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To: idos who wrote (6940)7/7/2011 5:30:18 PM
From: BulbaMan   of 7044
 
The salt dogma was discredited in the late 1990s by Gary Taubes & others. Nonetheless, it’s still around and unfortunately will likely survive the latest research findings.
And what’s true for salt seems doubly true for fat. Here are links to Taubes 1998 & 2001 Science mag articles on salt & fat:
sciencemag.org 
sciencemag.org 
Peace & good health,
Bulba

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From: tnsaf7/18/2011 1:50:17 AM
   of 7044
 
OT

An Alarming New Stimulant, Legal in Many States

nytimes.com 

Dr. Jeffrey J. Narmi could not believe what he was seeing this spring in the emergency room at Schuylkill Medical Center in Pottsville, Pa.: people arriving so agitated, violent and psychotic that a small army of medical workers was needed to hold them down.

They had taken new stimulant drugs that people are calling “bath salts,” and sometimes even large doses of sedatives failed to quiet them.

“There were some who were admitted overnight for treatment and subsequently admitted to the psych floor upstairs,” Dr. Narmi said. “These people were completely disconnected from reality and in a very bad place.”

Similar reports are emerging from hospitals around the country, as doctors scramble to figure out the best treatment for people high on bath salts. The drugs started turning up regularly in the United States last year and have proliferated in recent months, alarming doctors, who say they have unusually dangerous and long-lasting effects.

Though they come in powder and crystal form like traditional bath salts — hence their name — they differ in one crucial way: they are used as recreational drugs. People typically snort, inject or smoke them.

Poison control centers around the country received 3,470 calls about bath salts from January through June, according to the American Association of Poison Control Centers, up from 303 in all of 2010.

“Some of these folks aren’t right for a long time,” said Karen E. Simone, director of the Northern New England Poison Center. “If you gave me a list of drugs that I wouldn’t want to touch, this would be at the top.”

At least 28 states have banned bath salts, which are typically sold for $25 to $50 per 50-milligram packet at convenience stores and head shops under names like Aura, Ivory Wave, Loco-Motion and Vanilla Sky. Most of the bans are in the South and the Midwest, where the drugs have grown quickly in popularity. But states like Maine, New Jersey and New York have also outlawed them after seeing evidence that their use was spreading.

The cases are jarring and similar to those involving PCP in the 1970s. Some of the recent incidents include a man in Indiana who climbed a roadside flagpole and jumped into traffic, a man in Pennsylvania who broke into a monastery and stabbed a priest, and a woman in West Virginia who scratched herself “to pieces” over several days because she thought there was something under her skin.

“She looked like she had been dragged through a briar bush for several miles,” said Dr. Owen M. Lander, an emergency room doctor at Ruby Memorial Hospital in Morgantown, W.Va.

Bath salts contain manmade chemicals like mephedrone and methylenedioxypyrovalerone, or MDPV, also known as substituted cathinones. Both drugs are related to khat, an organic stimulant found in Arab and East African countries that is illegal in the United States.

They are similar to so-called synthetic marijuana, which has also caused a surge in medical emergencies and been banned in a number of states. In March, the Drug Enforcement Administration used emergency powers to temporarily ban five chemicals used in synthetic marijuana, which is sold in the same types of shops as bath salts.

Shortly afterward, Senator Bob Casey, Democrat of Pennsylvania, asked the agency to enact a similar ban on the chemicals in bath salts. It has not done so, although Gary Boggs, a special agent at D.E.A. headquarters in Washington, said the agency had started looking into whether to make MDPV and mephedrone controlled Schedule I drugs like heroin and ecstasy.

Mr. Casey said in a recent interview that he was frustrated by the lack of a temporary ban. “There has to be some authority that is not being exercised,” he said. “I’m not fully convinced they can’t take action in a way that’s commensurate with the action taken at the state level.”

Senator Charles E. Schumer, Democrat of New York, introduced federal legislation in February to classify bath salts as controlled Schedule I substances, but it remains in committee. Meanwhile, the drugs remain widely available on the Internet, and experts say the state bans can be thwarted by chemists who need change only one molecule in salts to make them legal again.

