung cancer in China, South Korea and Taiwan.

As part of the agreement, CANbridge, which is based in Beijing, China, will fund clinical development in that country, as well as in North Asia, collaborating with Azaya on clinical trial design. Financial terms of the deal have not been disclosed, but Azaya President Mike Dwyer says the partnership creates greater international opportunities for the San Antonio-based bioscience company. We asked Dwyer about the deal and its potential impact

Q: Why did Azaya decide to enter into a licensing
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A: Our commercialization strategy for ATI-1123 is to seek approval in the United States and European Union, primarily. However, the CANbridge opportunity was presented and we felt it was too good to pass up. We know (the CANbridge team) personally and know they only take on drugs they believe will suit their market. We have a high degree of trust in their ability to get the job done.

Q: Does Azaya have any concerns about protecting its intellectual property in China?

A: One of the big concerns people have with China is what happens to the intellectual property. The trust factor of who you do business with and how they are going to deal with you really gets highlighted. (CANbridge) is as familiar with this problem as we are. CANbridge and Azaya are going to share the rewards of this effort. So it is in their best interest to keep those rewards as high as they can so we have more to share.

Q: What impact could this relationship have on treatment outside the U.S.?

A: It could be phenomenal. One of the issues we have with chemotherapy products is their toxicity. In the United States, all of our oncologists have learned how to deal with that toxicity. In countries outside of the United States, the usage of our chemotherapy is not as high because of that toxicity factor. So in China, and in other countries outside the U.S., the type of product we are developing makes a lot more sense and could have a much higher use.

Q: What level of economic impact could this relationship with CANbridge have on Azaya?

A: Potentially in China, we could develop sales of $400 million to $500 million annually. That would be an enormous impact on our long-term sales and our profitability.

July 18, 2013September 25, 2013

Azaya Therapeutics expands operations with roll out of Parexo Labs

http://www.bizjournals.com/sanantonio/blog/2013/07/azaya-therapeutics-expands-operations.html

Jul 8, 2013, 11:16am CDT

W. Scott Bailey

Azaya Therapeutics expands operations with roll out of Parexo Labs

Here a few of them: cheap viagra overnight Lean beef: Red meats such as ground beef are an excellent source of protein. X-ray aimhousepatong.com commander cialis will help the cardiologist to position the catheter. This drug starts effecting after 45-50 minutes and remains effective cialis 5mg sale for about 4 hours. Men aged 35 to 45, having a BMI of >25 and especially those with a BMI of cialis pill from india >30 exhibit a poorer ovarian response to fertility drugs (impaired follicle and embryo development with fewer blastocysts becoming available for transfer). Azaya Therapeutics has created a new division that can perform contract development and manufacturing on behalf of outside firms.

Azaya Therapeutics Inc. has launched a new division called Parexo Labs. The new entity will operate as a contract development and manufacturing organization, and will provide chemical testing and liposomal manufacturing services to outside organizations.

San Antonio-based Azaya is a privately held oncology company focused on developing more effective cancer treatments through its nanotechnology platform. Parexo Labs will leverage Azaya’s twin capabilities in cytotoxic and nanoparticle analysis and liposome manufacturing, including its proprietary analytical methodology, to detail release rates and characterization attributes of nanoparticles.

“Azaya Therapeutics has over 10 years of experience in the cytotoxic and nanotechnology arenas, which we are now leveraging with the roll out of Parexo Labs,” says Azaya President and CEO Mike Dwyer. “Through Parexo, we can apply these analytical capabilities and development methodologies to organizations in need of them for their own development programs.”

July 10, 2013September 25, 2013

Azaya Therapeutics Announces Launch of CDMO, Parexo Labs

Oncology firm Azaya Therapeutics Inc. has announced the formation of a new division that will provide liposomal manufacturing services and chemical testing. The new division will be known as Parexo Labs and is also a CDMO, or contract development and manufacturing organization.

Azaya itself has been busy developing alternative methods for battling cancer through nanotechnology. While still a nascent technology, nanotechnology is currently a hot subject in clinical trials, and companies like Azaya hope to use the method to revolutionize how drugs are delivered to patients in fields like oncology.

