A drug that’s already approved by the FDA has shown promise in clearing away a plaque in the brain that’s associated with Alzheimer’s disease, Case Western Reserve University researchers have found.

The drug, bexarotene (brand name Targretin), in mice was able to reduce levels of Beta-amyloid plaque, a protein fragment that builds up in the brains of people with Alzheimer’s, according to a statement from the university.

Case touted the research as “a dramatic breakthrough in [the] effort to find a cure for Alzheimer’s disease,” but it’s important to note that research won’t mean anything for people suffering from Alzheimer’s until the results are replicated in humans, and that’ll likely take several years. Nonetheless, the findings certainly represent a ray of hope in someday treating Alzheimer’s patients.

“We were shocked and amazed,” Gary Landreth, the study’s senior author, told AFP. “Things like this had never, ever been seen before.”

The researchers said bexarotene works by elevating levels of a substance that clears away beta amyloid from the brain.”Think of this as a garbage disposal,” Landreth told AFP.

Bexarotene is generally used to treat a type of skin cancer.

CWRU researchers were struck by the speed with which bexarotene improved memory deficits and behavior as it also acted to reverse the pathology of Alzheimer’s. Within six hours of administering the drug, some amyloid levels dropped as much as 25 percent, according to the statement.

“This is an unprecedented finding,” said another of the study’s authors. “Previously, the best existing treatment for Alzheimer’s disease in mice required several months to reduce plaque in the brain.”

Landreth said he hoped to begin human testing “within the next few months.”

The brand-name version of bexarotene, Targretin, was developed by San Diego biotech company Ligand Pharmaceuticals (NASDAQ:LGND), which received U.S. Food and Drug Administration approval on the drug in 1999. Eisai acquired Targretin and three other cancer products from Ligand in 2006 for $205 million. Targretin’s patents expire in 2016.

The Cleveland Clinic and Case Western Reserve University will form the Cleveland Traumatic Neuromechanics Consortium, the institutions announced Friday, pairing the Clinic’s talent in medical research, imaging tools and patient care with Case’s engineering expertise, especially in the area of neurology. It will focus on collision injuries from sports, military and automobile accidents.

The Cleveland Clinic was ranked the sixth best hospital in the country for neurology and neurosurgery by U.S. News last year, and it already has a lot brewing in the area of traumatic brain injury. Researchers are developing a biomarker blood test and an iPad2 app that are aimed at identifying concussions in football players, and a mouthguard that could measure the impact of blows to the head among athletes.

The partnership could help the Clinic gain ground in this area on other institutions known for their neurology programs like Johns Hopkins, Massachusetts General Hospital and Mayo Clinic, which announced in 2010 it would work with Intel Corp. to develop computer simulations for assessing the risk of head injuries.

Northeast Ohio also has a variety of companies working on technology for neurological injuries, including high-profile company Athersys, which is developing a regenerative medicine technique called MultiStem for treatment of traumatic brain injury. Cleveland-based Life Core Technologies is also developing a medical device to cool the brain of patients who sustain brain trauma.

CardiaLen Inc. has secured $2.4 million for its implantable low-voltage atrial cardioverter, technology developed by Prof. Igor Efimov and licensed from Washington University and Case.

Atrial fibrillation is the most common form of cardiac arrhythmia and increases a person’s risk for stroke and premature death. Since patients typically remain conscious during episodes, a pain-free operation is essential to AF treatment, according to CardiaLen.

Founded in 2008, CardiaLen has facilitated the development of its technology by raising more than $1.2 million in seed capital in 2009 and 2010. It also raised $1.1 million from Broadview Ventures in 2011 and more than $450,000 in government grants. Other investors include St. Louis Arch Angels and BIOGenerator.

CardiaLen operates its clinical headquarters in St. Louis and operates a production facility in St. Paul, Minnesota. A phone message to CEO Bob Calcaterra seeking more information was not returned.

