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An Outcast Among Peers Gains Traction on Alzheimer's Cure
Some people collect stamps, others vintage cars. As a young Ph.D. student at Cambridge University in the 1980s, Claude Wischik was on a mission to collect brains.
It wasn't easy. At the time, few organ banks kept entire brains. But Dr. Wischik, an Australian in his early 30s at the time, was attempting to answer a riddle still puzzling the scientific community: What causes Alzheimer's disease? To do that, Dr. Wischik needed to examine brain tissue from Alzheimer's patients soon after death. That meant getting family approvals and enlisting mortuary technicians to extract the brains, he says, "no matter the time of day or night." And it wasn't just a few brains: he collected more than 300 over about a dozen years.
He also embraced an idea that, if he is right, could ultimately spin Alzheimer's research on its heels—and raise new hopes for the roughly 36 million people world-wide afflicted with Alzheimer's or dementia.
Alzheimer's researcher Claude Wischik has long backed a minority view: that a protein in the brain called tau-not plaque-is largely responsible. WSJ's Shirley Wang spoke with Dr. Wischik about his work on a new drug to treat the devastating disease.
The 63-year-old researcher believes that a protein called tau—which forms twisted fibers known as tangles inside the brain cells of Alzheimer's patients—is largely responsible for driving the disease. It is a theory that goes against much of the scientific community: For 20 years, billions of dollars of pharmaceutical investment has supported a different theory that places chief blame on a different protein, beta amyloid, which forms sticky plaques in the brains of sufferers. But a string of experimental drugs designed to attack beta amyloid have failed recently in clinical trials, including two this summer from Eli Lilly LLY 0.00% & Co. and a partnership involving Pfizer Inc., PFE +0.04% Johnson & Johnson JNJ +0.32% and Elan Corp. DRX.DB +2.30%
After years on the sidelines, Dr. Wischik, who now lives in Scotland, sees this as tau's big moment. The company he co-founded 10 years ago, TauRx Pharmaceuticals Ltd., has developed an experimental Alzheimer's drug that it will begin testing in the coming weeks in two large clinical trials. Slowly, other companies are boosting investment in tau research, too. This summer, Roche Holding AG ROG.VX -0.11% bought the rights to a type of experimental tau drug from Switzerland's closely held AC Immune SA.
History is peppered with examples of scientists who struggled against a prevailing orthodoxy, only to be proved right. In 1854, British doctor John Snow traced a cholera outbreak in London to a contaminated water supply, but his discovery was rejected by other scientists, who believed bad vapors in the air caused the disease. In the 1880s, cholera was finally pegged to bacteria found in contaminated water. In 1982, when two Australian scientists declared that bacteria caused peptic ulcers, conventional wisdom had it that stress and lifestyle were to blame. The scientists won the 2005 Nobel Prize in medicine for their discovery.
It is far from clear whether Dr. Wischik will join their ranks. Although interest in tau is building, opinions about the cause of Alzheimer's remain deeply divided. Some scientists believe an interaction between beta amyloid and tau plays a central role. Others think there are many possible triggers, including some beyond beta amyloid or tau.
Dr. Wischik says he and other tau-focused scientists have been shouted down over the years by what he calls the "amyloid orthodoxy," a hard-charging group of researchers who believed passionately that beta amyloid was the chief cause of the disease. "Science is politics," he says. "And the politics of amyloid won."
Yet Dr. Wischik has also been hampered by inconclusive research. A small clinical trial of TauRx's drug in 2008 produced encouraging, but mixed, results. What's more, plenty of influential scientists still are backing the idea that beta amyloid plays a central role. Although Roche is investing in tau, Richard Scheller, head of drug research at Roche's biotech unit, Genentech, says the company still is a strong believer in beta amyloid. He thinks amyloid drugs need to be tested on Alzheimer's patients much earlier in the disease cycle in order to prove effective; Roche recently announced plans to conduct such a trial.
“Drugs tied to conventional theories on Alzheimer's causes haven't been effective.”
Meanwhile, scientists Dr. Wischik accuses of wrongly fixating on beta amyloid, such as Harvard neurologist Dennis Selkoe, say the evidence for pursuing amyloid is strong. "Claude I think sees the world somewhat darkly…if we've made our case more potently for [beta amyloid], there is nothing wrong with that," Dr. Selkoe says. He adds that he supports tau research, as well, and believes drugs to attack both beta amyloid and tau will be necessary.
Alzheimer's disease is the leading cause of dementia in the elderly, and according to the World Health Organization, the cost of caring for dementia sufferers totals about $600 billion each year world-wide. The disease was first identified in 1906 by German physician Alois Alzheimer, who studied the brain of a deceased woman who had suffered from dementia and documented the plaques and tangles that riddled the tissue. The following decades brought few advancements in understanding the disease, in part because of the difficulty of studying the human brain, which unlike other tissues cannot be biopsied and examined until after death.
Still, in the 1960s, British scientist Martin Roth and colleagues showed that the degree of clinical dementia was worse for patients with more tangles in the brain. In the 1980s, Dr. Wischik joined Dr. Roth's research group at Cambridge University as a Ph.D student, and was quickly assigned the task of determining what tangles were made of, which launched his brain-collecting mission, and years of examining tissue.