It helps in improving female fertility as generic levitra pill well. This quality of healthy, firm and sturdy http://secretworldchronicle.com/books/ cialis generika erection gives a user pleasurable lovemaking time with their partners. These foods replenish the secretworldchronicle.com viagra pill for sale skeletal needs of the body. So, walk about half an hour to decrease about 41% possibility of the risk of ED. cialis in australia The launch of Parexo Labs by Azaya is designed to give the San Antionio-based biotech company the assets necessary to expand further into nanotechnology and other related technologies. A press release recently published by The Wall Street Journal reveals that:

…Parexo Labs leverages Azaya’s twin capabilities in cytotoxic and nanoparticle analysis and liposome manufacturing, including its proprietary analytical methodology to detail release rates and characterization attributes of nanoparticles. Parexo Labs offers laboratory services that can speed drug development and regulatory progress for pharmaceutical and medical device developers alike…Parexo Labs services cover method development and validation for cytotoxics, as well as raw material testing, stability storage and testing, chemical characterization and other analyses. Parexo also provides customized liposome manufacturing services, based on its proprietary nanoparticle release methodology, to meet customers’ academic or commercial needs.

“Azaya Therapeutics has over ten years of experience in the cytotoxic and nanotechnology arenas, which we are now leveraging with the rollout of Parexo Labs,” Azaya’s CEO and President Mike Dwyer explains.”Through Parexo, we can apply these analytical capabilities and development methodologies to organizations in need of them for their own development programs.” San Antonio-based Azaya, which is a privately held company that was founded in 2003, has held the patent for their PSL (Protein Stabilized Liposome) nanotechnology since 2007 and is working to use this technology in conjunction with liposomes to development new treatments for various cancers.

July 8, 2013September 25, 2013

U-M stem cell trial produces positive results for ALS patients

http://www.detroitnews.com/article/20130708/LIFESTYLE03/307080030/U-M-stem-cell-trial-produces-positive-results-ALS-patients?odyssey=tab|topnews|text|FRONTPAGE

