Emory University is one of the nation’s leading private research universities and a member of the Association of American Universities. Known for its demanding academics, outstanding undergraduate college of arts and sciences, highly ranked professional schools, and stateof- the-art research facilities, Emory is ranked as one of the country’s top 20 national universities by U.S. News & World Report. In addition to its nine schools, the university encompasses The Carter Center, Yerkes National Primate Research Center and Emory Healthcare, Georgia’s largest and most comprehensive health care system. Emory’s technology transfer success, in the life sciences area alone, includes eight licensed products with market approval for the treatment of HIV and an additional nine potential therapeutics in various stages of clinical development by its licensees.
Featured Startups and Technologies
Angioplasty has come a long way. In the early days of the procedure, stainless steel stents were used to keep the patient’s artery from reclosing after the angioplasty balloon restored blood flow. But about a fifth of these patients developed restenosis – the growth of scar tissue in and around the stent. The results were chest pain, repeat procedures to reopen the clogged artery, and sometimes death from heart attack. To remedy this situation, in the late 1990s Emory University physician/scientists Ian Crocker, Spencer King, Keith Robinson, and Ron Waksman, along with engineers from Novoste Corporation, developed the Beta-Cath System, which uses vascular brachytherapy to prevent the artery from re-closing. With brachytherapy, tiny “seeds” of radiation are placed within the coronary artery at the site of the angioplasty, and are left in the artery for less than five minutes before being removed. The radioactive seeds minimize the growth of cells at the site, which reduces the amount of scar tissue that may develop. Patients’ exposure is less than 1 percent of the radiation they would be exposed to by a typical chest X-ray. The Beta-Cath System was licensed to Novoste and received FDA approval in 2000. It was the first commercially available vascular brachytherapy device in the U.S. and Europe. A few years later, Novoste received FDA approval for its smaller diameter Beta-CathTM 3.5F System and its Beta-CathTM System that uses a 60mm radiation source. The company also began clinical trials of its CORONATM System for treatment of peripheral vascular disease and restenosis of arterial-venous dialysis grafts. In 2006, Novoste (now NOVT) sold all of its vascular brachytherapy assets to Best Vascular, Inc. What sets Beta-Cath apart from other new technology, such as drug-eluting stents, is its proven track record. When standard stainless steel stents are used, 15 to 20 percent of patients experience restenosis as well as bouts of angina and chest pain. Drug-eluting stents, which are coated with medicines that interfere with reblocking, show a complication rate of 8 percent, while Beta-Cath has shown complication rates as low as 3.8 percent. Fewer procedures mean less expense for the patient, less of a burden on the nation’s health care system, and longer and better lives for patients. Beta-Cath is backed by data and the experience of interventional cardiologists, who have used it to treat more than 50,000 patients worldwide.
Approximately one-third of individuals with hemophilia A develop an immune reaction (inhibitors) to hFVIII and can no longer respond to treatment with the coagulation factor. Current therapies, specifically FVIIa and FEIBA, work by bypassing the natural hemostatic pathway and driving coagulation by raising FVIIa and other activated coagulation factors to higher levels than normal. In contrast, OBI-1, a recombinant B-domain deleted FVIII bioengineered based on the porcine amino acid sequence that typically possesses low cross reactivity to anti-hFVIII antibodies, is a physiologic replacement therapy, activating the natural hemostatic pathway. This would allow clinicians to correlate activity and efficacy with a biomarker and therefore guide dosing and better predict treatment outcomes. OBI-1 presents a unique and alternative approach to address the needs of individuals who have developed inhibitors to FVIII and is highly desired by the medical and patient communities. OBI-1 has been evaluated in a Phase 2 study in patients with congenital hemophilia A who have developed inhibitors to FVIII and who presented with a non life/non limb threatening bleed. The Phase 2 study demonstrated OBI-1 was well-tolerated, stopped the bleeding in all subjects, and can be given over a short infusion time.
Traumatic brain injury (TBI) is a non-degenerative, non-congenital insult to the brain from an external mechanical force, possibly leading to permanent or temporary impairments of cognitive, physical and psychosocial functions with an associated diminished or altered state of consciousness. Approximately 1.5 million Americans per year suffer a traumatic brain injury, resulting in 50,000 deaths, 235,000 hospitalizations and 80,000 cases of long-term disability. Incidence of TBI in all industrialized countries is comparable to that in the U.S., with estimates ranging from 150 to more than 300 per 100,000. There are approximately 66,000 deaths annually attributed to TBI in Europe. The leading cause of TBI in the world is road traffic accidents, accounting for 40-50 percent of the hospitalizations for TBI. There are currently no approved medications to improve outcomes following TBI. A Phase III clinical study is underway that will build on promising results achieved in several previous clinical trials that demonstrated a mortality benefit and improved functional outcomes in TBI patients treated with progesterone.