Finally, in 1988, he and colleagues at Cambridge published a paper demonstrating for the first time that the tangles first observed by Alzheimer were made at least in part of the protein tau. Later research identified tau as the main ingredient. Like all of the body's proteins, tau has a normal, helpful function—working inside neurons to help stabilize the fibers that connect nerve cells. But when it misfires, tau can clump together to form harmful tangles that kill brain cells.
Several pieces of evidence convinced an influential group of scientists that beta amyloid was the primary cause of Alzheimer's. Among these was the discovery of several genetic mutations that all but guaranteed a person would develop a hereditary type of the disease. These mutations also appeared to increase the production or accumulation of beta amyloid in the brain, leading scientists to believe that amyloid deposits were the main cause of the disease.
The so-called "amyloid hypothesis" quickly gripped the field, and attacking the protein became the main strategy for fighting Alzheimer's. Athena Neurosciences, a biotech company whose founders included Harvard's Dr. Selkoe, focused in earnest on developing drugs to attack amyloid. Meanwhile, tau researchers say they found it hard to get research funding or to publish papers in medical journals.
"It was very difficult to have a good publication on tau, because the amyloid cascade was like a dogma," says Luc Buee, a tau-focused researcher at the French National Institute of Health and Medical Research. "For 15 years if you were not working in the amyloid field you were not working on Alzheimer's disease."
Dr. Wischik and his colleagues fought to keep funding from the UK's Medical Research Council for the repository of brain tissue they maintained at Cambridge, he says. The brain bank became an important tool. In the early 1990s, Dr. Wischik and his colleagues compared the postmortem brains of Alzheimer's sufferers against those of people who had died without dementia, to see how their levels of amyloid and tau differed. They found that both healthy brains and Alzheimer's brains could be filled with amyloid plaque, but only Alzheimer's brains contained aggregated tau. What's more, as the levels of aggregated tau in a brain increased, so did the severity of dementia. "We decided that amyloid isn't what is making people demented," Dr. Wischik says.
In the mid-1990s, Dr. Wischik discovered that a drug sometimes used to treat psychosis dissolved tangles in a test tube. He tried to set up a company to develop the drug as a treatment for Alzheimer's, but found that American and British venture capitalists wanted to invest in amyloid projects, not tau.
By 2002, Dr. Wischik scraped together about $5 million from Asian investors with the help of a Singaporean physician who was the father of a classmate of Dr. Wischik's son in Cambridge. TauRx is based in Singapore but conducts most of its research in Aberdeen, Scotland.
As his tau effort launched, early tests of drugs designed to attack amyloid plaques were disappointing. A vaccine developed by Athena Neurosciences failed to improve patients' cognitive function in a trial that ended in 2002.
To better understand these results, a team of British scientists largely unaffiliated with Athena or the failed clinical trial decided to examine the brains of patients who had participated in the study. They waited for the patients to die, and then, after probing the brains, concluded that the vaccine had indeed cleared amyloid plaque but hadn't prevented further neurodegeneration.
Commitment to the amyloid hypothesis persisted, however. Peter Davies, an Alzheimer's researcher at the Feinstein Institute for Medical Research in Manhasset, NY, recalls hearing a researcher at a conference in the early 2000s concede that his amyloid research results "don't fit the hypothesis, but we'll keep going till they do."
"I just sat there with my mouth open," he recalls.
In 2004, TauRx began a clinical trial of its drug, called methylene blue, in 332 Alzheimer's patients. Around the same time, a drug maker called Elan Corp., which had bought Athena Neurosciences, began a trial of an amyloid-targeted drug called bapineuzumab in 234 patients.
A key moment came in 2008, when Dr. Wischik and Elan presented results of their studies at an Alzheimer's conference in Chicago. The Elan drug failed to improve cognition any better than a placebo pill, causing Elan shares to plummet by more than 60% over the next few days.
The TauRx results Dr. Wischik presented were more positive, though not unequivocal. The study showed that, after 50 weeks of treatment, Alzheimer's patients taking a placebo had fallen 7.8 points on a test of cognitive function, while people taking 60 mg of TauRx's drug three times a day had fallen one point—translating into an 87% reduction in the rate of decline for people taking the TauRx drug.
But TauRx didn't publish a full set of data from the trial, causing some skepticism among researchers. (Dr. Wischik says it didn't to protect the company's commercial interests). What's more, a higher, 100-mg dose of the drug didn't produce the same positive effects in patients; Dr. Wischik blames this on the way the 100-mg dose was formulated, and says the company is testing a tweaked version of the drug in its new clinical trials, which will begin enrolling patients late this year.
Meanwhile, drugs designed to attack beta amyloid have continued to disappoint. This summer, a trio of companies that now own the rights to bapineuzumab—Elan, Pfizer and Johnson & Johnson—scrapped development of the drug after it failed to work in two large clinical trials.
Then in August, Eli Lilly & Co. said its experimental medicine targeting beta amyloid, solanezumab, failed to slow the loss of memory or basic skills like bathing and dressing in two trials involving 2,050 patients with mild or moderate Alzheimer's. Just recently, Lilly disclosed that in one of the trials, when moderate patients were stripped away, the drug slowed cognitive decline only in patients with mild forms of the disease. Lilly said it would talk to regulators before deciding what to do next with the experimental drug.