And while some states with bans have seen fewer episodes involving bath salts, others where they remain fully legal, like Arizona, are starting to see a surge of cases.

Dr. Frank LoVecchio, an emergency room doctor at Banner Good Samaritan Medical Center in Phoenix, said he had to administer general anesthesia in recent weeks to bath salt users so agitated that they did not respond to large doses of sedatives.

Dr. Justin Strittmatter, an emergency room doctor at the Gulf Coast Medical Center in Panama City, Fla., said he had treated one man whose temperature had shot up to 107.5 degrees after snorting bath salts. “You could fry an egg on his forehead,” Dr. Strittmatter said.

Other doctors described dangerously elevated blood pressure and heart rates and people so agitated that their muscles started to break down, releasing chemicals that led to kidney failure.

Mark Ryan, the director of the Louisiana Poison Center, said some doctors had turned to powerful antipsychotics to calm users after sedatives failed. “If you take the worst attributes of meth, coke, PCP, LSD and ecstasy and put them together,” he said, “that’s what we’re seeing sometimes.”

Dr. Ryan added, “Some people who used it back in November or December, their family members say they’re still experiencing noticeable paranoid tendencies that they did not have prior.”

Before hitting this country, bath salts swept Britain, which banned them in April 2010. Experts say much of the supply is coming from China and India, where chemical manufacturers have less government oversight.

They are labeled “not for human consumption,” which helps them skirt the federal Analog Act, under which any substance “substantially similar” to a banned drug is deemed illegal if it is intended for consumption.

Last month, the drug agency made its first arrests involving bath salts under the Analog Act through a special task force in New York. Undercover agents bought bath salts from stores in Manhattan and Brooklyn, where clerks discussed how to ingest them and boasted that they would not show up on a drug test.

“We were sending out a message that if you’re going to sell these bath salts, it’s a violation and we will be looking at you,” said John P. Gilbride, special agent in charge of the New York field division of the D.E.A.

The authorities in Alton, Ill., are looking at the Analog Act as they prepare to file criminal charges in the death of a woman who overdosed on bath salts bought at a liquor store in April.

“We think we can prove that these folks were selling it across the counter for the purposes of humans getting high,” said Chief David Hayes of the Alton police.

Chief Hayes and other law enforcement officials said they had been shocked by how quickly bath salts turned into a major problem. “I have never seen a drug that took off as fast as this one,” Chief Hayes said. Others said some people on the drugs could not be subdued with pepper spray or even Tasers.

Chief Joseph H. Murton of the Pottsville police said the number of bath salt cases had dropped significantly since the city banned the drugs last month. But before the ban, he said, the episodes were overwhelming the police and two local hospitals.

“We had two instances in particular where they were acting out in a very violent manner and they were Tasered and it had no effect,” he said. “One was only a small female, but it took four officers to hold her down, along with two orderlies. That’s how out of control she was.”

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From: tom pope7/19/2011 3:03:10 AM
   of 7044
 
WSJ. Too late to change my low educational level, but maybe I can work on the others. Does the circularity of the bolded para raise questions for anybody?

Lifestyle Changes Can Reduce Risk of Alzheimer's
By SHIRLEY S. WANG

Paris

A new, theoretical analysis finds that about half of the risk factors for Alzheimer's disease are potentially changeable, and that reducing them could substantially decrease the number of new cases of disease worldwide, according to a study to be presented Tuesday at the Alzheimer's Association International Conference.

The study is the first known analysis that tries to quantify and compare how risk factors are associated with Alzheimer's. It will be published Tuesday on the journal Lancet Neurology's website after the conference presentation.

Factors that increase one's risk for Alzheimer's that are considered modifiable include diabetes, high blood pressure, obesity, smoking, sedentary behavior, depression and low educational level, say the authors from the University of California, San Francisco.
Taking Control

While the chances of developing Alzheimer's disease are small, from 5% to 15% for people at retirement age or younger, some lifestyle choices and medical conditions can increase the risk. Here's how various factors increase the chances, by percentage, of developing Alzheimer's:

Physical inactivity 21%
Depression 15%
Smoking 11%
Midlife hypertension 8%
Midlife obesity 7%
Low education 7%
Diabetes 3%

Source: Deborah Barnes and Kristine Yaffe, University of California, San Francisco

In the U.S., physical inactivity is the biggest changeable factor, accounting for 21% of the risk for Alzheimer's, followed by depression and smoking. Added together, the factors account for about 50% of the risk.