NADPH oxidase inhibitor
Age-Related Macular Degeneration (AMD) is a degenerative eye disease that causes damage to the macula (central retina) of the eye and is the leading cause of blindness for people over the age of 55 years. AMD affects a person’s central vision by causing damage to the macula, the portion of the retina that allows for fine details in vision. AMD manifests itself in two forms, the “wet” form and the more common “dry” form. The “wet” form is caused by the growth of new blood vessels behind the macula. This can cause severe visual loss due to subsequent leakage and creation of scar tissue. Dry AMD accounts for up to 90 percent of all cases of AMD and causes a gradual thinning and loss of function of the macula. There is no drug approved for the treatment of dry AMD at this time. A large body of evidence continues to target oxidative stress as a key aspect in both disease development and progression. The increased levels of ROS, which result from oxidative stress, appear to contribute to certain pathologic conditions, including dry AMD. Therefore, reducing ROS levels is becoming an important therapeutic strategy to treat AMD as well as other ophthalmic and non-ophthalmic conditions. While antioxidant compounds attack existing ROS, an NADPH oxidase inhibitor reduces superoxide production and, subsequently, limits the formation of ROS. The NADPH complex has long been recognized as the source of superoxide in phagocytic cells; scientists, however, are starting to appreciate its presence in other cells. Animal studies based on models of disease states, including ocular disease states, are producing evidence of the therapeutic implications of inhibiting this enzyme complex.
AtheroGenics researches, develops and distributes drugs that treat chronic inflammatory illnesses, including coronary heart disease, asthma, organ transplant rejection and rheumatoid arthritis. The company owns a vascular protectant technology platform to aid the discovery of drugs. AtheroGenics developed a drug, AGI-1067, with the goal of helping control blood sugar levels in people with Type 2 diabetes.
GeoVax develops vaccines for diseases caused by HIV-1 (AIDS). The company aspires to distribute AIDS vaccines globally that undergo vigorous testing from both the FDA and international groups. GeoVax’s ultimate goal is to develop the world’s first AIDS vaccine. The vaccines combat diseases caused by the three major HIV subtypes (A, B and C), but their top priority is subtype B, which is most common in North America, Europe, Japan and Australia. The AIDS vaccines have been shown to provide immunity in non-human primates against multiple AIDS proteins. This suggests that GeoVax’s vaccines could provide protection against the development in people infected with the AIDS virus. GeoVax is currently conducting five clinical trials. After successful results from all phase 1 trials, phase 2A trials of the company’s product candidates began in January 2009. They involve 225 participants at sites in the United States and South America. Phase 2B trials, which will study in detail how safety and immunogenicity are scheduled to begin in 2011.
Pharmasset is a clinical-stage pharmaceutical company that discovers, develops and commercializes novel drugs to treat viral infections. Its primary focus is on the development of drugs for the treatment of the hepatitis C virus (“HCV”). The company currently has two product candidates that are close to being ready for clinical development. RG7-128, a drug designed to treat HCV, is entering a phase 2B clinical trial, which will test how a specific dosage of the drug affects patients. PSI-7977, currently in phase 1 trials to figure out the appropriate dosage, is a second-generation nucleotide analog that also treats HCV. The company is also seeking to develop Racivir for the treatment of HIV. Pharmasset’s research and development efforts focus on a class of compounds called nucleoside analogs. These inhibit the enzymes that are required for viral replication. They disrupt the copying of the virus’ RNA genome into a person’s DNA genome.
Triangle Pharmaceuticals / Gilead
Triangle Pharmaceuticals was a biopharmaceutical that developed solutions for serious viral diseases, with a particular focus on therapies for the human immunodeficiency virus (HIV), including the acquired immunodeficiency syndrome (AIDS) and the hepatitis B virus. The company developed a portfolio of antiviral drug candidates in advanced stages of development including Coviracil (emtricitabine) for HIV and HBV, amdoxovir for HIV and clevudine for HBV. Triangle also developed immunotherapies for HIV. In January 2003, Triangle Pharmaceuticals was acquired by Gilead Sciences, a leading antiviral biotechnology company. Gilead is also a research-based biopharmaceutical company with Gilead’s primary areas of focus include HIV/AIDS, liver disease and serious cardiovascular/metabolic and respiratory conditions. Its portfolio of 13 marketed products includes Atripla – the first single-tablet regimen for HIV infection and Viread – the company’s first agent approved for HIV infection, which was also approved in 2008 for the treatment of chronic hepatitis B. Gilead is a $42 billion public company and has operations on four continents.
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