The trial failures have tempered support for the amyloid hypothesis, but there are still fervent believers who say beta amyloid needs to be attacked very early in the disease cycle—perhaps before symptoms begin—for such medicines to work. This spring, the U.S. government said it would help fund a $100 million trial of Roche's amyloid-targeted drug, crenezumab, in 300 people who are genetically predisposed to develop early-onset Alzheimer's but who don't yet have symptoms. Dr. Selkoe, one of the authors of the amyloid hypothesis, says this trial should help provide a "definitive" answer about the theory.
Scientists and investors, meanwhile, are turning more attention to tau. Roche this year said it would pay Switzerland's AC Immune an undisclosed upfront fee for the rights to a new type of tau-targeted drug, and up to CHF400 million in additional payments if any drugs make it to market.
Dr. Buee, the longtime tau researcher in France, says Johnson & Johnson asked him to provide advice on tau last year, and that he's currently discussing a tau research contract with a big pharmaceutical company. (A Johnson & Johnson spokeswoman says the company invited Dr. Buee and other scientists to a meeting to discuss a range of approaches to fighting Alzheimer's.)
With its new clinical trial program under way, TauRx is the first company to test a tau-targeted drug against Alzheimer's in a large human study, known in the industry as a phase 3 trial. With his passionate beliefs, Dr. Wischik admits he may be just as much a zealot about tau as he accuses others of being about beta amyloid. "I may be," he says. "In the end…it's down to the phase 3 trial."
Write to Jeanne Whalen at jeanne.whalen@wsj.com
http://online.wsj.com/article/SB10000872396390443624204578060941988428604.html?mod=e2tw
"4 analyzers were outright sales" - this makes more sense...
$157K/4 = $39.5K per analyzer
these are probably higher volume units paying lower rate for reagents.
Pre-market I'm seeing $9.58 offered with no volume. I don't think my bid is going to get hit @ 8.08 LOL.
Wow - this is just a flat out a blow out quarter...
Revs for the first 6 mos was $5.6M... they almost equaled that this Q with $5.3M... and now they're guiding for >$7M in 4Q. Annual revs/workstation jumped from $48K in 1Q to $73K in 2Q to $93K in 3Q....impressive.
CC tomorrow..
GenMark Diagnostics Third Quarter Earnings Conference Call
Nov 8, 2012 at 9:00 AM ET
http://ir.genmarkdx.com/eventdetail.cfm?eventid=120862
GenMark Diagnostics Reports Third Quarter 2012 Results
Quarterly Reagent Revenue Grows 339%
Installed Base Grows to 255 Analyzers
Quarterly Gross Margin Reaches 42%
Annuity Per Analyzer Increased to $93,000
FY 2012 Revenue Guidance Raised to > $18 million
November 7, 2012
CARLSBAD, Calif.--(BUSINESS WIRE)-- GenMark Diagnostics, Inc. (Nasdaq:GNMK), a leading provider of automated, multiplex molecular diagnostic testing systems, today reported financial results for the third quarter ended September 30, 2012.
Revenues for the quarter ending September 30, 2012 were $5.3 million compared with $1.3 million during the third quarter of 2011. The 299% year-over-year increase in total revenue reflects an increase in the number of systems placed at customer sites and a significant increase in the number of tests sold, including as a result of test menu expansion. Reagent revenues for the third quarter grew 339% year-over-year to $5.1 million from $1.1 million. Instrument and other revenues increased by 1% year-over-year to $157,000 from $156,000 due mainly to capital sales of instruments.
The Company placed a net 35 analyzers during the quarter, bringing the total installed base to 255. All of the Company's 255 analyzers have been placed with end-user laboratories within the U.S. market.
Gross profit for the quarter ending September 30, 2012 was $2.2 million, or 42% of revenue, compared with a gross loss of $469,000, or (36%) of revenue for the same period in 2011. The continued improvement in gross profit is the result of significant sales volume increases and manufacturing efficiencies.
Operating expenses increased $2.8 million to $8.5 million during the third quarter of 2012 compared with the third quarter of 2011. Selling, General and Administrative expenses increased $262,000 year-over-year due to the increase in revenue, headcount growth and other corporate expenses. Research and Development expenses increased $2.6 million due to an expansion of the R&D team, menu development for the XT-8 and initial development work on the NexGen platform.
Loss per share was $0.20 for the third quarter of 2012, compared with a loss per share of $0.31 in the third quarter of 2011.
"Our Commercial team delivered another strong quarter. We expanded our installed base to 255 by placing 35 new analyzers in the field. We also significantly grew our reagents business in the third quarter by adding new customers, as well as expanding menu utilization and revenue with existing customers," stated GenMark's President & CEO Hany Massarany. "Furthermore, we accomplished several key product development goals in the quarter, including launching our FDA cleared RVP Test, as well as successfully showing a prototype of our NexGen sample-to-answer system at the Association for Molecular Pathology (AMP) meeting at the end of October."
The Company ended the third quarter of 2012 with $57.0 million in cash, cash equivalents and restricted cash. The Company intends to continue utilizing its cash balances to invest in new product and menu development, including the development of its NexGen platform, and for infrastructure improvements and general corporate purposes.