Dr. Fabio Cominelli

Researchers from Case Western Reserve University have received a $6.75 million federal grant to study a recently discovered cause of inflammatory bowel disease.

The grant will fund research into the role the innate immune system plays in causing Crohn’s disease, a form of inflammatory bowel disease that affects the intestines. The innate, or nonspecific, immune system is the body’s first line of defense against invading organisms.

Previously, Case researchers have found a deficit of disease-fighting cells in the innate immune systems of mice suffering from a type of Crohn’s disease, according to a statement from Case.

The research is led by Dr. Fabio Cominelli, chief of the division of gastrointestinal and liver disease at Case’s School of Medicine and director of the Digestive Health Institute at University Hospitals Case Medical Center.

“We are very excited about this opportunity to study this unique mouse model of IBD and make important discoveries that can be directly applied to improve patient care and developing novel therapeutic modalities for this devastating disease,” Cominelli said in the statement.

The grant comes from the National Institute of Diabetes and Digestive and Kidney Diseases.

A hernia mesh implant patch

A Case Western Reserve University spinoff that’s developing controlled-release, drug-delivering polymer technologies is hoping to land some federal grants.

Affinity Therapeutics’ ability to win funding through the  federal government’s Small Business Innovation Research (SBIR) program will go a long way in determining the company’s future direction.

The company was founded by Case researcher Julius Korley and biomedical engineering associate professor Horst von Recum. It derives its name from what the founders call its “affinity-based” technology, which is to say that the technology uses chemical interactions to regulate the rate at which a drug is released from an implant in a patient’s body.

Affinity’s founders envision the company’s technology being used to coat a wide range of medical devices with various types of pharmaceuticals, though the company is also developing stand-alone delivery systems.

Thus far, the most promising application of Affinity’s technology looks to be for coating hernia mesh with antibiotics. While mesh implants can increase the likelihood of successful hernia repair, they’re also prone to infection.  The infections sometimes show within weeks of hernia surgery, but in some cases don’t develop for years.

Affinity’s founders believe the company’s polymer-based technology could deliver antibiotics to help combat those infections. The key value of Affinity’s technology is its ability to control the rate and duration at which a drug is released in a patient’s body, the founders said.

For example, existing controlled-release technology often lets out a large amount of a drug in the first few days after a device is implanted, whereas Affinity’s drug-delivery method has shown the ability to hold a drug for up to six months and to prevent infection in animal models, von Recum said.

In addition to hernia mesh, wound healing could be a promising application for Affinity’s drug-delivery method, according to Korley and von Recum. “Our strategy is to find the applications that require the least-stringent rules from the FDA,” von Recum said.

But before Affinity can get anywhere near a U.S. Food and Drug Administration review, it’ll first need to obtain financing to lease lab space and fund further research. The company has applied for five SBIR grants, and “we’ll be excited if one or two show up,” Korley said.

In addition to grants, a licensing deal with a pharmaceutical or medical device company would represent another means of funding the development of Affinity’s technology. Affinity has already engaged in such talks, the founders said.

Affinity’s research has thus far been financed mainly through Case’s translational research program, which is funded by the Wallace H. Coulter Foundation.

Kenneth Gustafson

A Case Western Reserve University spinoff is developing a neurotechnology medical device for patients suffering from urinary problems due to spasms in the urethral sphincter.

Cleveland-area Conservocare is looking to continue animal testing of the device over the next year or so, and then file for regulatory approval to begin testing the device in humans, said Kenneth Gustafson, a Case biomedical engineering and Veterans Administration researcher who’s helping lead the project.

Urethral sphincter spasms often occur after spinal cord injuries. The spasms cause blockages that prevent the  bladder from emptying of urine, and that can lead to problems like kidney failure or autonomic dysreflexia, a potentially life-threatening condition that causes abrupt onset of excessively high blood pressure.