If these risk factors were decreased by just 10%, about 184,000 Alzheimer's cases in the U.S. and 1.1 million cases world-wide could be prevented, according to the research. A reduction of 25% on all seven risk factors could prevent nearly half a million cases in the U.S. and more than three million world-wide, the analyses showed.

There are some five million people in the U.S. thought to have Alzheimer's, according to the Alzheimer's Association, and about 36 million cases globally, according to Alzheimer's Disease International.

"The estimates suggest that in the population, up to half of Alzheimer's cases could be modifiable," said Deborah Barnes, a psychiatry professor at UCSF who will present the results. "If we changed those risk factors…it could have this huge impact" at the population level, she said in an interview.

One caveat to these findings: They are based on mathematical models that predict what might happen if the assumptions on which the model was based are real. In this case, the researchers assumed that the risk factors caused Alzheimer's disease, which means that if they were modified, the rates of Alzheimer's would change as well.

In reality, the causes of Alzheimer's are still unclear, and it hasn't been proven that stopping smoking, for example, actually lowers one's risk of getting dementia.

These estimates were calculated based on published data about how frequently the risk factors occur in the population as well as the extent to which each factor increases one's risk of Alzheimer's, known as relative risk.

For instance, depression nearly doubles one's risk of developing Alzheimer's. Each factor alone increases one's risk of Alzheimer's anywhere from about 50% to 100%, according to Dr. Barnes.

The next step in this work is to do prevention trials to try to modify these risks to see if they can actually stave off Alzheimer's, Dr. Barnes says. She hopes to conduct a trial on physical activity, because it "seems like the biggest bang for your buck," because it is known to help the brain, the heart and mood, she says.

Write to Shirley Wang at shirley.wang@wsj.com

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To: tom pope who wrote (6943)7/19/2011 9:33:32 AM
From: ghmm   of 7044
 
My guess is those factors also correlate with longevity and unfortunately that in and of itself may be a bigger risk factor for Alzheimer's :-).

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From: Ian@SI7/21/2011 9:58:29 PM
   of 7044
 
Public release date: 21-Jul-2011

Contact: Les Lang
llang@med.unc.edu
919-966-9366
University of North Carolina School of Medicine

UNC researchers identify seventh and eighth bases of DNA



IMAGE: Dr. Zhang is study senior author of the report published online in Science Express.


CHAPEL HILL – For decades, scientists have known that DNA consists of four basic units -- adenine, guanine, thymine and cytosine. Those four bases have been taught in science textbooks and have formed the basis of the growing knowledge regarding how genes code for life. Yet in recent history, scientists have expanded that list from four to six.

Now, with a finding published online in the July 21, 2011, issue of the journal Science, researchers from the UNC School of Medicine have discovered the seventh and eighth bases of DNA.

These last two bases – called 5-formylcytosine and 5 carboxylcytosine – are actually versions of cytosine that have been modified by Tet proteins, molecular entities thought to play a role in DNA demethylation and stem cell reprogramming.

Thus, the discovery could advance stem cell research by giving a glimpse into the DNA changes – such as the removal of chemical groups through demethylation – that could reprogram adult cells to make them act like stem cells.


"Before we can grasp the magnitude of this discovery, we have to figure out the function of these new bases," said senior study author Yi Zhang, Ph.D., Kenan Distinguished Professor of biochemistry and biophysics at UNC and an Investigator of the Howard Hughes Medical Institute. "Because these bases represent an intermediate state in the demethylation process, they could be important for cell fate reprogramming and cancer, both of which involve DNA demethylation."

Much is known about the "fifth base," 5-methylcytosine, which arises when a chemical tag or methyl group is tacked onto a cytosine. This methylation is associated with gene silencing, as it causes the DNA's double helix to fold even tighter upon itself.