More Davunetide comments...
FWIW...
Rodman & Renshaw presentation...
http://www.wsw.com/webcast/rrshq22/npc.cn/
Novadaq Reports Third Quarter 2012 Financial Results
Press Release: Novadaq Technologies Inc.
TORONTO, ONTARIO--(Marketwire - Nov 2, 2012) - Novadaq® Technologies Inc. ("Novadaq" or the "Company") (NDQ.TO)(NVDQ), a developer of clinically-relevant fluorescence imaging solutions for use in surgical procedures, today announced financial results for its third quarter ended September 30, 2012. Unless otherwise indicated, all dollar amounts in this press release are expressed in United States (U.S.) dollars.
Novadaq reported total third quarter 2012 revenue of $6.0 million, representing an increase of 39% as compared to third quarter of 2011. Revenue growth was driven by continued adoption of SPY Elite® and FIREFLY™ procedures and higher SPY Elite and FIREFLY system sales to end users.
Third quarter of 2012 recurring revenue for Novadaq''s SPY businesses increased by 99% year-over-year to $2.9 million, and increased 16% sequentially from $2.5 million in the second quarter of 2012.
Third quarter of 2012 operating contribution (cash contributed by operating activities before changes in working capital) was $0.1 million compared with an operating burn of $0.4 million in the third quarter of 2011. During the third quarter, working capital contributed $0.2 million, and $0.8 million was invested in fixed assets, including $0.7 million to build the SPY Elite installed base.
Net loss of $9.3 million for the third quarter of 2012 increased by $8.0 million compared with the $1.3 million net loss in third quarter 2011. Third quarter of 2012 loss per share was $0.23. Excluding the impact of a non-cash $8.0 million warrants revaluation expense in third quarter 2012, loss per share was $0.03, compared with $0.05 in third quarter 2011.
Cash and cash equivalents were $41.2 million at September 30, 2012, reflecting a decrease of $0.5 million, compared to the cash position as of June 30, 2012.
Novadaq shipped 108 imaging systems and approximately 4,600 SPY Elite and FIREFLY procedures kits during the third quarter of 2012. The combined installed base of SPY technology in the United States now exceeds 600 systems.
"We continue to see evidence that SPY technology is being embraced by surgeons across multiple specialties", commented Dr. Arun Menawat, Novadaq''s President and CEO. "Recruitment into the PILLAR™ multi-center clinical study in patients undergoing low anterior colon resection surgery using our new product, PINPOINT®, is progressing at seven participating sites."
Conference Call
Novadaq is pleased to invite all interested parties to participate in a conference call today, Friday, November 2, 2012, at 8:30 a.m. Eastern Time during which the results will be discussed.
Those wishing to access the live conference call by telephone should dial 1-877-407-8031 (within Canada and the United States) or 1-201-689-8031 (international callers) several minutes prior to the beginning of the call. A telephonic replay of the conference call will be made available until midnight on December 2, 2012 and can be accessed by dialing 1-877-660-6853 (within Canada and the United States) or 1-201-612-7415 (international callers) and entering the conference identification number 402238 when prompted.
The call will be archived for 90 days on the Company''s website at www.novadaq.com under the "Events" tab in the Investors section. In addition, a replay of the call will be available for download to a portable audio player or computer, as an MP3 or podcast file, at the same location on Novadaq''s website.
Cellular Therapy Wave Finally Cresting
With Over $900 Million in Revenues Expected in 2012, Field Is on a Roll
http://www.genengnews.com/gen-articles/cellular-therapy-wave-finally-cresting/4582/
snips...
There are over 15 cell therapy products commercially distributed by companies in the U.S. including: Dermagraft, Osteocel, PureGen, BioDfactor, BioDfence, Provenge, Carticel, Epicel, Nucel, Appligraf, GINTUIT, Trinity, Grafix, DeNovoET, Prokera, and AmnioGraft.
The cell therapy products distributed in the U.S. and Europe in total are expected to generate approximately $900M in revenues in 2012. Removing Provenge revenue, the bona fide stem cell sector is expected to generate in the range of $550M in 2012. Despite the relative small size of the sector, it is trending in the right direction as this is twice what the sector is estimated to have generated in 2010.
While no cell therapy products received regulatory approval between 2001 and 2009, the sector has had 8 such approvals in the past 36 months.
AMP abstracts on Thrombo, HVC, RVP etc… eSensor vs. Siemens, Roche, Luminex, Idaho… all positive...
Download here...search on "Genmark" ...
http://download.journals.elsevierhealth.com/pdfs/journals/1525-1578/PIIS1525157812002115.pdf
theflyonthewall.com: Novadaq Technologies price target raised to $17 from $9 at Needham
Needham increased its target on Novadaq as the firm believes it was previously underestimating the sales potential of the company's Pinpoint and Luna products. The firm maintains a Buy rating on the shares.