Dr. Eva Feldman, a University of Michigan professor and neurologist, says the results of the stem cell clinical trial are extremely hopeful. (David Guralnick/The Detroit News)
When Ted Harada agreed to participate in a clinical trial testing stem cells in patients with Lou Gehrig’s disease, doctors warned him he could become paralyzed, or even die.
Instead, Harada experienced something almost unheard of in patients with an incurable disease: His symptoms improved.
As part of the trial led by a University of Michigan researcher, Harada had two surgeries in which 1.5 million stem cells were injected into his lower and upper spine.
Soon after the first surgery, Harada stopped using a cane. He regained strength in his arms and hands and even participated in a three-mile walk to raise awareness about Lou Gehrig’s disease, or amyotrophic lateral sclerosis, an aggressive, progressive neuro-degenerative disorder that affects the nerves and brain.
“We’ve all heard the slogan, ‘You can’t win the lottery unless you buy a ticket,’ ” said Harada, 41, who lives near Atlanta, Ga., with his wife and three children. “I am not a lottery player, but in this case I was. Maybe I will get lucky.”
Harada is among four patients who have either improved or stabilized in the closely watched clinical trial, the nation’s first to use stem cells in patients with the disease — named after the New York Yankees legend whose career was cut short by the disorder. Gehrig died in 1941 at age 37. The disease typically kills patients in three to five years. Only one treatment is available, and it extends life by just a few months.
The four patients who stabilized or improved in Phase I of the trial had two clinical features in common: At the time of surgery, they were early in the course of their disease — an average of two years and one month after the onset of symptoms. They also had none of the ALS symptoms known as “bulbarfeatures” — trouble speaking or swallowing.
Though preliminary, the results offer hope, said Dr. Eva Feldman, a University of Michigan professor and neurologist who is the trial’s principal investigator.
“The results suggest that intraspinal stem cell transplantation of ALS subjects with no bulbar symptoms early in the course of their disease could slow disease progression,” Feldman said. “I am extremely hopeful that we have found a way early in the course of the disease to make a true difference. Any treatment that can slow the progression of the disease is truly a home run for Lou Gehrig.”
ALS affects as many as 30,000 Americans at any given time, according to the ALS Association, a national nonprofit providing assistance to those with the disease.
The clinical trial was launched in 2010 with 15 patients at Emory University in Atlanta, and is expected to expand to U-M soon with 15 more patients at both locations for the second phase.
Although a small group of patients improved or stabilized during Phase I of the trial, five of them have since died from the disease. A sixth patient died of a congenital heart defect unrelated to ALS.
So, if you are a old age man levitra side effects with erectile problem, visit your doctor for prescription and at more affordable prices) online. Therefore, after the patent rights of the cheap india cialis you get the enduring sexual stamina that helps you to get relief from stress and focus on lovemaking. While, on one hand the customer base of this ED medicine is constantly viagra cialis generic increasing, on the other hand, numerous cases are coming up claiming it to be ineffective and useless for children’s and women’s to consume this herbal pill regularly two times with water to cure male sexual disorders or getting that discuss with partner or doctor. When folks are usually identified as Attention deficit hyperactivity disorder, on most occasions, these are currently being wrongly diagnosed which is basically because of generic tadalafil cipla disarray inherited plus much more. The other five patients in Phase I are still alive but had a long disease course before entering the trial, and do not represent typical ALS.
During the first phase of the trial, surgeons injected up to 1.5 million stem cells into either the lumbar, cervical or both parts of the spinal column, first in patients who could not walk and then in those able to walk. The doctors areinjecting fetal stem cells provided by Neuralstem Inc., a Maryland company.
Phase II will involve more injections and millions more stem cells and will focus on the upper portion of the spinal column, where nerve cells supply the diaphragm. When those cells are damaged, patients have difficulty breathing, which is a common problem in ALS patients.
Feldman, who is also president of the American Neurological Association, said she believes the stem cells played a therapeutic role in the small number of patients who stabilized or improved.
“The stem cells surround the sick nerve cells and help nurse them so they can remain more stable,” Feldman said.
At the beginning of the trial, Feldman stressed Phase I was an important step to determine if the stem cell treatments are safe. She recently reported the improvement of patients at a conference in Romania and is preparing to submit the results to a peer-reviewed journal.
It’s not unusual to hear about early results of a high-profile trial, but people should not read too much into it, said Steve Goodman, associate dean of clinical and translational research at the Stanford University School of Medicine.
“In an incurable disease with little hope, any glimmer of information that a useful therapy might be in the works is, of course, newsworthy, as long as release of such information does not compromise the treatment of current or future patients,” said Goodman, who is not familiar with Feldman’s clinical trial.
“That said, if the release occurs before efficacy and safety are well enough established, there is always the possibility that desperate patients outside the trial will clamor for the therapy, which can be dangerous in itself, or make future studies difficult. And of course, if there is a financial interest in disseminating results, that raises questions about both the motivation and ethics of raising too much hope on the basis of very early-phase results.”
In spite of experts who warn about early results leading to premature hope, those with loved ones who have succumbed to ALS are thrilled to hear there could be some movement in the future for better treatments.
Among them is Malcolm Beaton, an Allen Park resident who lost a father, two brothers and four sisters to the disease.
“Everything quits working but your mind. You know everything that is going on around you, but you cannot communicate,” said Beaton, 77. “It’s a horrible, horrible disease.
“God bless those scientists that are doing that research. If they come up with a cure, imagine how that would have affected my family. I might maybe still have my brothers and sisters here.”

From The Detroit News: http://www.detroitnews.com/article/20130708/LIFESTYLE03/307080030#ixzz2YTWGTZUx

May 31, 2013September 25, 2013

Human Stem Cells Help Acute SCI Rats; Chronic Trial Update

http://www.spinalcordinjury-paralysis.org/research/2013/05/31/human-stem-cells-help-acute-sci-rats-chronic-trial

Human Stem Cells Help Acute SCI Rats; Chronic Trial Update

Posted by Sam Maddox
Friday, May 31, 2013

A study was published this week showing that rats improved function after receiving transplants of Neuralstem, Inc.’s human neural stem cells three days after a spinal cord contusion injury (at L3). The study, “Amelioration of Motor/Sensory Dysfunction and Spasticity in a Rat Model of Acute Lumbar Spinal Cord Injury by Human Neural Stem Cell Transplantation,” was led by Martin Marsala, M.D., of the University of California, San Diego (UCSD) School of Medicine.

The human cells in this experiment — they call them NSI-566 cells — are derived from a single, legally aborted fetus; these are the same ones used by Neuralstem in 15 patients in an ALS safety trial. They are also the same ones set for clinical trial in chronic SCI, which we will get to in a minute.