One option for treating the condition is a sphincterectomy, which is likely even more unpleasant than it sounds. The operation helps the kidneys, but patients must live the rest of their lives with urine collection bags. Gustafson calls the operation “irreversible and not very satisfactory,” which is probably an understatement.

Conservocare’s device sends electrical signals to the nerve responsible for causing the spasms, which eliminates the spasms and allows the bladder to empty.

“Conceptually, it’s fairly simple,” Gustafson said.

Conservocare’s technology is similar to that of Neuros Medical – another Case spinoff, which is developing a pain-blocking device for amputees, according to Gustafson.

Researchers have been performing preclinical testing on the device for about seven years, so it’ll be a huge milestone if Conservocare progresses to human testing.

The company and the research it’s based on have thus far been financed by federal grants and Case’s translational research program that’s funded in part by the Wallace H. Coulter Foundation.

The five-year grant from the National Heart, Lung, and Blood Institute will enable researchers to study how sleep apnea produces functional and structural changes in the heart that could contribute to the development of atrial fibrillation, the most common type of irregular heart rhythm, according to a statement from Case.

Case researchers have previously established a strong association between sleep apnea and atrial fibrillation, but the research did not include information that characterized changes in heart structure. The aim of the new research is to gather more specific data obtained by examining images of the heart that detail its pumping function and the condition of its walls, according to the statement.

“The data generated from the research will fuel the development of new approaches for prevention and treatment of atrial fibrillation, and will help identify key factors for future clinical trials,” said Dr. Reena Mehra, the study’s principal investigator and an associate professor of medicine at Case.

Sleep apnea results in intermittent lowering of oxygen levels, alteration of nervous system function and pressure changes within the chest, causing changes in the heart. Some or all of these factors may increase the likelihood of atrial fibrillation, Mehra said.

Dustin Tyler

A Case Western Reserve University spinoff developing a neuromodulation device to help patients with breathing tubes to swallow is looking to build a prototype of the device and begin a clinical trial early next year.

The device is intended to replace existing tracheostomy tubes, and works by electrically stimulating a nerve in the neck to activate the vocal cord folds to simulate a swallowing motion.

The company developing the device goes by the temporary title of BEAR, which stands for Biomedical Engineering and Research. The company was previously known by the informal title Swallowing Solutions, but that name was never intended to be the company’s long-term identity, according to Dustin Tyler, an associate professor of biomedical engineering at Case who is leading the research project.

Following strokes or neurodegenerative diseases like Parkinson’s, patients can lose their ability to swallow, so they must be fed and hydrated through feeding tubes. Using an electrical device to stimulate normal swallowing could significantly improve the quality of life for these patients, according to the thinking behind the company.

First, though, the company must complete a prototype of the device and then begin testing it on humans. Plans call for a roughly 30-patient trial to begin early next year and wrap up around the end of the first quarter, Tyler said.

“What we’re going to figure out in the trial is the details of how we can make this system work,” he said.

Key insights the company hopes to glean from the trial include how the device feels to the user, exactly where on patients’ bodies to apply the stimulation and the optimal strength and timing of electricity delivery.

Roughly 700,000 U.S. patients could benefit from the device if it works as the company hopes, Tyler said.

Armed with successful clinical trial results, the company’s next steps would involve obtaining investment funding for further trials aimed at helping secure U.S. Food and Drug Administration approval of the device.

BEAR has received funding for its research and development through Case’s translational research program that’s funded in part by the Wallace H. Coulter Foundation.

CWRU President Barbara R. Snyder and Coulter Foundation's Sue Van

Case Western Reserve University and the Wallace H. Coulter Foundation have created a $20 million endowment that’s aimed at translating biomedical research into commercial products and clinical practices.

The creation of the endowment will allow Case’s translational research program funded by the Coulter Foundation to continue in perpetuity. The program was created in 2006 with a $4.8 million grant from the Coulter Foundation to Case, according to a statement from the university.