Neuraltus Pharmaceuticals Announces Phase 2 Clinical Results for NP001 in Patients with Amyotrophic Lateral Sclerosis (ALS)
Based on the study's positive efficacy trends and discussions with the U.S. Food & Drug Administration (FDA), Neuraltus plans Phase 3 clinical program to commence in the 2nd half of 2013
By Neuraltus Pharmaceuticals
Published: Tuesday, Oct. 30, 2012 - 4:39 am
PALO ALTO, Calif., Oct. 30, 2012 -- /PRNewswire/ -- Neuraltus Pharmaceuticals, a private biopharmaceutical company developing novel therapies for rare neurological disorders, announced today top-line results from the Company's Phase 2 clinical study of NP001 in patients with Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig's disease). Study efficacy results demonstrated positive trends in slowing the rate of disease progression, ranging from 13 to 19% in multiple parameters of clinical benefit, although these pre-defined endpoints did not reach statistical significance. Importantly, according to a post hoc analysis, a greater percentage of patients receiving NP001 experienced a halt in disease progression which reached statistical significance when compared to the combination of concurrent and matched historical (placebo) controls. Further, NP001 was found to be safe and well-tolerated. Based on these results, and after a meeting with the FDA, Neuraltus is planning a Phase 3 clinical program that is expected to begin in the second half of 2013.
"ALS is a rare neurodegenerative disease that typically leads to respiratory failure and death within five years of diagnosis. The results from this study with NP001 are most encouraging, as halting or slowing the rate of disease progression, in a subset of patients, as this study suggests, would translate into a clear clinical benefit for these patients," commented Robert G. Miller, M.D., of California Pacific Medical Center, the Principal Investigator of the study.
NP001 is a small molecule regulator of macrophage activation. Aberrant macrophage activation is believed to be a significant contributor to the pathology underlying ALS and other neurodegenerative diseases. Neuraltus' NP001 is designed to restore the normal functioning of macrophages within the central nervous system.
The multi-center, double-blind, placebo-controlled, Phase 2 study enrolled 136 patients with ALS. Patients were randomized to receive either placebo, or 1mg/kg or 2mg/kg intravenous infusion of NP001 over a period of six months, followed by a six-month follow-up period. The study was designed to evaluate the change in slope of the ALS Functional Rating Score Revised (ALSFRS-R) and the safety and tolerability of NP001, as well as change from baseline in ALSFRS-R through six months, a joint rank analysis of change of ALSFRS-R adjusted for mortality and changes in readily measured peripheral inflammation biomarkers. An additional secondary endpoint agreed upon with the FDA was the inclusion of matched historical placebo control ALS patients to increase signal detection and power.
Post hoc analysis of the Phase 2 study showed a dose response to NP001 with 27% of the patients who received 2mg/kg NP001 having no progression of their disease during the six-month dosing period. This is approximately 2.5 times as many as were seen in the concurrent placebo group. When historical placebo controls were included with concurrent controls, this difference versus placebo became statistically significant. Although post hoc analysis must be considered cautiously and can be subject to bias, the magnitude of the benefit identified underscores a potentially clinically relevant and meaningful result. In addition, results from the study demonstrated trends of clinical benefit for the 2 mg/kg cohort in the primary endpoint of change in slope of the ALSFRS-R, and in the secondary endpoints of change from baseline in ALSFRS-R through six months and a joint rank analysis of change of ALSFRS-R adjusted for mortality.
Neuraltus has established a toll-free number for patients and physicians to answer questions about the study. That number, 1-888-347-7799, will be available through December 31, 2012.
About Neuraltus Pharmaceuticals, Inc. Neuraltus Pharmaceuticals, Inc. is a privately held biopharmaceutical company developing novel, first-in-class therapeutics that address critical unmet needs in the treatment of rare neurological disorders. In addition to NP001, Neuraltus also has a pre-clinical program, NP003, for the treatment of lysosomal storage disorders such as Fabry's disease and Gaucher's disease. For more information on Neuraltus, please visit www.neuraltus.com.
Read more here: http://www.sacbee.com/2012/10/30/4947981/neuraltus-pharmaceuticals-announces.html#storylink=cpy
Celldex Therapeutics makes 'significant advancements' in the field of protein-based vaccine development; CDX-1401 is well-tolerated and elicits robust antibody and T cell responses in patients with cancer (5.47)
Co announced positive results demonstrating promising clinical effects in a Phase 1 study of CDX-1401 in solid tumors in combination with the toll-like receptor (TLR) agonists resiquimod and/or Poly ICLC (HiltonolTM). CDX-1401 is a fusion protein consisting of a fully human monoclonal antibody with specificity for the dendritic cell receptor DEC-205 linked to the NY-ESO-1 tumor antigen. The NY-ESO-1 antigen is expressed in a variety of cancer cells. Targeting protein antigens to the DEC-205 receptor on dendritic cells was pioneered by the late Ralph Steinman, MD, a member of Celldex's Scientific Advisory Board. Dr. Steinman received the 2011 Nobel Prize in Physiology or Medicine for his discovery of the dendritic cell and its role in adaptive immunity. In preclinical studies, CDX-1401 has been shown to induce potent and broad immunity. The Phase 1 study of CDX-1401 is the first clinical study to demonstrate that an off-the-shelf vaccine that targets dendritic cells in vivo through DEC-205 can safely lead to robust humoral and cellular immunity when combined with TLR agonists in cancer patients - overcoming a significant challenge in the development of protein based vaccines.
