Source the-scientist.com

A two-year battle between the US Patent and Trademark Office (USPTO) and biopharma over a much-contested set of patent rules ended yesterday (October 8) when the USPTO rescinded the rules altogether.

"These regulations have been highly unpopular from the outset and were not well received by the applicant community," said David Kappos, director of the USPTO, in a statement. "In taking the actions we are announcing [October 8], we hope to engage the applicant community more effectively on improvements that will help make the USPTO more efficient, responsive, and transparent to the public."

Source TheScientist.com Image - Doriano Solinas

A once-rare type of clinical trial that violates one of the sacred tenets of trial design is taking off, but is it worth the risk?

When researchers at Pfizer first began a Phase 2 trial of an acute stroke therapy in 2000, they decided to take a novel approach. The study—called the ASTIN trial—would determine the drug’s optimal dose not with three or four different dosing arms, as trials often have, but with 15. Data from the trial would be captured continuously and used to make changes in real time to how the trial was run. As new patients joined, they would be randomized to a particular arm based on those real-time results—a process which required an intensive level of relatively novel statistics.

Source: ChronicPainConnection.com

The highly respected ME/CFS researcher Dr. Kenny De Meirleir and his research team announced that they have uncovered a major cause of this mysterious illness as well as a diagnostic test for it.

Source: Scienceblog.com

Source Jef Akst the-scientist.com (Image: Wikimedia commons)

Researchers report a step forward in understanding the pathology of Alzheimer's disease. Two genes that are commonly mutated in the early-onset form of Alzheimer's may cause the disorder by altering how presynaptic neurons release neurotransmitters, according to a study published this week in Nature.

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Findings from the Cardiovascular Health Study-Cognition Substudy suggest that angiotensin-converting enzyme (ACE) inhibitors that cross the blood-brain barrier reduce the risk of incident dementia. Conversely, non-centrally active ACE inhibitors appear to increase the risk, relative to other antihypertensive drugs, investigators report in the Archives of Internal Medicine for July 13.

According to lead author Dr. Kaycee M. Sink from Wake Forest University Medical Center in Winston-Salem, North Carolina, and her associates, previous research comparing neuroprotective properties of different antihypertensives has yielded conflicting results.

REVIEW IN ONCOLOGY

During the week of July 12, 2009 (from July 12, 2009 to July 18, 2009) significant news items pertaining to the oncology sector were reported including:

1. Oncolytics Biotech (ONCY, Market Outperform) presented data demonstrating the synergy of reovirus in combination with temozolomide and radiation for the treatment of glioma xenografts at the 28th American Society for Virology Annual Meeting and separately published research on the synergy of reovirus and chemotherapy for the treatment of non-small cell lung cancer (NSCLC);

2. Genta (GETA.OB, Market Perform) reported publication of a paper that independently confirms the link of a key biomarker, a tumor-derived enzyme known as lactate dehydrogenase (LDH), to overall survival in patients with advanced melanoma;

This video describes a publication which used the experimental allergic encephalomyelitis model of multiple sclerosis to test immunological effects of lithium. The authors demonstrated profound inhibition of disease, as well as stimulation of antiinflammatory cytokines. It seemed like the anti-inflammatory effects of lithium were associated with the inhibition of the enzyme GSK-3.

Other treatments for multiple sclerosis that are experimental include fat stem cells, erythropoietin, and bone marrow stem cells.

By Michael Purdy, Insciences.com

A recently identified gene allows immune cells to start the self-destructive processes thought to underlie autoimmune diseases such as multiple sclerosis (MS) and rheumatoid arthritis, researchers at Washington University School of Medicine have found.

Researchers showed that mice without the Batf gene lacked a type of inflammatory immune cell and were resistant to a procedure that normally induces an autoimmune condition similar to human MS. They plan to look for other genes and proteins influenced by Batf that could be targets for new treatments for autoimmune diseases.

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It has the makings of a science fiction movie;

But this research is real.

Scientists are creating a microchip allowing humans to control computers and robots using just the power of thought.

Doctor Jo has a look at how it works.

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In a prospective, randomized trial, a single daily tablet containing efavirenz, emtricitabine, and tenofovir (Atripla; Bristol Myers Squibb & Gilead Sciences LLC) maintained viral suppression in HIV-1 infected patients as well as the standard multiple-pill regimen.

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Oral vaccine delivery using H. pylori

A network of altered genes appears to play a key role in the pathogenesis of gliomas, according to a report in the Journal of the American Medical Association for July 15.

The results of another study in the same issue show that monosomy of chromosome 10 is associated with dysregulation of epidermal growth factor signaling in glioblastomas.