Last year, Zhang's group reported that Tet proteins can convert 5 methylC (the fifth base) to 5 hydroxymethylC (the sixth base) in the first of a four step reaction leading back to bare-boned cytosine. But try as they might, the researchers could not continue the reaction on to the seventh and eighth bases, called 5 formylC and 5 carboxyC.

The problem, they eventually found, was not that Tet wasn't taking that second and third step, it was that their experimental assay wasn't sensitive enough to detect it. Once they realized the limitations of the assay, they redesigned it and were in fact able to detect the two newest bases of DNA. The researchers then examined embryonic stem cells as well as mouse organs and found that both bases can be detected in genomic DNA.

The finding could have important implications for stem cell research, as it could provide researchers with new tools to erase previous methylation patterns to reprogram adult cells.

It could also inform cancer research, as it could give scientists the opportunity to reactivate tumor suppressor genes that had been silenced by DNA methylation.

###

The research was funded by the Howard Hughes Medical Institute and the National Institutes of Health.

Study co-authors from UNC include Shinsuke Ito, Ph.D.; Li Shen, Ph.D.; Susan C. Wu, Ph.D.; Leonard B. Collins and James A. Swenberg, Ph.D.

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From: idos7/22/2011 7:59:36 AM
   of 7044
 
Tobacco Plants Make HIV Antibody

the-scientist.com 

For the first time, a plant-produced antibody gets the green light for clinical trials in the United Kingdom.
By Cristina Luiggi | July 21, 2011

Last month, a monoclonal antibody produced in the leaves of tobacco plants entered phase I clinical trials in the United Kingdom. The antibody, known as P2G12, recognizes an HIV surface protein and is expected to help stop the transmission of the virus, although it has never been tested in humans. The phase I trial, underway at the University of Surrey, will test the safety of vaginally applying the antibody to 11 healthy women.
This is the first plant-produced antibody to be cleared for clinical trials by the Medicines and Healthcare Products Agency (the UK equivalent of the US Food and Drug Administration). Producing the antibody using tobacco plants grown in a greenhouse in Germany is 10 to 100 times cheaper than using conventional methods employing bacteria or mammalian cells Smart Planet reports. “Monoclonal antibodies can be made in plants to the same quality as those made using existing conventional production systems,” Professor Julian Ma from St George’s University, London and joint co-ordinator of the project, told The Guardian. “That is something many people did not believe could be achieved.”

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From: IRWIN JAMES FRANKEL7/25/2011 7:23:26 AM
   of 7044
 