The program at Case  has helped launch six startup companies and has funded 62 translational research projects. Examples include projects involving the development of advanced imaging technology techniques and thermally-stable insulin.

Case was one of just six U.S. universities to receive the endowment funding from Coulter. The others are Drexel University, Duke University, University of Michigan, Stanford University and University of Virginia.

The Coulter grants work differently than those from the National Institutes of Health and other federal research agencies, more closely resembling a business model, according to Jeffrey Duerk, chairman of biomedical engineering at Case.

““The projects have quarterly milestones and can be shelved by the oversight committee if milestones are not met,” he said. “With the Coulter process, there is strong emphasis on the successful transfer to commercialization.”

The late Wallace H. Coulter, benefactor of the foundation that bears his name, was a serial innovator and entrepreneur. He founded Miami, Florida-based medical diagnostics company Coulter Corporation, now part of Beckman Coulter (NYSE:BEC).

Coulter Corporation developed several innovations for hematology and laboratory medicine, including the Coulter Principle, a method for counting and sizing microscopic particles suspended in fluid that led to automation and quick analysis of complete blood counts.

As director of the Coulter-Case Translational Research Partnership, Drummond is behind a $1 million fund that often invests in technologies spun out of Case.

Drummond discusses a few spinoff companies, including next-generation insulin developer Thermalin Diabetes and stroke device start Swallowing Solutions.

The grant comes from the KeyBank Foundation, and follows another $1 million gift from the foundation in 2007 for the same program, the Plain Dealer reported. The money will go towards helping students with living expenses and other costs.

African-American and Hispanic students make up about 20 percent of each 32-member class at the medical school, which is a partnership between the Clinic and Case that was established in 2002.

A lack of diversity among American medical students contributes to “training and treatment environments that are biased, intolerant and contributory to health disparities,” according to the American Medical Student Association.

Racial and ethnic minorities make up 26 percent of the U.S. population, but only about 6 percent of practicing physicians are Latino, African American and Native American, according to the group.

The sheer size of the grant from the National Cancer Institute,   and the company it puts Case in, make the grant a big deal for the university. Just six other institutions, including Johns Hopkins University and Harvard, have the same federal designation as centers of excellence for gastrointestinal cancer research, according to a statement from Case.

Case is the only institution this year to have received this federal designation for research on gastrointestinal cancers, which has been given the memorable acronym of SPORE — a Specialized Program of Research Excellence.

The new center’s focus will be to develop new treatments for colon cancers and cancers of the esophagus. Colon cancer is the second-leading cause of cancer death in the U.S., according to the statement.

The gastrointestinal cancer research center will be directed by Dr. Sanford Markowitz, a professor of cancer genetics at Case  and a medical oncologist at University Hospitals Seidman Cancer Center in Cleveland (and an apparent bow-tie enthusiast).

Some of the highest priorities for researchers at the new center will include developing: new drugs to prevent colon cancer, new tests to identify people at risk of colon cancer, as well as new tests to distinguish colon cancers that can be cured by surgery alone from cancers that instead require further treatments, like chemotherapy and radiation.

Invacare (NYSE:IVC) founders Malachi Mixon III and J.B. Richey II have made a $5 million donation to Case Western Reserve University that’s aimed at bolstering the university’s innovation initiatives.

The gift will go toward the establishment of a Richey-Mixon Building, which would include space for Case’s school of engineering, as well as space for startups and established companies to work collaboratively with representatives of the university, according to a statement from Case.

Case officials are exploring locations for the building, including the possibility of renovating an existing facility.

In the late 1970s, Mixon led a group of investors that included Richey in a $7.8 million buyout that led to the formation of Invacare  as  a standalone company. Mixon served as Invacare’s CEO until last year, when he stepped down from that role, though he remains the home healthcare products company’s chairman. Richey is president of Elyria, Ohio-based Invacare’s technology division.

