HM International Blog

Celsion Corporation (NASDAQ: CLSN) announced today that it has received official approval from China’s State Food and Drug Administration (“SFDA”) for its Clinical Trial Application for ThermoDox that permits Celsion to include Chinese clinical trial sites in its Phase III ThermoDox HEAT trial for the treatment of primary liver cancer, also known as hepatocellular carcinoma (HCC).

Celsion’s global Phase III ThermoDox® clinical trial is evaluating the efficacy and safety of ThermoDox in combination with radiofrequency ablation (RFA) when compared to RFA alone. The trial will enroll up to six hundred patients and is currently being conducted in Japan, Hong Kong, Korea, Taiwan, Italy, the United States and Canada. In addition to China, Celsion expects to receive CTA acceptance in Thailand, Malaysia, and the Philippines during the fourth quarter of 2009 and will have up to sixty sites activated by the end of the year. Completion of patient enrollment is expected to occur in the first half of 2010.

“Acceptance of our CTA in China is an important milestone for Celsion because China represents a significant market opportunity for ThermoDox”, stated Michael H. Tardugno, Celsion’s President and Chief Executive Officer. “The incidence of HCC in China is growing faster than any other country at over 350,000 patients per year (55% of world’s total incidence) and the use of RFA is becoming the standard of care for the treatment of early-stage HCC.

Concurrent with sFDA’s review of our application, we have identified and qualified rapid start-up sites in China which should enable patient enrollment to commence in the near-term. The expansion of the trial to China not only accelerates patient enrollment, but builds on our global strategy to conduct our Phase III trial in regions where the incidence of HCC is significant. Our goal is to enroll patients in key markets outside of the United States to facilitate regulatory approval in multiple countries, mainly East Asia, where the incidence is among the highest in the world.”

Henry Markram, director of the Blue Brain Project, has already simulated elements of a rat brain. He told the TED Global conference in Oxford that a synthetic human brain would be of particular use finding treatments for mental illnesses. Around two billion people are thought to suffer some kind of brain impairment, he said. “It is not impossible to build a human brain and we can do it in 10 years,” he said. “And if we do succeed, we will send a hologram to TED to talk.”

Shared fabric
The Blue Brain project at Swizerland’s EPFL (École Polytechnique Fédérale de Lausanne) was launched in 2005 and aims to reverse engineer the mammalian brain from laboratory data.In particular, his team has focused on the neocortical column – repetitive units of the mammalian brain known as the neocortex.

The team are trying to reverse engineer the brain. “It’s a new brain,” he explained. “The mammals needed it because they had to cope with parenthood, social interactions complex cognitive functions. “It was so successful an evolution from mouse to man it expanded about a thousand fold in terms of the numbers of units to produce this almost frightening organ.”

And that evolution continues, he said. “It is evolving at an enormous speed.” Over the last 15 years, Professor Markram and his team have picked apart the structure of the neocortical column. “It’s a bit like going and cataloguing a bit of the rainforest – how many trees does it have, what shape are the trees, how many of each type of tree do we have, what is the position of the trees,” he said.

“But it is a bit more than cataloguing because you have to describe and discover all the rules of communication, the rules of connectivity.”The project now has a software model of “tens of thousands” of neurons – each one of which is different – which has allowed them to digitally construct an artificial neocortical column.

Although each neuron is unique, the team has found the patterns of circuitry in different brains have common patterns. “Even though your brain may be smaller, bigger, may have different morphologies of neurons – we do actually share the same fabric,” he said. “And we think this is species specific, which could explain why we can’t communicate across species.”

Soon, every senator and representative must decide where they stand. Lobbyists will be racing to each office, trying every trick in the book to derail the President’s plan. In fact, just this week, the insurance lobby released a self-serving report falsely claiming that reform would increase costs. Journalists called it “deceptive” and said “something doesn’t smell right here.” A prominent M.I.T. economist described the study as “deeply flawed.”

