San Diego’s Halozyme Therapeutics Seeks Biotech Cure for Cellulite
Halozyme Therapeutics is working on a treatment that attacks cellulite at its source. The experimental remedy is an enzyme—recombinant human lysosomal protienase—that digests collagen, the main protein of connective tissue.
When injected into a dimple, the enzyme “snips” the connective fibers tugging on the skin. Once the fibers are snipped, the dimple is released and the contour of the skin is smoother.
Although the enzyme isn’t ready for human tests, it has shown promise in animal studies, CFO Kurt Gustafson says. “We have the smoothest, most beautiful looking pigs you have ever seen,” he told me recently. One worry, of course, is that Halozyme’s enzyme will destroy more collagen than necessary and the skin will become flaccid as it loses its connectivity to underlying tissue. Halozyme addresses this problem by leveraging the enzyme’s inherent affinity for acidic environments.
CIRM Committee Urges Improved Transparency
The Citizens Financial Accountability Oversight Committee (CFAOC) voted unanimously in favor of recommendations made by the Little Hoover Commission last year to improve transparency at the California Institute for Regenerative Medicine. The commission called for management and structural reforms, including improving efficiency in the way grants and loans are distributed. The CFAOC was formed as part of California's Stem Cell Research and Cures Initiative (Proposition 71) in 2004 to review the financial practices and performance of CIRM. The California Stem Cell Report, an independent blog run by a veteran journalist and dedicated to CIRM business, recently ran a post about the issue.
Biomedical Industry Maintains or Adds Jobs in Next Two years
The biomedical industry is one of the most recession-resilient sectors in California’s hard-hit economy and a critical driver of innovation, job growth and revenue that will help lead the state to economic recovery, according to a report by the California Healthcare Institute (CHI) and PricewaterhouseCoopers LLP (PwC). The report points to signs that the state’s biomedical industry is facing unprecedented challenges and that California’s biomedical leadership is being tested as other regions compete for biomedical research and manufacturing jobs.
As part of the report, in November 2009 California Healthcare Institute and PricewaterhouseCoopers commissioned a survey of 200 of the state’s leading biomedical employers about their outlook for the industry and the key challenges and opportunities it faces. Based on employment trends, the survey found that the sector is holding steady and positioned for future growth, but it remains to be seen how much of that growth will take place in California. You can read an analysis of some of the life science industry data, or view a PDF of the full report at the CHI website.
PTO to Adjust New Patents
The U.S. Patent and Trademark Office announced an interim procedure for holders of new patents to request an increase in patent term adjustments in light of the U.S. Court of Appeals for the Federal Circuit's ruling in Wyeth v. Kappos. The interim procedure is available for holders of patents issued prior to March 2 who request a recalculation no later than 180 days after the issue date.
Obama Signs Temporary SBIR/SBTT Extension
President Obama signed into law H.R. 4508, which temporarily extends the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (SBTT) programs through April 30. The programs were slated to expire on Jan. 31. This is the third extension of the programs since last summer, when the House and Senate passed separate full reauthorization bills. Congress has yet to agree on how to reconcile the two bills, including differences in SBIR eligibility for companies majority-owned by venture capital firms.
Gates Foundation Pledges $10B for Vaccines
The Bill & Melinda Gates Foundation will commit $10 billion over the next 10 years to research, develop and supply vaccines for the developing world. Grant recipients have not yet been determined.
Obama Requests More FDA, NIH Funds
President Obama's FY11 budget request, submitted to Congress Monday, includes increases for FDA, NIH, and comparative effectiveness research. It assumes enactment of healthcare reform similar to legislation passed by the Senate, but does not provide details of costs or revenues.
The administration is requesting increases in FDA's budgets for regulating human drugs and biologics of $19 million and $8.6 million, respectively, which will allow the agency to hire 66 new full-time employees. Increases in PDUFA payments will support hiring an additional 56 employees for drugs and biologics. The request also includes $5.7 million to develop science and regulatory policies for biosimilars, and $25 million for regulatory science.
For NIH, the president requested $32 billion, an increase of $1 billion over FY10. This includes doubling the Therapeutics for Rare and Neglected Diseases (TRND) program, a translational medicine initiative, to $51 million. The National Cancer Institute would receive a $163 million increase, to $5.2 billion, funding the start of 30 new drug trials in FY11, and doubling the number of novel compounds in clinical trials by 2016.
The request includes $286 million for comparative effectiveness research at the Agency for Healthcare Research and Quality.
San Diego’s aFraxis Studies Drug Candidates to Treat Fragile X Syndrome
Fragile X syndrome is the second leading cause of mental retardation, after Down syndrome. Caused by a defect on the X chromosome, the syndrome affects boys more frequently and severely than girls; one-third of men with Fragile X are autistic and have trouble with communication and social interaction.
There is no cure or specific medical treatment for the genetic condition—at least not yet. Drug companies large and small, spurred by recent discoveries in neuroscience, are now working on possible treatments.