Read more: http://www.briefing.com/InPlayEq/InPlay/InPlayDual.htm#ixzz2AgwxEHpl
Ex-Geron Corporation (GERN) CEO Launches Effort to Revive Lost Stem Cell Program
10/25/2012 9:07:17 AM
The world's largest embryonic stem cell research programme could be given a new lease of life. In 2011, biotech giant Geron announced that it was closing its stem cell programme, even though it had conducted a decade of research and treated four people in the first clinical trial of human embryonic stem cells (hESCs). Now, Geron's former chief executive Thomas Okarma, and founder Michael West, have joined forces with a new subsidiary of BioTime, a biotech company based in Alameda, California. Together they have put forward a bid for Geron's stem cell assets in an effort to revive the programme. Meanwhile, the four volunteers that received hESCs for spinal injuries are being monitored for adverse effects by the California Institute for Regenerative Medicine in San Francisco.
http://www.clinicaspace.com/news_story.aspx?NewsEntityId=277243&type=email&source=CS_102512
BB... I copied the last 2 posts over to the NVDQ board. Continue discussion there.
Continued from GNMK board...
BB - I have the same reservations re Pinpoint but they are already in > 400 hospitals through their partners. They should be able to tag team with the ISRG and Lifecell reps to make contact with decision-makers. It shouldn't be that difficult to get the attention of hospital admin with Firefly outcomes documented and hospital docs providing testimonials. PILLAR data should be ready by April 2013... that should provide the cost/payback timeline and give the reps some ammo.
From NVDQ's JMP conference presentation...
"In colorectal procedures early data shows reduction of necrosis from 15-25% down to 3-4% "
Not sure what percentage of readmissions are due to necrosis but colorectal seems to have a higher readmission rate than most....
HOSPITAL READMISSIONS AFTER COLON SURGERY COMMON, COSTLY - AND PREVENTABLE
Release Date: 11/16/2011
Johns Hopkins researchers find nearly one in four patients readmitted within 90 days at a cost of $300 million a year
http://www.hopkinsmedicine.org/news/media/releases/hospital_readmissions_after_colon_surgery_common_costly___and_preventable
Hi BB... everything you outlined is also why I'm attracted to this company. If you get a chance have a look at another medical device razor/blade stock...Novadaq - NVDQ. GNMK is my 2nd largest holding after NVDQ. NVDQ is on the same growth curve and also unfollowed. They have an imaging system (razor) for prostatectomy, breast reconstruction, colorectal, nephrectomy and other surgeries where a fluorescent dye (razor blade)is injected then the tissue is lit up with an infrared laser endoscope. The surgeon is able to see perfusion thus avoiding complications from suturing dead tissue. They have other imaging agents in development to light up tumors, nerves and lymph nodes. Eventually surgeons will be able to make one injection and each tissue type will light up a different color... it will become the standard for the OR... the holy grail. Well that's the plan anyway... as always, execution is the key . So far they have been executing. They already have partnerships with Intuitive Surgical, Maquet and KCI-Lifecell.
GenMark to Show its All-Electronic, Sample-to-Answer Molecular Diagnostics Platform at the Association for Molecular Patholog...
Date : 10/22/2012 @ 9:00AM
GenMark Diagnostics Inc., (NASDAQ: GNMK) a leading provider of automated, multiplex molecular diagnostic testing systems, announced today that it will show a prototype of the Company’s NexGen system, an all-electronic fully integrated molecular diagnostics platform, at the Association of Molecular Pathology (AMP) meeting to be held on October 25-27, 2012 in Long Beach, California.
The NexGen platform is a multiplex sample-to-answer system which integrates sample preparation steps including extraction and amplification, together with the company’s proprietary electrochemical detection technology, to enable concurrent detection of multiple molecular targets on a single test cartridge. All necessary reagents are fully incorporated in self-contained test cartridges, with the required fluidic movement enabled by proprietary digital microfluidics technology licensed by the Company earlier this year.
GenMark is also developing an extensive test menu for the NexGen platform which covers a broad range of disease states. With an initial focus on infectious disease, the Company will target both multiplex and less complex test panels where current platform and menu options are very limited. Future NexGen menu will also include test panels for pharmacogenetic, oncology and genetic testing.
“The demonstration of our prototype NexGen system at AMP is a significant milestone which highlights the continued progress of our product development program and supports our goal of commercial launch in late 2013,” commented Hany Massarany, President and CEO of GenMark Diagnostics. “The revolutionary and proprietary combination of electronic detection and digital microfluidics underpins the unique value proposition of our all-digital sample-to-answer NexGen system; a system we believe will redefine industry standards for performance, reliability and ease of use even with the most complex assays.”
For more information regarding the AMP showing of the GenMark NexGen platform, investors should contact GenMark Diagnostics at (760) 448-4358.
Statement from ZIOP...