It’s a blatant scare tactic designed to frighten voters and bully Congress — and it’s just the beginning. We need to speak out right away to show Congress that their constituents are watching closely, and we’re counting on them to say “no” to the lobbyists and “yes” to reform.

Send a message urging Congress to stand with voters, not D.C. lobbyists, and pass real reform.
It’s becoming clear that the insurance companies will do whatever it takes to stop progress: The New York Times is reporting that special interests are spending $1.4 million every day to kill reform — and even commissioned their own slanted analysis of the Finance Committee’s legislation in an effort to defeat it. But today, after widespread criticism, the company that produced the report issued a statement saying that it analyzed only part of the bill because that’s exactly what the insurance industry paid them to do!

And we just got word that insurance companies are spending $1 million on a misleading ad to scare seniors out of supporting reform. The ad falsely declares that reform will cause cuts in Medicare, even though reform is crucial to ensuring the long-term survival of the program and preserving the care that millions of seniors depend on.

Now that all five congressional committees have passed reform legislation, we’re sure to see attacks that are even more extreme. It’s up to us to make sure that ordinary Americans continue to be heard louder than the Washington lobbyists.

The Megaframe project scored a staggering number of breakthroughs to create the world’s first 1024 pixel, photon-resolution, million-frame-per-second CMOS camera that puts Europe firmly in the lead for ultra-high speed video cameras.

Their work has pushed the boundaries of CMOS (a type of semiconductor) miniaturisation and sophistication. But it is in the application of their technology that the most stunning impacts of the Megaframe project will be seen, particularly in medical applications.

That is because the camera can detect a single photon at a million times a second, and so it can record molecular processes in unprecedented detail. “We need this sort of detail because biomedical scientists are studying processes at the intra-cellular and molecular levels,” underlines Edoardo Charbon, coordinator of the EU-funded Megaframe project.

Ingenious
Scientists have developed extremely ingenious ways to infer or deduce what is happening at the molecular level, and Megaframe could make that process even more detailed. Essentially, scientists use a variety of emissive materials to see what is happening in microscopic biomedical processes.

Take Fluorescence Lifetime Imaging Microscopy (FLIM). Here, a fluorescent material is introduced to the area of interest. Fluorescence has some interesting properties, for example a particular spectrum of emission and a rate of decay.

One particular fluorophore, Oregon Green Bapta (OGB-1), decays at a rate proportionate to the presence of calcium. Interestingly, calcium is an important indicator of neuron activity.

“So it is possible, for example, to go inside neurons and look at their ion channels. These are the channels that allow neurons to communicate with other neurons. And you can basically see the amount of calcium that is present. You can probe optically how neurons communicate with other neurons just by looking at the concentrations of calcium in real time,” explains Charbon.

So scientists can use the OGB-1 to indicate the presence and concentration of calcium, and the whole process can be recorded in ultra-fine detail thanks to single-photon detectors, such as the ones present in the Megaframe camera. The camera is recording at the speed of thought.

“Biomedical scientists could in principle use this microscopic information about calcium to learn about macroscopic conditions like Parkinson’s, or Alzheimer’s or epilepsy,” Charbon stresses.

But that’s just the beginning. Megaframe could have a significant impact on any medical science that uses visible light emissive scanning technologies like FLIM. But it can even have an impact where visible light is not present.

In a review of four clinical trials, researchers found that smoking-cessation programs that included text-messaged advice doubled the chances that smokers would be able to kick the habit for up to a year.

The programs, conducted in New Zealand, the UK and Norway, used text messages as a way to give smokers daily advice and encouragement. The programs also offered support when quitters needed it the most; if they found themselves craving nicotine, for example, they could text “crave” to the program and get immediate advice on what to do.

Two of the studies looked at programs that only involved text messages, finding that the service doubled the odds that smokers would quit over six weeks.

The other two studies focused on a program in Norway that used text messages, emails and a dedicated Web site; it found that smokers who used the program were twice as likely to report abstinence for up to one year.

