San Diego Breakthroughs
by Lois Alter Mark

Over the past few years, San Diego has become one of the top biotech clusters in the world, home to such prestigious research facilities as The Salk Institute, Scripps Research Institute, UCSD, The Burnham Institute, and more than 500 life-science companies.

With such a wealth of scientific resources, San Diego is considered a medical research powerhouse. According to Joe Panetta, president and chief executive officer of BIOCOM, the association representing Southern California’s life science community, more than 75 products geared toward improving people’s health and well-being are in the phase II and phase III pipeline in San Diego.
These are just a few local breakthroughs.

Ophthonix
If we can have high definition TV, shouldn’t we be able to have high definition eyesight? We can, according to San Diego-based Ophthonix. The company is revolutionizing the industry with a comprehensive vision correction system that uses the latest wavefront technology to examine the eye objectively, provide a complete vision correction prescription, and even manufacture the lens.

The company’s Z-View Aberrometer is a low-power laser beam that maps the eye, measuring more than 11,000 points of resolution and creating a prescription that mirrors the patient’s unique optic “fingerprint.” The days of taking eye exams by trying to figure out whether lens two really looks clearer than lens one, and whether lens three looks even clearer than lens two, are over. No guesswork is involved as the laser reads the eye accurately and quickly.

“This is the first significant advancement in vision correction in 100 years,” says Dennis Jarvis, Ph.D., vice president of marketing. “Patients have told us it’s changed their lives.”

According to Jarvis, even people with 20/20 vision may have experienced problems with night driving in the past because of glare and “starbursts,” which traditional methods have not correctly identified. Now, these high order aberrations can be easily detected by the Z-View Aberrometer and corrected with the iZon Wavefront-Guided Lens, a high-tech breakthrough in which a patient’s prescription is digitally programmed into the lens in a process similar to burning a CD.

Ophthonix is looking to transform the industry with high-definition vision that will be superior to the current 20/20 benchmark. The company believes that its technology can eventually become the standard. San Diegans are among the first to experience the difference with more than two dozen practitioners in San Diego and Orange County already converting to the Ophthonix system. To find a practioner near you, check www.ophthonix.com.

Neurodex
For some people with certain neurological disorders such as Alzheimer’s, ALS, multiple sclerosis, stroke, and traumatic brain injury, the most difficult symptom to live with is not the underlying condition itself, but rather the emotional episodes that often accompany it. Many of these patients experience occurrences of uncontrollable crying and/or laughing that are not related to how they truly feel. The medical term for this is “pseudobulbar affect” (PBA). Medical experts believe that this syndrome is related to injuries in certain pathways of the brain that normally allow us to control emotional expression. Currently under recognized and under treated, PBA is currently is often misdiagnosed as depression.

Although PBA is not physically harmful, it can have significant effects on quality of life and relationships with others. Fear of having an emotional outburst in public often leads patients to become reclusive and avoid social situations altogether.

Avanir Pharmaceuticals in Sorrento Valley is developing a new drug specifically for PBA. The company began submission of a new drug application to the FDA in December. If all goes well, Neurodex will be the first product approved by the FDA for this indication.

“This will make a huge difference in the lives of people who suffer from PBA,” says Patrice Saxon, director of investor relations at Avanir. “Picture someone at a funeral suddenly laughing hysterically and uncontrollably. There’s no rhyme or reason for it, and the person knows he or she shouldn’t be doing it but just can’t stop it. This can happen at any time for a person who has PBA.”

Although this new therapy would not treat the underlying neurological conditions, Neurodex has the potential to greatly improve the quality of life of more than a million people, giving them the confidence to once again become active members of society.

For more information, log on to www.avanir.com.

Obesity And Diabetes
– Arena Pharmaceuticals

It’s no secret that obesity has become one of the country’s most important health concerns. Almost one-third of the U.S. population is considered obese, and another third could benefit from some weight loss. Yet no company has been able to come up with a product that successfully suppresses appetite without causing dangerous side effects.

Locally-based Arena Pharmaceuticals is hoping to come up with that product. The company expects to announce soon the results of phase II clinical trials of its most advanced product candidate – APD 356, which addresses the particular protein in the brain that regulates food, hunger, and metabolism.

Jack Lief, CEO of Arena Pharmaceuticals, says that side effects have historically limited the utility of weight loss drugs, pointing to fenfluramine and dexfenfluramine (commonly referred to as “fen-phen”). Although effective appetite suppressants, these drugs had to be taken off the market after reported incidences of heart valve disease and pulmonary hypertension associated with their usage.

“Unlike those [fenfluramine and dexfenfluramine], APD 356 is so selective, it should be able to avoid any cardiovascular side effects,” says Lief. “It’s a pretty unique compound that targets a specific receptor, suppressing hunger while at the same time maintaining metabolism.”

If clinical trial results are as successful as they’re expected to be, Arena hopes to make APD 356 available within five years.

And just last month, the FDA approved Byetta, a diabetes drug derived from the venom of a poisonous lizard and developed by San Diego-based Amylin Pharmaceuticals. This recent breakthrough has been successful in controlling the blood sugar levels of patients while also helping them lose weight.

The drawback to Byetta, though, is that it has to be injected twice daily. Arena is working on a pill that the company is hoping will put an end to injections for those who suffer from type II diabetes.

Last year, Arena partnered with Ortho-McNeil, the pharmaceutical arm of Johnson and Johnson. Although the drug is in the early stages of preclinical development, Jack Lief believes it has the potential to become the standard of care for patients with type II diabetes. Follow the news about these breakthroughs at www.arenapharm.com.