Scientists at the Scripps Research Institute have discovered the biological trigger for the autoimmune disease lupus. Researchers identified three proteins, called Toll-Like Receptors (TLRs), that can cause the immune system to turn against the body. The study was published June 29 in the Early Edition of the Proceedings of the National Academy of Sciences (PNAS).

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

3 July 2009 | Blog, feature2 | vanderson | No Comments

CombinatoRx has signed an all-stock merger agreement with Neuromed, a privately held Canadian biopharmaceutical company. Under the new agreement, CombinatoRx will issue approximately 36 million new shares of its stock to Neuromed stockholders. Each company will initially hold 50 percent of the merged organization. That number will be adjusted depending upon the outcome of the FDA’s review of Exalgo, an opioid drug to treat chronic pain. Neuromed recently sold U.S. rights to Exalgo to Covidien subsidary Mallinckrodt. If Exalgo is approved by December 31, CombinatoRx shareholders will own 30 percent of the combined company. Their ownership stake will jump to 70 percent if Exalgo is not approved by the end of 2010. Exalgo is poised to become the first long-acting form of hydromorphone available in the U.S.

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.

2 July 2009 | Blog, feature2 | vanderson | No Comments

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.

2 July 2009 | Blog, feature2 | vanderson | No Comments

Applied Spine Technologies, a device company dedicated to the treatment of chronic low back pain, has received permission from the U.S. Food and Drug Administration to restart a clinical trial of the Stabilimax NZ Dynamic Spine Stabilization System. The Stabilimax system is designed to stabilize the lumbar spine while still preserving motion.

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.

1 July 2009 | Blog, feature2 | vanderson | No Comments

CryoLife, which specializes in implantable biological devices and surgical adhesives, announced that, according to company data, CryoLife’s BioGlue Surgical Adhesive has been used in more than 500,000 surgical procedures worldwide since its introduction in 1998. 

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.

30 June 2009 | Blog, feature2 | vanderson | No Comments

Aureon Laboratories, a developer of predictive tests for cancer care, has been featured in a cable television segment produced by the Yonkers Chamber of Commerce.

This Week In Yonkers: Business Spotlight highlights Aureon’s efforts to develop a more accurate predictive test for prostate cancer. In the 15-minute segment, CEO Vijay Aggarwal discusses the principles behind Aureon’s Prostate Px+ system. The test uses advanced image analysis technology to assess the severity of the disease and predict its progression, allowing physicians to make more effective treatment decisions. Director of Laboratories Charles J. DiComo gives viewers a behind-the-scenes overview of Aureon’s testing process. Aureon’s system is intended to be a more accurate alternative to the common PSA test. Two recent studies cast doubt on the PSA test, finding that it saved few lives and caused large numbers of men to undergo unnecessary treatment. According to the American Cancer Society, about 192,280 men in the U.S. will be diagnosed with prostate cancer in 2009.

The Yonkers Chamber of Commerce is the city’s largest business association, acting to promote economic development and the creation of job opportunities within Yonkers. Aggarwal is pleased with Aureon’s location in the i.Park, a research park housing a collection of businesses and technological innovators. He says that the company’s location in Yonkers grants Aureon access to both financial and intellectual capital.

For more information about Aureon, view the company profile video on the OneMedPlace homepage.

Related video: This Week In Yonkers: Business Spotlight

29 June 2009 | Blog, Member Spotlight, Video, feature1 | Melanie McFarland | No Comments

Safeguard Scientifics, a Pennsylvania-based investor in information technology and life sciences companies, announced that its portfolio company Clarient has filed a registration statement with the Securities and Exchange Commission on Form S-3 relating to shares of Clarient owned by Safeguard. Safeguard President and CEO Peter J. Boni says that the filing replaces a registration statement that expired last February. Although the filing would give Safeguard the right to sell Clarient stock publicly when the registration takes effect, Boni stated that Safeguard does not intend to trickle out shares of Clarient into the market. Safeguard owns 47 percent of Clarient’s stock. The market value of Safeguard’s position in Clarient was $169 million as of June 19, compared to $76 million at the end of last year.