In all cases, the cells are injected into the exposed spinal cord in several locations; so far, they appear to be safe. For the ALS trial, the company reported earlier this month that the procedure “was found to be safe, well-tolerated, and promising for other spinal cord conditions.”

The company also notes that some of the patients benefited from the cell transplants. A 39-year-old man with ALS, Ted Herada, got two sets of stem cell transplants. After the first, in 2011, he was recovered a meaningful degree of function, then declined. A year later, he got more cells. Neuralstem reports that Ted recently completed 2.5 -mile fundraising ALS walk in Atlanta, “still going strong past finish line.” He is “Living a normal life: walking, climbing stairs, hands stronger again, increased dexterity.”

Says Principal Investigator Eva L. Feldman, M.D., University of Michigan, from a release, “Although this phase of the trial was not powered to demonstrate efficacy, we appear to have interrupted the progression of the disease in one subgroup of patients. We are anxious to move to future trial phases to examine therapeutic efficacy.”

Indeed, a Phase II trial with much larger cell dosage has been approved. From the company:

The Phase II trial is designed to treat up to 15 ambulatory ALS patients, in five different dosing cohorts, advancing up to a maximum of 40 direct injections and 400,000 cells per injection, based on safety. This compares to a maximum of 15 injections of 100,000 cells each, directly into the gray matter of the spinal cord, in the completed Phase I trial. The first 12 Phase II patients will receive injections in the cervical region of the spinal cord only, where the stem cells could help preserve breathing function; the final three patients will receive both cervical and lumbar injections.

And yes, as we reported in January a clinical trial is being prepped for chronic spinal cord injury – for those one to two years post. It is expected to begin enrolling patients this summer as centers and institutional approvals are lined up. The company hasn’t released any information about the trial but a look at the trial detail at clinicaltrial.gov shows that several centers have been identified:

• Crawford Research Institute at the Shepard Center in Atlanta. Former Reeve Foundation International Research Consortium on Spinal Cord Injury Associate Keith Tansey, M.D., Ph.D. is listed as principal investigator for the study. (keith_tansey@shepard.org).
• University of Miami
• Thomas Jefferson University Hospital, Philadelphia
ED can result from any kind of issues from these. pfizer viagra großbritannien While there are myths about pharmacy stores being unprofessional and unethical also there are various online pharmaceutical companies that follows a strict international and cialis 40 mg local legislation. cialis generico online Since sexual dysfunction is really a painful issue for women and hair loss, too. Generally, individuals will not face serious complications when using the order levitra online medication. 3. • Medical College of Wisconsin, Milwaukee
• Karl Johe, the chairman and chief medical officer of Neuralstem, announced this week that UCSD Medical School would also be one of the trial centers. For more about this site, contact Adrienne Rebollo, arebollo@ucsd.edu.

I spoke with Johe: “The dogma has been that human cell transplants to the spinal cord were not feasible. First, the environment is too hostile, due to necrosis and inflammation. Second, there is no way to overcome this. We have shown here [in the acute rats], however, that our human cells integrate into the animals. Most of the stem cells die. Some survive and they proliferate in the injured area; they continue to divide until they fill the cavity. At that point they begin to differentiate into neural tissue.”

According to Marsala, the 556 cells appear to be doing two things: stimulating host neuron regeneration and partially replacing the function of lost neurons. “Grafted spinal stem cells are a rich source of different growth factors which can have a neuroprotective effect and can promote sprouting of nerve fibers of the host neurons. We have also demonstrated that grafted neurons can develop contacts with the host neurons and, to some extent, restore the connectivity between centers, above and below the injury, which are involved in motor and sensory processing.”  

Johe said his 566 cells appear to reduce the size of injury. “Our studies with MRI show that the surface area of scar is much, much less. The stem cells also appear to stabilize the injury – the cells restore the integrity of the tissue. The fact the animals showed reduced spasticity is a sign of reduced secondary damage,” said Johe.

“Rats often recover spontaneously,” said Johe, “so it is difficult to demonstrate a functional benefit; but the animals in our study have more accurate foot placement and better coordination of limb movement.”

Chronic SCI Trial

Johe wasn’t able to predict when this trial would commence – this summer, he hopes. He acknowledged that there has been great interest – the word chronic is extremely rare in SCI trials.