The findings appear in the Cochrane Library, a publication of the international research organization the Cochrane Collaboration.

Kicking the smoking habit is notoriously difficult, and text messaging is no magic bullet. Most of the roughly 2,600 smokers across the studies did not succeed in quitting, regardless of whether they had text-message help.

But text messages could serve as one more tool in the smoking-cessation arsenal, according to lead researcher Dr. Robyn Whittaker, of the University of Auckland in New Zealand.

“We know that stopping smoking can be really difficult and most people take several attempts to quit successfully,” Whittaker told Reuters Health in an email. “And so I think it is important to be able to offer lots of different options for extra support.”

Text messaging may be effective for some people, in part, because they can get help right at the time when cravings strike, according to Whittaker.

“The frequent messages can also act as a good reminder and motivation to keep going,” Whittaker added.

One of the programs in the study, called Txt2Quit, is already up and running in New Zealand, with government funding. Smokers seeking to quit can sign up for the free 26-week program, which automatically sends users two to three text messages per day shortly before their designated “quit date,” and for one month afterward. After that, they receive three text messages a week.

A recent study of people who participated in the program’s first year found that one-third were abstinent four weeks after their quit date. That figure dropped to 16 percent after 22 weeks.

It’s estimated that only about 5 percent of smokers are able to kick the habit without any help.

NEW YORK (Reuters Health) – Two drugs used to prevent malaria in travelers appear to have a lower risk of side effects than a third commonly prescribed medication, according to a research review published Tuesday.

The review looked at eight clinical trials of various anti-malaria drugs — including mefloquine, atovaquone-proguanil and the antibiotic doxycycline. All three are considered drugs of choice for travelers heading to most malaria-endemic regions.

However, the study found, both atovaquone-proguanil — sold under the brand-name Malarone — and doxycycline appear to have fewer side effects.

With these two drugs, there is lower risk of nausea, stomach pain and other gastrointestinal side effects, and also neurological and psychiatric side effects, such as dizziness, sleep disturbances, anxiety and depression.

There were no severe side effects — problems that were life-threatening or required hospitalization — in any of the studies.

The investigators did, however, find published case reports linking mefloquine to 22 deaths, including five suicides. No other anti-malaria drugs have been linked to deaths when taken at prescribed doses, the researchers note in their review, published in the Cochrane Library, a publication of the Cochrane Collaboration, an international organization that evaluates medical research.

Despite the higher risk of side effects with mefloquine, the findings do not necessarily mean that travelers should avoid this drug, according to the researchers.

Doctors prescribe anti-malaria medications based on a number of factors — including which country travelers are visiting — and mefloquine may still be appropriate, particularly for people who have taken it before without problems.

“The main message is that you have to take some malaria chemoprophylaxis (preventive treatment) if you go to an endemic area,” lead researcher Dr. Frederique Jacquerioz, of Tulane University in New Orleans, noted in a written statement. “It’s one of the best preventive measures we have.”

Caused by a mosquito-borne parasite, malaria is endemic in large areas of Africa, Asia and South and Central America, where it kills about 1 million people a year.

An estimated 10,000 to 30,000 travelers develop malaria every year, of whom about 150 die.

When it came to side effects, however, Malarone was about half as likely as mefloquine to cause gastrointestinal side effects, and 14 percent to 50 percent less likely to have a neurological or psychiatric side effect.

In one study, 69 of 493 Malarone users developed some type of neuropsychiatric side effect — including dizziness, insomnia or strange dreams. That compared with 139 of 483 mefloquine users.

Similarly, doxycycline users had a 16 percent lower risk of neurological or psychiatric symptoms.

Still, severe reactions to mefloquine are rare, noted Dr. Andrea Boggild of Toronto General Hospital in Canada, who was not involved in the study. In a written statement, Boggild said that severe neurological and psychiatric symptoms develop in just one out of every 6,000 to 10,000 people who take the drug.

