Foresight Biotherapeutics, a pharmaceutical company focused on diseases of the eye and ear, has announced the results of a pre-clinical study of their FST-100 solution to treat adenoviral conjunctivitis. In the study, FST-100 performed significantly better than other treatments for adenoviral conjunctivitis, including the current experimental “gold standard” topical cidofovir.

The study, performed at the Louisiana State University Eye Center, was conducted on 20 rabbits who were injected with human adenovirus type 5. The animals were randomized into groups and treated for eight days with one of four topical solutions: FST-100,  0.5% cidofovir, Tobradex ophthalmic suspension, or a placebo. Researchers looked at factors including eye discharge, eyelid inflammation, and excessive tearing. The rabbits treated with FST-100 showed dramatic signs of improvement within 48 hours. They were the only group to reach complete clinical resolution in the study. The other rabbits experienced inflamed corneas and eyelids, along with conjunctival inflammation.

 Cidofovir is made by Gilead Sciences; Tobrodex is a product of Alcon. Another form of conjunctivitis is bacterial conjunctivitis, commonly treated with antibiotic eyedrops such as Merck’s Gentamicin or Alcon’s Vigamox. In May, the FDA approved Bausch and Lomb’s Besivance for bacterial conjunctivitis.

Eisai Corporation of Woodcliff Lakes, NJ, is one of the few pharmaceutical companies developing treatments for MDS. The company announced today that the U.S. Food and Drug Administration accepted for review the company’s supplemental new drug application for an alternative five-day dosing regimen for its MDS drug Dacogen. Dacogen is designed to help regulate bone marrow function, increasing the number of healthy blood cells and decreasing the need for blood transfusions. The drug is typically infused over a three-hour period every eight hours, for three consecutive days. Patients need to repeat the treatment cycle every six weeks. The alternative dosing method submitted to the FDA only requires one infusion per day, with a decreased administration time.  If approved, the new method would be more convenient for patients. Drugs such as Dacogen or Celgene’s Revlimid can help slow the progression of the disease. Last year, the FDA approved Celgene’s chemotherapy drug Vidaza to treat higher-risk MDS patients. Another company working in this space is SGX Pharmaceuticals.

Esai of North America is owned by Tokyo-based Eisai Co., producer of top-selling Alzheimer’s drug Aricept. Eisai Co. recently announced plans to expand into emerging markets.

ATS Labs tested the Ygiene Hospital Grade formulation on Aspergillus Niger, a black mold that can lead to life-threatening health problems such as allergic reactions and pulmonary infections. Aspergillus Niger is known for being difficult to eradicate. In the study, Ygiene eliminated approximately 2.5 million spores of Aspergillus Niger within 2 minutes.

Dr. Andy Kielbania, BioNeutral’s Chief Science Officer, stated in a press release, “These results are particularly important because they both validate our internal lab testing protocols and also confirm the speed, efficacy and power of our Ygiene antimicrobials.” The company is confident that Ygiene can kill antibiotic-resistant bacteria such as MRSA, and aggressive viruses such as the H1NI “swine flu” virus. BioNeutral has been swamped with inquiries from China and India about Ygiene’s potential to kill H1N1. In May, the company announced plans to expand into Asia. 

The market for products that kill toxic mold is estimated to be $2-$3 billion annually.

Related post: BioNeutral Ships Mold-Fighting Ogeine-M Formulation

The Prostate Px+ test analyzes tumor biopsy samples to predict patient outcome at the time of diagnosis, helping physicians make more informed treatment decisions. According to Aureon CEO Vijay Aggarwal, the Px+ system is “a first application of this type of technology to personalized medicine.”

Today, more than 85% of all newly diagnosed patients are considered low- or intermediate-risk by American Urological Association guidelines.  Noteworthy is the fact that two patients in the same risk group, with similar clinical features, can have very different outcomes.  For this reason, it is important for patients to understand as much about their disease as possible.  Knowing their individual risk allows patients, with their physicians, to make more informed treatment decisions. Prostate cancer, which is the most commonly diagnosed non-skin cancer among men, kills approximately 29,000 men each year.

“We are very excited about this article because it provides important peer-reviewed credibility for our biopsy-based test,” says Aggarwal. Aureon Laboratories of Yonkers, NY, develops predictive clinical tests for cancer care.

Related video:  Dr. Vijay Aggarwal, CEO of Aureon Laboratories, discusses the Journal of Urology peer review.

The industry is now moving toward developing needle-free transdermal continuous glucose monitoring (tCGM) systems that increase patient compliance and allow patients to better monitor their diabetes—an innovation that Dr. Patrick Mooney, CEO of Echo Therapeutics (ECTE), calls the “Holy Grail” of diabetes management. Echo Therapeutics of Franklin, Mass., has developed the Symphony tCGM System, a needle-free, wireless system that allows patients to painlessly and accurately monitor their blood glucose levels around the clock. The Symphony System incorporates a patented feedback mechanism for optimal skin permeation control and a non-invasive, continuous transdermal glucose biosensor. The skin permeation device, called Prelude, removes the outermost layer of skin painlessly in approximately three to five seconds, allowing the biosensor to read glucose levels through the remaining layers of skin.