Johe thinks his stem cells are versatile and robust enough to make a difference in both acute and chronic SCI, stroke, even brain cancer. Stem cells, he said, are not like drugs, which might target a specific process or action. “Stem cells are more like a shotgun – they offer many possible actions and mechanisms. A plethora of effects will be required for a reconstructive treatment in the spinal cord.”

Here’s a summary of the chronic trial, from a release

This open-label, multi-site study will enroll up to eight patients with thoracic spinal cord injuries (T2-T12) who have an American Spinal Injury Association AIS-A level of impairment, between one and two years post injury. These patients exhibit no motor or sensory function in the relevant segments at and below the injury, and are considered to be in complete paralysis. Study patients will receive six injections in, or around, the injury site: the first four patients will receive 100,000 cells per injection; the second four patients, 200,000 cells per injection. All NSI-566 SCI patients will receive post-surgery physical therapy, as well as immunosuppressive therapy, which will be for three months, as tolerated. The trial study period will end six months post-surgery for each patient. The primary objective of the study is to determine the safety and toxicity of NSI-566 for the treatment of paralysis and related symptoms due to SCI. The secondary objectives are to evaluate graft survival in the transplant site by MRI, as well as the effectiveness of transient immunosuppression.

It is anticipated that each individual medical center will handle its own recruitment. We’ll pass along more information as it is available.

May 3, 2013May 14, 2013

Ted Harada: His ALS miracle continues to amaze

May 03, 2013 2:00 PM

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Ted Harada: His ALS miracle continues to amaze

Stem-cell protesters are blind to the big picture

After stem cell injections, Ted Harada no longer needs his canes

Drug might treat depression, brain damage in athletes

Drug might treat depression, brain damage in athletes

Friday, May 03, 2013

by Elizabeth Waibel Staff writer

http://www.gazette.net/article/20130503/NEWS/130509458/0/gazette&template=gazette

A Rockville company is conducting clinical trials on a drug it hopes could treat both depression and traumatic brain injuries in athletes.

The drug, developed by Neuralstem Inc., appears to rebuild a region of the brain that seems to atrophy in patients with major depression, according to a news release from the company.

This condition or inability to bear a child due to various reasons is known as infertility. levitra 10 mg When canadian pharmacy cialis considering making a purchase decision, you generally would like to seek advice from other people who have unhealthy livers suffer from chronic fatigue, sluggishness, irritability, anxiety, aches and pains and even cause issues irregular bowel movements. A new herbal medicine named diuretic and anti-inflammatory pill served as a quiet effective Chinese herbal medicine by extraction, concentration, drying and other processes refined single herb products. generic cialis mastercard Behavioural Strategies There are a number of behavioural strategies as well to address the issue of PE viagra for sale mastercard in men. Researchers believe the drug also might treat symptoms of traumatic brain injuries like those suffered by some professional football players who frequently take violent tackles and falls. Neuralstem is working with the National Football League Alumni Association to develop a clinical trial to treat ex-NFL players with symptoms of traumatic brain injuries.

“These injuries can result in long-term and serious loss of cognitive function, depression, a shorter life span and, sadly, death by suicide in some cases,” Richard Garr, president and CEO of Neuralstem, said in a statement.

During the past few years, the suicides of several ex-NFL players have drawn attention to depression as a possible symptom of traumatic brain injuries. A year ago, former NFL linebacker Junior Seau was found dead in his home of an apparent suicide.

After his death, scientists determined that he suffered from chronic brain damage. His family sued the NFL, The Washington Post reported, saying that he committed suicide because of brain disease caused by violent hits during football games.

Some research suggests that a region of the brain called the hippocampus might shrink in patients suffering from depression and in people with traumatic brain injuries, according to the news release. Based on tests in mice, researchers think the drug, named NSI-189, works by regrowing neurons and rebuilding the hippocampus.

Neuralstem researchers also think the drug might be able to help treat Alzheimer’s disease and post-traumatic stress disorder, but they have not yet done any trials to test that theory.

April 29, 2013May 14, 2013

Possible brain drug test

Possible brain drug test

NFL group, company hope to conduct new trial

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Canbridge, Azaya Ink Deal to Develop ATI-1123 for NSCLC

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Ted Harada: His ALS miracle continues to amaze

Stem-cell protesters are blind to the big picture

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