universityofcalifornia.edu 


Common cough medicine may help treat MS
Email this article
Date: 2011-07-07
Contact: Charles Casey
Phone: (916) 734-9048
Email: charles.casey@ucdmc.ucdavis.edu
SACRAMENTO — A drug widely used in over-the-counter cough medicines appears to protect against symptoms of multiple sclerosis, a finding that could offer a new and inexpensive therapy for a condition with few effective treatment options, a study by UC Davis researchers has found.In tests using animal models, the drug, dextromethorphan, was found to significantly reduce the loss of the fatty sheath (or myelin) surrounding nerve fibers in the central nervous system and to minimize the development of paralysis during multiple sclerosis attacks.
The study is available online in the journal Neurobiology of Disease.
"This finding provides an exciting opportunity to better understand the disease and to pursue a new treatment strategy with a drug that is widely available, inexpensive and known to be safe," said Wenbin Deng, principal investigator of the study and assistant professor of cell biology and human anatomy at UC Davis.
Multiple sclerosis affects about 400,000 people in the United States, and most often first appears in young to middle-aged women. It is caused by cells of the immune system attacking myelin, the fatty sheath surrounding nerve fibers in the central nervous system that speeds the transmission of nerve impulses. Symptoms of the disease vary widely and often involve periods of motor problems, including paralysis of a limb or poor coordination, which unpredictably may either go away or become permanent. As the disease progresses, it causes increasing disability and has no known cure. Moreover, many of the current treatments are poorly tolerated and produce a wide range of side effects.
For the current study, investigators induced mice to have either a moderate or severe type of multiple sclerosis and then treated them with either very low or high dosages of dextromethorphan. They found that very low dosages given to mice with moderate disease significantly reduced the loss of myelin and the development of paralysis during acute attacks. The high dosages did not offer any benefit.
"Finding that a chemical like dextromethorphan might be useful for treating multiple sclerosis is especially significant because we already know it is safe," said David E. Pleasure, director of research at the Institute for Pediatric Regenerative Medicine at Shriners Hospitals for Children Northern California in Sacramento and one of the authors of the study. "Normally, a possible new treatment must first undergo years of clinical trials to prove this."
The Shriners-UC Davis research team, which also conducts leading-edge stem cell investigations, began investigating common, over-the-counter cough medicines as treatments for devastating diseases like multiple sclerosis because their molecular structure is similar to morphine. Low dose morphine-like agents — known as morphinans — have been used "off label" for individuals. While these drugs are not cures, they potentially can be helpful for selected patients, and they appear to have little or no toxicity at low doses. The team looked at dextromethorphan because it is one of a few morphinan drugs similar in structure to morphine, but without the addictive properties.
Deng and Pleasure would like to see clinical trials conducted soon to find out if dextromethorphan is effective in humans with multiple sclerosis. Such a trial would likely involve testing in combination with current standard treatment of the disease.
"Dextromethorphan has a different mode of action than current drugs for multiple sclerosis," said Deng, who leads a team of researchers at the Institute of Pediatric Regenerative Medicine. "While current treatment targets inflammation and the immune system, dextromethorphan appears to be more directly neuroprotective. Combining the different strategies could offer a real breakthrough in fighting the disease."
One potential obstacle to further research is obtaining a funding source. Because dextromethorphan is an old drug that no longer has a patent, pharmaceutical companies might be unlikely to invest in such research. The federal government or private multiple sclerosis research societies would be the likeliest sources of funding, according to Pleasure.
The study is entitled "Low dose dextromethorphan attenuates moderate experimental autoimmune encephalomyelitis by inhibiting NOX2 and reducing peripheral immune cells infiltration in the spinal cord." The lead author is Olga V. Chechneva, a postdoctoral fellow in the UC Davis Department of Cell Biology and Human Anatomy. Other authors are Florian Mayrhofer and Daniel J. Daugherty, also from the UC Davis Department of Cell Biology and Human Anatomy, and Jau-Shyong Hong, of the National Institute of Environmental Health Sciences in North Carolina.
The study was in part supported by grants from the National Institutes of Health, National Multiple Sclerosis Society, and Shriners Hospitals for Children.
UC Davis Health System is advancing the health of patients everywhere by providing excellent patient care, conducting groundbreaking research, fostering innovative, interprofessional education, and creating dynamic, productive partnerships with the community. The academic health system includes one of the country's best medical schools, a 645-bed acute-care teaching hospital, an 800-member physician's practice group and the new Betty Irene Moore School of Nursing. It is home to a National Cancer Institute-designated cancer center, an international neurodevelopmental institute, a stem cell institute and a comprehensive children's hospital. Other nationally prominent centers focus on advancing telemedicine, improving vascular care, eliminating health disparities and translating research findings into new treatments for patients. Together, they make UC Davis a hub of innovation that is transforming health for all. For more information, visit healthsystem.ucdavis.edu.

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From: tnsaf7/27/2011 11:08:58 PM
   of 7044
 
FDA Notifies Pharmaceutical Companies that Studies Conducted by Cetero Research May Require Reevaluation

Posted July 27, 2011

The FDA is notifying pharmaceutical companies that bioanalytical studies conducted by Cetero Research, Houston, Texas (Cetero) between April 2005 and June 2010 in support of marketing applications may need to be repeated or confirmed. Cetero is a contract research organization (CRO) that performs bioequivalence and pharmacokinetic testing for a number of pharmaceutical companies.

The FDA is asking drug sponsors to identify those tests conducted by Cetero during the designated time frame that were used to support New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs). Drug sponsors will need to determine whether any of the testing performed by Cetero should be re-done.

Also, the FDA will send letters to drug sponsors with pending applications, requesting that they either repeat the bioequivalence testing done by Cetero or retest drug samples using a different test laboratory or contractor.