“For me, personally, this building is about honoring J.B. [Richey], who is a Case graduate and helped me build a business in this region through great engineering ideas,” Mixon said. “But beyond that, we want to be a part of helping the next generation of young people with vision take some risks and generate some companies and a new birth for Cleveland.”

Mayfield Village, Ohio-based BioInVision is kicking off the formal marketing launch of its “cryo-imaging” service at the World Molecular Imaging Congress  this week in San Diego, president Debashish Roy said.

The technology is so sensitive that it allows researchers to drill down to view the location of single cells in an animal’s particular organ. That level of detail is desirable to pharmaceutical and stem cell researchers who’d like to see exactly how the substances they’re studying are distributed in the body.

Broadly speaking,  BioInVision “wants to help our customers solve biotechnology problems with our unique imaging solutions,” Roy said.

The company aims to do that through its “cryo-imaging” technology, co-invented by Roy and David Wilson, a professor in Case’s department of biomedical engineering. “For a researcher, it’s like virtually dissecting a mouse,” Roy says of the technology.

Here’s how it works: First, a mouse is euthanized and flash frozen. Its body is then placed in the cryo-imaging device, which cuts the body into about 500-plus ultra-thin slices. The slices are imaged at a very high-resolution and more than 10,000 images (that’s over 60 GB of data) are stored in a powerful software application. The software program then uses these images to create a 3-D reconstruction of the animal that researchers can digitally zoom in and out of to navigate throughout the body. By tagging the cells of interest with off-the-shelf fluorescent-labeling kits, researchers can view the location of single cells anywhere within the mouse.

One big advantage to BioInVision’s business model is that, since its device is only intended for animal use, it doesn’t need any of the sometimes-lengthy and expensive federal regulatory reviews required of devices intended for use in humans.

The company is taking a two-pronged approach to its business: First, customers can ship frozen samples for BioInVision technicians to process, and then the company will deliver back to customers over the web images and the movies of the reconstructed 3-D digital mouse. Or customers can simply buy the cryo-imaging equipment for themselves, though Roy acknowledges that the device is expensive.

BioInVision has thus far sold “a couple” of the devices, though the service part of its business currently plays a bigger role. Availability of the company’s services has spread only through “word of mouth” among big research institutions and drug companies so far, since BioInVision hasn’t yet engaged in much formal marketing, he said.

That gets at what Roy calls the company’s biggest challenge: market education.

“As with any new technology, we need to first go out and educate the potential customer to its benefit,” he said.

NeoProteomics will use the funding to further refine its bioinformatics software, which is used by clients in the research industry to develop and discover new biomarkers for disease, according to a statement from Case. Biomarkers are proteins in the blood that can indicate the presence of a certain disease.

Pharmaceutical companies can use the biomarkers that NeoProteomics develops for research and analysis, which can help speed up drug development.

The company also has completed a 20-year licensing deal with Case for the software. Rather than taking a payment for the deal, Case receives a 15 percent ownership stake in the company. NeoProteomics will also pay Case a royalty from each sale.

“These two milestones represent goals the company has been working on for quite some time,” CEO John Schenkel  Jr. said in the statement.

NeoProteomics was co-founded by Mark Chance, director of Case Center for Proteomics and Bioinformatics. He’s also the company’s chief scientific officer, as well as interim chair of Case’s department of genetics. “We are just beginning to discover how important software is to the detection and cure of human disease,” he said.

The paper suggests that a major component of last year’s controversial federal health overhaul, insurance exchanges, could help consumers extract better value from their health plans by making comparison shopping easier, according to a statement from Case. Set to begin in 2014, the exchanges are health insurance marketplaces that will serve individuals buying insurance on their own and small businesses with up to 100 employees.

The overpayment problem cited in the research paper can be attributed to a concept known as “search friction,” which occurs when consumers can’t easily compare all the options available to them in the marketplace.