Ziopharm Oncology issues statement regarding misleading blog; states 'statements made in Mr. Pearson's blog entry are misleading and wrong' (4.29 -0.33)
Co issued the following statement regarding a blog entry posted by Richard Pearson, Contributor, on Forbes.com: "The statements made in Mr. Pearson's blog entry are misleading and wrong and, given his disclosed investment position, we call into question the entire credibility of this piece. The Form 483 was issued directly to the independent investigator, not to ZIOPHARM, and had nothing to do with any outcome measures of the Phase 2 PICASSO study. All regulatory matters raised in Mr. Pearson's blog entry were resolved by the investigator in full in 2010, and had no impact on the Company's transition from Phase 2 to Phase 3. Further, the Company has no issues with drug stability. We stand by the clinical data generated at this investigator's site. Consistent with best practices, all data from ZIOPHARM's Phase 2 PICASSO study at this site were reviewed by an independent, former FDA good clinical practice auditor, and the auditor concluded that the study site's violations had no impact on the PICASSO study or the quality of data."
Read more: http://www.briefing.com/InPlayEq/InPlay/InPlayDual.htm#ixzz29m24f5xv
NVDQ earnings... Nov 2
TORONTO, ONTARIO -- (Marketwire) -- 10/19/12 -- Novadaq®Technologies Inc. ("Novadaq" or the "Company") (TSX:NDQ)(NASDAQ:NVDQ), a developer of real-time medical imaging systems for use in the operating room, will announce its third quarter 2012 financial results before the market opening on Friday, November 2, 2012.
Novadaq is pleased to invite all interested parties to participate in a conference call, on November 2 at 8:30 a.m. Eastern Time, during which the results will be discussed.
Those wishing to access the live conference call by telephone should dial 1-877-407-8031 (within Canada and the United States) or 1-201-689-8031 (international callers) several minutes prior to the beginning of the call. A telephonic replay of the conference call will be made available until midnight on December 2, 2012 and can be accessed by dialing 1-877-660-6853 (within Canada and the United States) or 1-201-612-7415 (international callers) and entering the conference identification number 402238 when prompted.
The call will be archived for 90 days on the Company's website at http://www.novadaq.com under the "Events" tab in the Investors section. In addition, a replay of the call will be available for download to a portable audio player or computer, as an MP3 or podcast file, at the same location on Novadaq's website.
Upon the completion of the OURLab acquisition, Dr. Jonathan Oppenheimer, OURLab's founder and Chief Executive Officer, will assume the role of Chief Executive Officer of OPKO's diagnostics division. "OURLab anticipates that OPKO's superior resources and novel technologies will facilitate greater penetration into other medical subspecialties and give its sales force unique products to serve its growing physician and laboratory clientele. The 4Kscore™ is a prime example of a timely medical test satisfying a clear unmet need," commented Dr. Oppenheimer.
18 sites...
OPKO Health (OPK) has entered into a definitive agreement to acquire Prost-Data, doing business as OURLab, a Nashville-based CLIA laboratory with 18 phlebotomy sites throughout the U.S. and an experienced national sales force calling primarily on urologists.
Read more: http://www.briefing.com/InPlayEq/InPlay/InPlayDual.htm#ixzz29kqDuM2u
Novadaq Tech. initiated with a Buy at Canaccord Genuity (11.46)
As mentioned earlier Canaccord Genuity initiated NVDQ with a Buy and price target of $15 saying the co possesses a unique technology that they believe could become a standard-of-care intra-operative imaging modality across multiple open and minimally-invasive surgical applications. They think the most appropriate relative comparisons to use to value NVDQ are other high- growth med-tech companies whose technologies possess similar attributes -- i.e., established or emerging standard of care, addresses nascent growth markets, and is improving outcomes for patients.
Read more: http://www.briefing.com/InPlayEq/InPlay/InPlayDual.htm#ixzz29kohdFej
Novadaq Tech. initiated with a Buy at Canaccord Genuity (11.46)
Novadaq Tech.: Initiation details (11.46)
As mentioned earlier Canaccord Genuity initiated NVDQ with a Buy and price target of $15 saying the co possesses a unique technology that they believe could become a standard-of-care intra-operative imaging modality across multiple open and minimally-invasive surgical applications. They think the most appropriate relative comparisons to use to value NVDQ are other high- growth med-tech companies whose technologies possess similar attributes -- i.e., established or emerging standard of care, addresses nascent growth markets, and is improving outcomes for patients.
Read more: http://www.briefing.com/InPlayEq/InPlay/InPlayDual.htm#ixzz29kaG5ta1
Lots of insider selling... now a $ 150M shelf. Does anyone know their latest cash position and their burn rate?
Glad I held off on this. I'll get in after the raise.
From ISRG's CC...Novadaq's Firefly was installed on 64 DaVinci systems in 3Q... NVDQ's Firefly, SPY and PINPOINT could become standard in the OR for many types of surgery...
“Before the start of a surgery, imagine a patient being painlessly injected with multiple imaging molecules, each of which will go to its own sweet spot, to light up nerves in one color, perfusion of blood vessels in another color and cancer cells in yet a third color,” he adds.
“This would serve as a physiologically and anatomically enriched roadmap for a surgeon, who could then provide specific treatments for all of the disease processes afflicting a patient with the added confidence of image guidance. It would be like a GPS system inside a patient, telling a surgeon where to go and where not to go. This would be a game changer for surgery.”
NVDQ has partnerships with KCI/Lifecell and Maquet as well...
http://biotuesdays.com/2012/10/16/novadaq-highlights-game-changer-for-the-or/
"game changer for surgery"
“Before the start of a surgery, imagine a patient being painlessly injected with multiple imaging molecules, each of which will go to its own sweet spot, to light up nerves in one color, perfusion of blood vessels in another color and cancer cells in yet a third color,” he adds.