In analyzing the genomic and clinical profiles of 501 patients with gliomas, Dr. Markus Bredel, from Northwestern University Feinberg School of Medicine, Chicago, and colleagues found that these brain tumors often have mutations associated with a non-random distinct genetic landscape during formation; and these mutations are linked with patient prognosis.

Source: Insciences.com

Johns Hopkins researchers have discovered a novel protein that can protect brain cells by interrupting a naturally occurring “stress cascade” resulting in cell death.

Reporting in the July 16 issue of the journal Neuron, the scientists say drugs mimicking the protein, nicknamed GOSPEL, have the potential to protect brain cells against a range of neurodegenerative conditions, including stroke and Alzheimer’s and Huntington’s diseases.

Mammalian intestinal epithelium is one of the most swiftly self-renewing tissues in the body, turning over completely every 3 to 5 days. Because of the absence of reliable stem cell markers, however, researchers have argued for decades about the identity and location of the stem cells that fuel this growth capacity.

In the intestinal epithelium, cells proliferate in glandular pockets termed the crypts of Lieberkühn. In the 1970s, two competing theories emerged for where in the crypt these all-important, self-renewing cells abide. The predominant idea, put forth by Chris Potten at the Paterson Institute for Cancer Research in Manchester, United Kingdom, and a cofounder of Epistem, an epithelial stem cell company, placed the stem cells in a location about halfway up the crypt (termed position +4).¹ Lesser known work from the McGill University lab of Charles Philippe Leblond, who died in 2007, proposed that crypt base columnar (CBC) cells, at the very base of the crypt, were the intestinal stem cells.²

Source: The-Scientist.com

Two researchers conducting animal studies on immunosuppression lied about experimental methodologies and falsified data in 16 papers and several grants produced over the past 8 years, according to the Office of Research Integrity (ORI).

The scientists, Judith Thomas and Juan Contreras, formerly at the University of Alabama at Birmingham (UAB), falsely reported that they performed double kidney removals on several rhesus macaques in experiments designed to test the effectiveness of two immune suppressing drugs -- Immunotoxin FN18-CRM9 and 15-deoxyspergualin (15-DSG) -- in preventing rejection of the a single transplanted kidney.

Robert McWilliams, M.D., a Mayo Clinic medical oncologist and Gloria Petersen, PhD, a Mayo Clinic epidemiologist, published an editorial in the June 24 issue of Journal of the American Medical Association (JAMA). The editorial commented on a study published in the same issue conducted by Donghui Li, PhD, University of Texas M. D. Anderson Cancer Center and others about the association between pancreatic cancer risk and obesity.

Dr. McWilliams briefly describes their commentary .

Source: Mayoclinic.org

Chemical dependency and recovery in patients and physicians are closely examined in a series of articles and editorials in the July 2009 issue of Mayo Clinic Proceedings. The subject is especially timely. As the immense challenges, including potential tragedies, of prescription chemical addiction and abuse are being discussed, these articles offer crucial overview, direction and optimism.

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Oral vaccine delivery using H. pylori

Barry Marshall, MD, AC, FRS, FAA, discusses the possibilities of making a swine flu vaccine using helicobacter as a vaccine delivery platform and the progress made so far by his company Ondek.

Summary:
Ondek laboratories are producing a swine flu vaccine that uses live attenuated helicobacter as a vaccine delivery platform. The vaccine is in the form of a drink and is a quick way of making large amounts of vaccine at a low price.

The Channel Group, LLC, announced that it has formed BioMed Transition Partners to assist the Boards of Directors of biomedical companies meet their fiduciary responsibilities to stabilize and realize shareholder value during this period of economic retrenchment.

By Jeremy Laurance, Health Editor, Independent.co.u

Breakthrough offers hope of finding cure for male infertility

Scientists have created human sperm in the laboratory for the first time. The extraordinary development, which until a few years ago belonged in the realms of science fiction, raises hopes that infertile men may one day be able to father their own biological children.

The sperm were created in a test tube, from stem cells derived from a five-day-old male embryo. The advance raises ethical questions over the safety of the procedure and the threat it poses to the future role of men. It was also challenged by experts who claimed the sperm-like cells produced in the experiment were not genuine sperm.

If the finding is confirmed, a single male embryo could, in theory, yield a stem-cell line which when stored could provide an unlimited supply of sperm. Once the stem-cell line was established, there would be no further reproductive need for men. In a briefing on the research, the scientists at Newcastle University and the NorthEast England Stem Cell Institute, led by Professor Karim Nayernia, raise the question of whether their discovery means "the end of men".