It is unlikely that these concerns relating to data integrity affect the overall safety and efficacy of drugs already on the market and, at this time, there is no evidence of problems with the safety, quality, purity or potency of drugs already approved. However, as a precautionary measure the FDA is asking drug sponsors to review the testing in question conducted by Cetero to make sure that data are completely reliable.

FDA is taking this action as a result of two inspections of Cetero's bioanalytical facility in Houston, Texas conducted in 2010, as well as the company's own investigation and third party audit. The inspections and audit identified significant instances of misconduct and violations of federal regulations, including falsification of documents and manipulation of samples.

The pattern of misconduct was serious enough to raise concerns about the integrity of the data Cetero generated during the five-year time frame. FDA concurs with the assessment of Cetero's independent auditor who stated, "This misconduct appears to be significant enough to cast doubt on the data generated...If the foundation of the laboratory is corrupt, then the data generated will be also." As noted in a letter FDA sent to the company, Cetero also failed to conduct an adequate internal investigation to determine the extent and impact of the violations and failed to take sufficient measures to assure data integrity within the 5 year time frame.

As noted in the July 26 letter sent to Cetero, "FDA has reached this conclusion for three reasons: (1) the widespread falsification of dates and times in laboratory records for subject sample extractions, (2) the apparent manipulation of equilibration or ‘prep' run samples to meet pre-determined acceptance criteria, and (3) lack of documentation regarding ‘prep' runs that prevented you from conducting an adequate internal investigation to determine the extent and impact of these violations."

fiercebiotech.com 

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From: tnsaf8/2/2011 11:32:01 AM
   of 7044
 
Potential Universal Cancer Vaccine Will Start Clinical Trials in Ovarian Cancer
[The article is about Immunovaccine, a Canadian penny stock, but mentions several other small companies working on cancer vaccines]

The Pink Sheet Daily. 2011 Jul 26, J Haas
oncologystat.com 

With an IND approval from FDA in hand for a Phase I/II program, Immunovaccine hopes to advance its ovarian cancer vaccine DPX-Survivac quickly and find a partner to acquire either the program or the whole company. Based in Halifax, Nova Scotia, Immunovaccine believes its candidate eventually could become a universal cancer vaccine, treating at least nine different cancers.

Outlining the company's overall strategy at the Biotechnology Industry Organization meeting in Washington, D.C., in June, Immunovaccine Chief Science Officer Marc Mansour said the biotech will test the vaccine first in ovarian cancer. Lack of treatment options for ovarian cancer patients and the short duration of remission patients typically experience following surgery and chemotherapy make this the optimal disease setting for the vaccine, he said.

Immunovaccine's candidate is one of several emerge in the cancer immunotherapy space since the financing environment for such products improved over the past year, thanks largely to FDA's approval of Dendreon's Provenge (sipuleucel-T) for prostate cancer. But the biotech thinks its approach may be especially effective because it is based on attacking an antigen, survivin, commonly found in cancer cells and needed for the cells to survive.

DPX-Survivac combines a survivin-based vaccine in-licensed from Merck KGaA in 2010 with Immunovaccine's proprietary DepoVax technology, which the company claims drives an improved immune response. Merck KGaA was willing to out-license the vaccine, Mansour said, because the pharma wanted to focus on later-stage programs, including the cancer vaccine Stimuvax.

Mansour said the survivin antigens formulated with DepoVax technology activate "those types of T cells that you need floating around looking for cancer cells. They're more active, they're better activated."

Survivin is a tumor-associated antigen present in many cancer cells and not generally expressed in normal cells, according to the company. The National Cancer Institute has classified survivin as a promising cancer antigen because of its specificity to cancer cells - it is found in up to 90% of ovarian cancers. But Immunovaccine's approach is not to block survivin, but to use survivin as a flag to help the immune cells its vaccine activates find and kill cancer cells.

"If you block survivin with a drug, the cell cannot survive. It goes through programmed cell death and it dies," Mansour explained. "What we're doing with our vaccine is teaching the immune system to target cancer cells that express survivin so that the immune cells will circulate and home in on cancer cells that express survivin and kill them."