“This would serve as a physiologically and anatomically enriched roadmap for a surgeon, who could then provide specific treatments for all of the disease processes afflicting a patient with the added confidence of image guidance. It would be like a GPS system inside a patient, telling a surgeon where to go and where not to go. This would be a game changer for surgery.”
BioTuesdays article... Novadaq Highlights Game Changer For The OR
http://biotuesdays.com/2012/10/16/novadaq-highlights-game-changer-for-the-or/
NREL nanotechnology solar cell achieves 18.2% efficiency
Mon, 10/15/2012 - 8:18am
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Scientists at the U.S. Department of Energy (DOE)'s National Renewable Energy Laboratory (NREL) have produced solar cells using nanotechnology techniques at an efficiency—18.2%—that is competitive. The breakthrough should be a major step toward helping lower the cost of solar energy.
NREL tailored a nanostructured surface while ensuring that the light-generated electricity can still be collected efficiently from the solar cell. The researchers made nanoislands of silver on a silicon wafer and immersed it briefly in liquids to make billions of nano-sized holes in each square-inch of the silicon wafer surface. The holes and silicon walls are smaller than the light wavelengths hitting them, so the light doesn't recognize any sudden change in density at the surface and, thus, don’t reflect back into the atmosphere as wasted energy. The researchers controlled the nanoshapes and the chemical composition of the surface to reach record solar cell efficiencies for this ‘black silicon’ material.
The paper, "An 18.2%-efficient black-silicon solar cell achieved through control of carrier recombination in nanostructures" by NREL's Jihun Oh, Hao-Chih Yuan, and Howard Branz, appears online in Nature Nanotechnology.
Typically, solar cell manufacturers must add an extra anti-reflection layer, or two, to their cells, which boosts costs significantly.
NREL previously had demonstrated that their nanostructures reflected less light than the best anti-reflection layers of a solar cell. But until now, they hadn't been able to achieve overall efficiency with their black silicon cells that could approach the best marks for other silicon cells.
Oh, Yuan, and Branz, first had to determine why the increased surface area of the nanostructures dramatically reduced the collection of electricity and hurt the voltage and current of the cells.
Their experiments demonstrated that the high-surface area, and especially a process called Auger recombination, limit the collection of photons on most nanostructured solar cells. They concluded that this Auger recombination is caused when too many of the dopant impurities put in to make the cell work come through the nanostructured surface.
This scientific understanding enabled them to suppress Auger recombination with lighter and shallower doping. Combining this lighter doping with slightly smoother nanoshapes, they can build an 18.2%-efficient solar cell that is black but responds nearly ideally to almost the entire solar spectrum.
The Energy Department funded the research grant through the American Recovery and Reinvestment Act.
Branz, the grant's principal investigator, says, "This work can have a big impact on both conventional and emerging solar cell based on nanowires and nanospheres. For the first time it shows that really great solar cells can be made from nanostructured semiconductors."
Branz adds, "The next challenges are to translate these results to common industrial practice and then get the efficiency over 20%. After that, I hope to see these kinds of nanostructuring techniques used on far thinner cells to use less semiconductor material."
"Now we have a clear study that shows how optimizing the surface area and the doping together can give better efficiency,” Yuan says. “The surface area and the doping concentration near the surface affect nano-structured solar-cell performance."
First author, Oh, an NREL Postdoctoral Fellow said the NREL study "clearly shows that the right combination of a carefully nano-structured surface and good processing can reduce the cost while cutting unwanted reflection of sunlight."
Source: National Renewable Energy Laboratory
ACE + ARB works best according to this...
Boston, MA - A new study shows a significant reduction in the incidence of Alzheimer's disease and dementia among subjects taking angiotensin-receptor blockers (ARBs), compared with those taking ACE inhibitors or other cardiovascular drugs [1].
Further, there appeared to be a reduction in rates of disease progression, indicated by the time to admission to a nursing home or death, among those taking ARBs, the authors note.
"We also saw that the people who did the best appeared to be those who were taking ARBs together with ACE inhibitors," said senior author Dr Benjamin Wolozin (Boston University School of Medicine, MA).
"There, the data actually get very striking; we saw a 55% lower incidence of Alzheimer's [disease] or dementia, and a 70% decrease in nursing-home admissions," Wolozin added.
Their report was published online January 12, 2010 in BMJ.
www.theheart.org/article/1043019.do
Spencer Nam, ThinkEquity, LLC (10/9/12) "We reiterate our Buy rating and $640 price target on Intuitive Surgical Inc. ahead of the Q3/12 report on Tuesday, October 16th, after the market close; we expect Intuitive Surgical to exceed consensus revenues of $535.5M (Think: $536.8M) due to strength from systems placement. . . a check with a da Vinci key opinion leader (KOL) suggests to us that new technology upgrades are keeping the interest level on da Vinci high among surgeons and hospitals. . .we expect ~26% procedure volume growth."
Bio Investor Forum presentation...
http://www.veracast.com/webcasts/bio/investorforum2012/67204389.cfm