“What our paper shows is that this ‘shopping problem’ has important implications for how market competition plays out,” said co-author Mark Votruba, an associate professor of economics at Case.  “If consumers have a hard time evaluating value, competition becomes less about value and more about marketing.”

The research paper, “Unhealthy Insurance Markets: Search Frictions and the Cost and Quality of Health Insurance,” was published in the August issue of American Economic Review. Researchers from Boston University and Carnegie Mellon also worked on the paper.

The five-year grant comes from the National Cancer Institute and will help Case researchers examine “immune tolerance,” a process that keeps tumor cells from being detected by the immune system, according to a statement from Case.

The research team will be led by Dr. Alex Huang, an assistant professor of pediatrics, pathology and biomedical engineering with Case, and a hematologist and oncologist at Rainbow Babies & Children’s Hospital at University Hospitals Case Medical Center.

Huang hopes to one day apply the research to pediatrics.

The company, NeoProteomics, was co-founded by Mark Chance, director of Case Center for Proteomics and Bioinformatics. NeoProteomics focuses on the identification and validation of biomarkers, proteins in the blood that can indicate the presence of a certain disease, according to a statement from Case.

Pharmaceutical companies can use the biomarkers that NeoProteomics develops for research and analysis that can help speed up drug development.

The company hopes to use its biomarkers to enhance treatments for a range of conditions, including cancer, diabetes and inflammatory diseases. The new license option covers various tools and biomarkers that will expand the company’s portfolio, according to the statement.

In a 2009 interview, Chance said he viewed himself as the bridge between the lab and NeoProteomics’ business. “The hard part has been picking the right [biomarkers] that look like they might have commercial potential,” Chance said. “A lot of the projects we do have tremendous basic science potential … but most of them are too far away from commercialization.”

NeoProteomics has already begun selling software it licensed from Case. The data analysis software, called ProtMapMS, has been licensed to major pharmaceutical companies and research universities.

In 2009, NeoProteomics received a $25,000 grant from the Innovation Fund of the Lorain County Community College Foundation.

Mark Coticchia‘s resignation is effective April 1. He joined Case in 2001, according to a statement from the Cleveland, Ohio, university.

“I’m an entrepreneur at heart and I love to launch businesses and build things,” Coticchia said in a phone interview.

Coticchia’s responsibilities at Case extended beyond tech transfer to research administration and economic development.

During Coticchia’s time with Case, the university created 29 spinoff companies that have attracted more than $200 million in venture capital. 2009, in particular, was a highlight for Case’s tech transfer office, which generated more than $16 million in licensing revenues during the year.

“In the past 10 years, we’ve had a hell of a run,” Coticchia said.

Other highlights include 161 patents issued during Coticchia’s tenure and more than 20 products based on Case technology that entered the market.

“Over the past decade, Mark built our technology transfer office into an operation renowned nationally for its success,” said Case President Barbara Snyder. “I am grateful for his extraordinary contributions, and wish him all the best in his next professional venture.”

Coticchia’s new company is called RedWind Innovations, and he plans to open offices in Cleveland, Columbus, Detroit, Pittsburgh and Research Triangle Park, North Carolina. In addition to helping universities and hospitals implement tech transfer programs, Coticchia plans to develop intellectual property management software that the company will sell.

The company will also help develop business incubators and put together groups of investors to fund specific deals. “It’s a pretty wide range of services,” Coticchia said in an understatement.

In the beginning, Coticchia will fund the company himself. “I have a book of business identified and I’m going to be able to bootstrap this, at least initially,” he said. “I may need to bring in some growth capital down the line.”

Before coming to Case, Coticchia was a senior director in Pittsburgh at Redleaf Group, an early stage venture capital firm. He’s credited with expanding and organizing Case’s tech transfer office, connecting it with independent economic development groups, and making it more prominent on and off campus.

Companies that the tech transfer office has helped create include: regenerative medicine firm Arteriocyte, heart-mapping technology maker CardioInsight Technologies and chronic-pain device developer Neuros Medical.