Besides ovarian cancer, Immunovaccine believes DPX-Survivac could prove effective in melanoma, multiple myeloma and prostate, pancreatic and colorectal cancers.

Having demonstrated in a Phase I trial of another vaccine, DPX-0907, that DepoVax formulations are both safe and active in human subjects, Immunovaccine sought permission from FDA to run a small Phase I trial followed immediately by a larger Phase II study it hopes will generate data to attract potential partners.

The program will begin later this year with a 15-patient open-label dose-ranging study to determine the optimal dose for use in Phase II. The company expects to have that Phase I data by the third quarter of next year, and then begin a 250-patient, placebo-controlled Phase II proof-of-concept trial in the fourth quarter of 2012. The trial will last an expected two and a half years and begin generating interim data in late 2013, Mansour said.

"FDA has bought into this concept of doing a Phase I/II combined and we can do the Phase I and move directly into Phase II without going back to the agency," he said. "That's a big savings in time and money, which for an early-stage biotech is very important."

Immunovaccine, whose shares are traded on the TSX Venture exchange, reported $10.4 million cash on hand at the end of 2010. This included proceeds from a follow-on public offering in which it raised $7.465 million by selling new stock for $1 per share.

Patients in the Phase II trial will be women recently diagnosed with ovarian cancer who have had surgery and chemotherapy. They then will receive the vaccine to see if it will prolong their remission period.

"For a cancer vaccine to work, it has to be used in the early stages of the disease," Mansour explained. "When you have newly diagnosed ovarian cancer patients who will get surgery and then chemotherapy, they wait for about a year and a half and then the cancer will come back. During that period, you can vaccinate."

"The tumor has been eliminated by treatment but there are always cancer cells floating around. They escape treatment, get established and the cancer will come back," he continued. "Those are the kind of cancer cells you are trying to target using your immune system - you're teaching your immune system to target those floating cells and delay the cancer from coming back."

Immunovaccine, which derives some royalty income from a partnership with Pfizer Animal Health, which has licensed the DepoVax technology to enhance its animal vaccines, hopes Phase II data will be sufficiently strong to drive a lucrative big pharma partnership. In the meantime, the company will look to additional platform license deals to increase its income.

"If the Phase II trial is successful, I don't think finding a partner will be a very difficult task," Mansour said. "That's when big pharma will be likely to line up and look to acquire it. And so that's an exit strategy at that point for either the product or the company."

According to data collected from Elsevier Business Intelligence's Inteleos database, there are at least 10 other companies with unpartnered cancer vaccines currently in Phase II of development. These include: Bellicum Pharmaceuticals' BPX-101 for prostate cancer, Quantum Immunologics' breast cancer vaccine, Celldex Therapeutics' CDX-1401 for solid tumors, Immunovative Therapies' AlloStim for various cancer types, Geron Corporation's GRNVAC1 for acute myelogenous leukemia, New Link Genetics' Hyperacute vaccine for prostate and pancreatic cancer, Immatics Biotechnologies' IMA-901 for renal cell carcinoma, Avex Technologies OVax for advanced ovarian cancer, Inovio Pharmaceuticals' PSMA-based prostate cancer vaccine, and Vaxon Biotech's VX-001 for advanced solid tumors and non-small cell lung cancer.

Another method the biotech is using to try to drum up collaboration business is its "DepoVax Challenge," in which it asks other vaccine companies to send a copy of their candidates to be formulated with the DepoVax technology for no charge. Mansour said Immunovaccine has several of these agreements in progress.

"We tell other companies, 'you have a vaccine, obviously it needs enhancements, send us your vaccine and we'll formulate it for you and send it back to you,'" he said. "Then, they get to test it in their animal models and if they like it, we'll talk. This doesn't cost anything; it's a simple research agreement."

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From: Ron_8/8/2011 5:00:29 PM
   of 7044
 
"Aug 8 (Reuters) - Array BioPharma said it signed a deal worth up to $685 million with Genentech, a unit of Roche Holding AG , to develop cancer compounds, sending Array's shares up 9 percent after market"

reuters.com 

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