Boggild advised people who are planning a trip to a malaria-endemic area to talk with a healthcare provider who specializes in travel medicine about how to best protect themselves.

Annual Import of Medical Equipment in India
India’s top defence scientist A P J Abdul Kalam deplored the premature junking of nearly Rs 70 billion worth of medical equipment annually imported into the country.

Adressing a conference in New Delhi, Kalam offered the services of the defence laboratories in restoring valuable equipment which was being junked only for want of routine maintenance.

He also suggested the creation of a body of trained personnel whose responsibility it would be to keep medical equipment up to date rather than expend valuable foreign exchange on continued and avoidable imports.

The scientist said there were meeting points between medicine and technology which could be used to benefit ordinary people and hoped that the All-Indian Institute of Medical Science would take a lead in the area.

Medical knowledge combined with technology excellence has provided leverage for finding solutions for complicated health problems, he noted.

Another emerging concept which could be of value for remote populations was tele-surgery where surgery can be conducted by a specialist doctor through remotely controlled micro-robots from a distance.

The Society for Biomedical Technology, an inter-ministerial initiative, was born to utilise research and technology spin-offs from defence laboratories to bring medical care to ordinary people.

TheNoble Prize2009 in Physiology or Medicine goes to three American scientists Elizabeth H. Blackburn, Carol W. Greider and Jack W. Szostak, who solved a major puzzle in biology; they discovered that chromosomes don’t degrade when they replicate because it’s all to do with how telomerase makes telomeres to protect the ends of the chromosomes. Their discoveries led to a new understanding of how cells work and opened new avenues for researching and treating many diseases. The Nobel Assembly at Karolinska Institutet in Stockholm, Sweden, announced on Monday that the three Nobel Laureates won their award for the discovery of “how chromosomes are protected by telomeres and the enzyme telomerase”.

The genes that make up our genome are the blueprint of our biology. They are made of two intertwined strands of DNA written in an alphabet comprising just four base codes, packed into chromosomes with telomere “caps” on their ends. The three Nobel Laureates discovered that telomeres contain a unique sequence of DNA code that stops the chromosomes from degrading as they reproduce. This has opened the door to developing new treatments for diseases.

Cells age as telomeres get shorter, and conversely, they don’t age when telomerase activity is high and protects telomere length. This property is reflected in various diseases. For example, cancer cells are considered to have eternal life because their telomere length is preserved when they replicate, while certain other diseases are characterized by defective telomerase, resulting in damaged cells.

operated upon two-year-old Lakshmi — a conjoined twin.

A beaming team of doctors headed by Dr Sharan Shivraj Patil announced on Wednesday morning that the 27-hour-long surgery had been completed and Lakshmi was safe now. The doctor was, however, quick to add that she was still under observation.

One of the twins is headless and has two pairs of arms and legs. The villagers offered to build a temple in her name and there was also a circus company, which had offered the parents a lot of money, if they gave her to them.
Lakshmi’s father Shambu said this was the biggest Diwali gift. “Lakshmi was born two years ago on Diwali and this year, she is okay. What more can I ask for,” Shambu said.

Dr Patil said doctors were very excited and did not intend to go home for the next two days. The biggest challenge was to maintain stability in the child while the operation was being performed, he said, adding that another achievement was that they did not jeoparadise any aspect of Lakshmi during the operation.

his is a rare condition and such surgeries take place only once in 50,000 cases. There have been similar cases in the past, but the success rate has been negligible.

Benefits
» Amplification is up to 18 times greater than the best non-electronic stethoscopes.
» Ambient Noise Reduction (ANR) technology.
» LCD display in chestpiece, including heart rate readout.
» Recording and playback capability at normal and half-speed.

Suggested Applications
» Used as a diagnostic aid as part of the physical assessment of a patient.
» Recommended for cardiology and high-performance adult and pediatric use.
» A tool for telemedicine.
» A teaching tool.

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