Coticchia said CardioInsight is the spinoff he’s most proud of, because launching the company was “such a community effort,” which included contributions from Cleveland economic development groups JumpStart and BioEnterprise and funding from Pittsburgh-based venture group Draper Triangle Ventures.

Case’s statement made no reference to a successor for Coticchia, or even a search for one.  One candidate could be Joe Jankowski, a veteran of Case’s tech transfer program who holds the title of associate vice president of technology management. Coticchia said he didn’t want to speculate on a successor.

Bioptigen makes a medical device that allows for imaging of  the inner areas of the eye. The company has marketed the product for research as well as medical applications.

The FDA’s Feb. 9 letter raised a warning about Bioptigen’s hand-held imaging device. The company, based in North Carolina’s Research Triangle Park, received 510(k) clearance in 2006 on a tabletop scanner for use in the “evaluation of ophthalmic tissue in routine clinical examinations as an aid in the diagnosis of conditions that affect the optical scattering properties of ocular tissue.”

The FDA letter said that the hand-held imaging system represents a modified device design. The FDA said that Bioptigen’s website and brochures claim that the hand-held system may be used for specific diagnostic purposes such as retinopathy of prematurity, pediatric retinoblastoma and shaken baby syndrome. These changes are outside of the company’s 510(k) clearance, the letter said.

Bioptigen CEO Eric Buckland acknowledged the warning letter but he declined to answer questions.

“We are preparing a response,” he said. “I’d rather not talk about it until after we submit the response.”

Bioptigen was founded in 2004 based on spectral domain technology developed in the biomedical engineering department of Duke University’s Pratt School of Engineering. Bioptigen licensed the technology from Case Western Reserve University, where Professor Joseph Izatt initially worked on the technology before leaving for a position at Duke University in 2001.

Bioptigen’s imaging systems use a technology called optical coherence tomography, or OCT. The company’s website describes OCT as analogous to ultrasound, using light waves instead of sound waves. The backscattered light is processed to develop a high-resolution image that can be used for analysis without physical contact with the subject. That makes the technology particularly helpful with non-cooperative patients, such as infants.

Bioptigen’s last round of financing was also its first, a 2006 series A round that brought Bioptigen $1.3 million from the Piedmont Angel Network of Greensboro, North Carolina, along with several individual investors.

Dr. Michael Lederman

Researchers from Cleveland Clinic and Case Western Reserve University have received a three-year, $3 million grant to study HIV and the body’s response in autoimmune diseases.

The grant comes from the Richard J. Fasenmyer Foundation, according to a statement from the Clinic and Case.

Immunologists Dr. Leonard Calabrese from the Clinic and Dr. Michael Lederman from Case will continue their nearly 30-year collaboration to investigate potential relationships between autoimmune, inflammatory diseases, such as rheumatoid arthritis, and HIV and AIDS.

“In addition to helping us better understand why some people exposed to HIV do not get infected, this grant ultimately will help amplify current research to apply what we’ve learned about HIV immunology to better understand a host of other diseases,” Lederman said.

The research will also examine why many well-treated HIV patients fail to achieve a restored immune system despite effective therapy for the disease.

Fasenmyer died in 2002 and was the founder of RJF International Corp., which manufactures and distributes wall coverings.

The grant comes from the National Institutes of Mental Health. It will fund the continuation of a study launched five years ago in which 707 children between the ages of six and 12 were evaluated for elevated symptoms of mania, a common indicator of bipolar disease and other childhood psychiatric disorders, according to a statement from Case.

Children participating in the study’s initial phase have been evaluated every six months for their psychiatric diagnoses, symptoms, use of mental health services and medication, and psychosocial function.

Researchers are hoping to learn more about what factors make children with elevated symptoms of mania more likely to develop a bipolar disorder. “We want to develop the means by which to more accurately diagnose bipolar disease in children,” said Robert Findling, the study’s coordinating principal investigator and a professor of child and adolescent psychology.