Clarient, based in Aliso Viejo, Calif., provides comprehensive anatomic pathology and molecular testing services. The company recently launched a new gene mutation test for non-small cell lung cancer, the most common form of lung cancer.

Related post: Clarient Deal Frees Up Cash for Safeguard Scientifics

26 June 2009 | Blog, Member Spotlight, Sentinel 2, feature2 | Melanie McFarland | No Comments

SyntheMed, a biomaterials company engaged in the development and commercialization of anti-adhesion products, has been nominated for the prestigious Frost & Sullivan Health Innovation Award in pediatrics. The Iselin, NJ-based company was recognized for its REPEL-CV Anti-Adhesion Barrier, a thin film designed to be placed over the heart at the conclusion of open-heart surgery to reduce the formation of post-surgical adhesions. REPEL-CV is approved by the U.S. Food and Drug Administration for use in pediatric cardiac surgery. The Frost & Sullivan Health Innovation Award is presented annually to a medical device company demonstrating innovation in new product development.

Related post: SyntheMed’s REPEL-CV Approved by Australian Regulators

25 June 2009 | Blog, Member Spotlight, Sentinel 2, feature2 | Melanie McFarland | No Comments

CNS Response announced that it has closed a $1 million bridge loan with venture capitalist John Pappajohn. Pappajohn has been involved in over 100 startups, including Caremark and Quantum Health. Over the past two months, CNS Response has closed two bridge loans totaling $1.2 million.

The money will allow CNS Response, based in Costa Mesa, Calif., to complete an upcoming depression study. The company has completed enrollment at 14 sites for a treatment-resistant depression clinical trial. CNS Response is now on track to complete the study by September, with results to be released before the end of 2009.

CNS Response is positioning its Referenced-EEG (rEEG) system as a cost-saving, more clinically effective approach to treating depression. A 2004 study published in PharmacoEconomics found that patients with treatment-resistant depression spend almost twice as much on doctor visits and outpatient claims than regular patients. Many depression patients try one medication after another, spending money and time, in an often futile effort to find something that works. CNS Response notes that treatment failure in disorders like depression ranges from 40 to 60 percent. REEG is a system of physiologic markers used to guide physicians in the treatment of patients with mental illness.  Certain biomarkers predict the probable effectiveness of specific drugs.  The rEEG system analyzes these biomarkers and compares them to a clinical database to detect abnormal patient physiology, helping physicians to prescribe medications with the highest potential effectiveness.

In an earlier series of clinical trials involving patients with treatment-resistant depression, physicians helped over 75 percent of them find medications that worked. A study released last year by United BioSource, a global pharmacoeconomic research firm, indicated that the use of CNS Response’s rEEG system for treatment-resistant depression is “superior to the American Psychiatric Association treatment guidelines.”

25 June 2009 | Blog, Member Spotlight, Sentinel 1, feature2 | Melanie McFarland | 1 Comment

Kowa Pharmaceuticals America announced that the U.S. Food and Drug Administration has approved Cambia for the treatment of acute migraine headaches in adults. Cambia is a diclofenac-based non-steroidal anti-inflammatory drug (NSAID) combined with potassium bicarbonate. In clinical trials, Cambia not only treated migraine pain, but also the associated symptoms of sensitivity to light, sensitivity to sound, and nausea. The drug provided statistically significant onset of relief of migraine pain within 15 to 30 minutes.

Cambia is designed to fill the large, unmet clinical need for a fast-acting migraine treatment. According to the U.S. Department of Health and Human Services, migraine pain and symptoms affect approximately 29.5 million Americans. In a recent peer-reviewed publication authored by migraine researchers, 70 percent of patients indicated they were unsatisfied with their current treatment. Cambia is approved to treat migraines with or without auras. Patients with auras may see flashing lights, feel numbness in the extremities, or experience sensory disturbances. One in five migraine patients experiences an aura.

Alabama-based KPA is owned by the Kowa Company, a multinational company headquartered in Japan. Other companies developing migraine pain treatments include NatureWell, Vernalis Pharmaceuticals, NeuraLieve, POZEN, and Winston Laboratories.

24 June 2009 | Blog, Sentinel 2, Uncategorized, feature2 | Melanie McFarland | No Comments