Prelude can also be used for transdermal drug delivery. Last month, Echo signed a license agreement with Ferndale Pharma Group that allows Ferndale to distribute the Prelude Skin Prep System for needle-free preparation of the skin prior to the application of topical 4% lidocaine cream for patients undergoing medical procedures. Prelude can deliver lidocaine in approximately 2 minutes, compared to 30 minutes for Ferndale’s method.

Echo recently announced its second deal in less than three weeks. The company has signed a license agreement with Handok Pharmaceuticals, the largest diabetes care-focused pharmaceutical company in South Korea. Both companies believe that the agreement will allow for significant opportunities in South Korea’s rapidly expanding glucose-monitoring market.

Echo believes that it will gain its first FDA approval next year in the hospital critical care market, which will allow the company to be “first-to-market” in hospitals with a needle-free continuous glucose monitor. 

Dr. Mooney is optimistic about the future of Echo Therapeutics and the Symphony System, which has undergone six positive clinical trials. He believes that the recent agreements validate what Echo is doing in the way of transdermal drug delivery and glucose measurement. “There is clear traction with the technology,” Mooney says.

The three proteins identified in the study (TLR 3, TLR 7, and TLR 9) reside in a part of the cell called the endolysosome. They detect the DNA and RNA of attacking pathogens, and then stimulate the immune system to produce antibodies. But these proteins can malfunction, causing the immune system to mark its own DNA and RNA as a foreign invader. The most common type of antibodies found in lupus are coded to attack the patient’s own genetic material.

The three TLRs are produced elsewhere inside the cell before being transported to the endolysosome. By switching off the gene that carries the three proteins to the endolysosome, scientists were able to prevent lupus from developing in laboratory mice. This suggests that the TLRs and the transport gene may be central to future lupus therapies. The research team will need to do more testing before developing a treatment for human use.

Several companies are already developing treatments for lupus, which affects approximately 1.5 million people in the U.S. Companies working in this area include Genelabs Technologies, Human Genome Sciences, Watson Pharmaceuticals, VLST Corporation, and La Jolla Pharmaceutical Company.

Related post: Positive Results for Human Genome’s Lupus Drug Benlysta

The merger could potentially improve circumstances for CombinatoRx. The Cambridge, Mass., company’s stock dropped after its lead drug candidate, Synavive, failed to meet its goal in a Phase II trial earlier this year. In an attempt to cut costs, the company laid off half its staff and slashed its R&D budget.

The merger with Neuromed marks the second deal CombinatoRx has struck in recent months. In May, the company agreed to collaborate with Novartis to discover novel anti-cancer compounds.

Cynosure, a manufacturer of lasers and light sources for medical and aesthetic use, has signed an agreement with Unilever to develop and commercialize light-based devices for home use. The multi-year agreement will focus on the skin rejuvenation segment of the marketplace, which aims to combat age-related wrinkles and lines. Unilever owns a number of popular home skincare brands, including Dove and Ponds. Westford, Mass.-based Cynosure hopes to leverage Unilever’s marketing and distribution capabilities to successfully introduce light-based devices into the home use market. Cynosure’s light-based systems are already used by medical and aesthetic professionals for such procedures as laser hair removal, scar reduction, removal of pigmented and vascular lesions, and skin rejuvenation.

A report published in March by Brocair Partners predicted that the U.S. market for energy-based aesthetic devices will exceed $1 billion by 2011. Companies working in this space include Eleme Medical, Lumenis, Photo Therapeutics, Cutera, and Diomed Holdings.

AST of New Haven, Conn., voluntarily suspended enrollment in an IDE trial last year following three reports of screw fracture. The company collaborated with an engineering firm to solve the problem, and the reworked screws performed significantly better in testing. 

The multi-center clinical trial will compare posterior dynamic stabilization in Stabilimax NZ and traditional spinal fusion surgery in patients with lumbar spinal stenosis.  In spinal stenosis, degeneration in the lumbar spine leads to a narrowing of the spinal canal. This narrowing leads to compression of the nerve roots, causing pain. It is estimated that half a million Americans may suffer from lumbar spinal stenosis.

Other companies developing solutions for degenerative spinal diseases include N Spine, Disc Motion Technologies, Interventional Spine, Spinal Kinetics, and AxioMed Spine.

Comprised of purified bovine serum albumin (BSA) and glutaraldehyde, BioGlue controls bleeding by creating a flexible seal upon its application to the tissue repair site. It is approved for use in the U.S. as an adjunct to sutures and staples in surgical repair, and is used primarily in cardiovascular and vascular surgeries. It is also used in the international market as an adjunct to surgical repair for soft tissues. CryoLife’s competitors in the adhesive market include Haemacure, Nerites Corporation, and MedLogic Global.  

CryoLife, based in Kennesaw, GA, has also developed a plant-based powder to control surgical bleeding. HemoStase quickly dehydrates blood and promotes clotting on contact. CryoLife began distributing HemoStase in the U.S. in the second quarter of 2008.