Researchers found that administering Athersys’ MultiStem technology to rodents with spinal injuries reduced inflammation and promoted the regrowth of neurons, according to a statement from Athersys and the Case Western Reserve University School of Medicine.

The study was conducted by Athersys and Case researchers and will be published in the January issue of The Journal of Neuroscience.

“This study demonstrates for the first time that an adult stem cell is capable of modifying multiple aspects of the wound response following a spinal cord injury,” said Jerry Silver a professor in Case’s Department of Neurosciences.

For Athersys, the study represents yet another potential application of MultiStem, an off-the-shelf stem cell treatment derived from the bone marrow of adults or other non-embryonic sources. MultiStem is also being studied in the treatment of blood cancer, cardiovascular disease and inflammatory bowel syndrome. Its most promising application may be for stroke.

Still, because MultiStem has only been tested for spinal injury in rodents thus far, it’s many years away from being ready for the regulatory review required to enter the market — and that’s if everything goes well in subsequent years of testing.  “Significant research remains before we can apply these methods in human therapy,” Athersys CEO Gil Van Bokkelen said.

Earlier this month, Athersys said it had completed patient enrollment in the single-dose portion of a clinical trial that’s treating blood cancer patients with MultiStem.

Dr. Allen Roses

A new Alzheimer’s disease test developed by a Durham, North Carolina, pharmaceutical company has  been licensed by Takeda Pharmaceutical Co. in a deal valued at up to $87 million.

Under the agreement announced this week, Zinfandel Pharmaceuticals receives an up-front payment of $9 million. Additional milestone payments of up to $78 million would go to Zinfandel if Osaka, Japan-based Takeda reaches development milestones.

Takeda receives an exclusive license with the right to sublicense, develop, make use of and commercialize Zinfandel’s TOMM40 biomarker assay. The companies are studying pioglitazone, the active ingredient in Takeda’s drug Actos. Zinfandel’s assay can be used to identify candidates for testing of Actos in Alzheimer’s patients. The connection between Actos and Alzheimer’s was initially made through research done by the University of Virginia and Case Western Reserve University.

The deal is clearly a win for Zinfandel, a small drug company started by CEO Allen Roses, who is also a Duke University neurobiology and neurology professor. But it could also be significant for Takeda, whose Actos is known to patients as a diabetes drug. Takeda took great pains last summer to distinguish Actos from GlaxoSmithKline’s (NYSE:GSK) diabetes drug Avandia, which has been linked with serious and sometimes fatal heart risks. Avandia is now all but finished as a drug, withdrawn from the European market and allowed in the United States only with strict warnings. Actos is in the same drug class as Avandia, and in the eyes of some, it carries risk by association.

Development of Actos for treating Alzheimer’s could breathe new life into the drug by adding a new indication, one with plenty of potential patients. An estimated 18 million people worldwide currently suffer from Alzheimer’s disease.

The grant comes from the National Eye Institute and goes to the departments of pharmacology and ophthalmology and visual sciences in Case’s medical school, according to a statement from the university.

The aim of the research is to increase the speed with which basic science discoveries are used to develop new therapies for complex retinal disorders. Conditions affecting the retina, the tissue in the back of the eye responsible for vision, are among the leading causes of blindness in adults.

Among those conditions is age-related macular degeneration, the main cause of blindness in adults over the age of 55, according to the statement.

“Our goal is to develop new drugs based on the screening of FDA-approved drugs to evaluate their effectiveness in treating retinal diseases,” said Krzysztof Palczewski, chair of the department of pharmacology and principal investigator  of the research funded by the new grant.

Palczewski and his team have already examined 24 FDA-approved drugs for their ability to attack the buildup of harmful toxins in the retina. At least 16 of the drugs tested have already demonstrated the potential to limit the progression of retinal diseases. The resulting data provided the basis for funding the $10 million grant request, according to the statement.