Among the more intriguing companies to enter the hunt is aFraxis, a San Diego startup backed by Avalon Ventures. The company, led by Avalon partner Jay Lichter, is leveraging discoveries from the lab of Nobel laureate Susumu Tonegawa of MIT to develop a pill that might reduce or reverse the brain abnormalities and related behavioral symptoms of Fragile X.
BrainCells Inc. Maps Out Next Steps for Novel Depression Drug
BrainCells Inc. surprised the field of psychiatry last August, when a clinical trial showed that it could relieve symptoms of depression with an odd combination of an anxiety drug and a common dietary supplement. Six months later, the company is in the thick of plotting the next steps to turn this into a potential commercial hit.
In its provocative study of 142 patients, BrainCells showed that a low-dose generic buspirone, anti-anxiety med, and the dietary supplement melatonin were able to achieve “comparable” effectiveness to standard treatments, known as selective serotonin reuptake inhibitors, according to Mauricio Fava, the vice chair of psychiatry at Massachusetts General Hospital.
The data to support the BrainCells drug is potentially a big deal both scientifically and medically. The new drug is thought to have a completely different way of working than standard meds, by stimulating the growth of new neurons in the brain, what’s known as neurogenesis. The new mode of treatment could have a big impact on mental health, because an estimated 20 million people in the U.S. suffer from depression, the standard drugs don’t work for everybody, and they can cause side effects like weight gain and sexual dysfunction. The BrainCells combination drug didn’t show any side effects like that, so it might be an important new option for millions.
Local Company Works On Treatment For 'Superbug'
San Diego-based Optimer Pharmaceuticals was recently profiled by the Channel 10 News to discuss Fidaxomicin, their treatment for Clostridium difficile Infection (CDI), a highly contagious bacterial infection of the colon.
Barney & Barney Names Three New Principals
Paul Hering, Managing Principal / CEO of Barney & Barney LLC, one of the nation’s largest insurance brokerages, is pleased to announce that Catherine Botello, Marc Pannier and Steve Shea have been made Principals of the firm. All three have been key players in the expansion of their respective departments, according to Hering.
Catherine joined Barney & Barney in 2002 and became a Principal in 2010. With over 13 years in the insurance industry, Catherine has devoted her career at Barney & Barney to the Employee Benefits Division.
Steve joined the firm in 2002 and became a Principal in 2010. Prior to becoming Principal, he served as a Client Executive in Barney & Barney’s Commercial Department, responsible for account service and retention, new account development and growth of niche insurance programs.
Since joining the firm since 2006, Marc has been a key player in the establishment and expansion of the company’s Orange County office. His responsibilities include business development and management of large and middle-market benefits clients.
Researchers Create Innovative New Way to Screen Libraries of 10 Million or More Compounds
The search for new drug compounds is probably worse than looking for a needle in a haystack because scientists are limited in the size of the haystacks they can rummage through—time and money make it virtually impossible to screen or search through super-large libraries of potential compounds. This is a serious problem, because there is enormous interest in identifying synthetic molecules that bind to proteins for applications in drug discovery, biology, and proteomics, and larger libraries should mean higher odds of success.
But large libraries come with large problems. Because even compounds with only modest affinity (binding to the target protein receptor with less force than those with high affinity) are usually marked as hits, researchers often end up with several hundred of them and, because of practical constraints involving time and money, no easy way to determine which might be the highest affinity or best compound to serve as a starting point to design a drug. These limitations and others have drastically blunted the use of very large libraries—monster libraries—in binding assays.
Professor Tom Kodadek at The Scripps Research Institute's Florida campus, and his colleagues at Scripps Florida and the University of Texas Southwestern Medical Center have devised an innovative new way to solve this longstanding problem. The new method displays millions of compounds on the surface of resin-based beads, each type of compound on a different bead. Kodadek said that he thinks the “method can revolutionize medicinal chemistry” but it is only the first step.
Team Maps Epigenome of Human Stem Cells During Development
Scientists at The Scripps Research Institute and The Genome Institute of Singapore (GIS) led an international effort to build a map that shows in detail how the human genome is modified during embryonic development. This detailed mapping is a significant move towards the success of targeted differentiation of stem cells into specific organs, which is a crucial consideration for stem cell therapy.
Chia-Lin Wei, who is senior group leader at the GIS, a biomedical research institute of the Agency for Science, Technology, and Research (A*STAR), said, "In this study, we mapped a major component of the epigenome, DNA methylation, for the entire sequence of human DNA, and went further by comparing three types of cells that represented three stages of human development: human embryonic stem cells, human embryonic stem cells that were differentiated into skin-like cells, and cells derived from skin. With these comprehensive DNA methylome maps, scientists now have a blueprint of key epigenetic signatures associated with differentiation."
Louise Laurent of Scripps Research and the University of California, San Diego, one of the first authors of the study, added, "The data are publicly available, and we are looking forward to learning what other scientists discover from using this information for their own studies on individual genes, embryonic development, and stem cells."
Scripps Research Team Reveals How An Old Drug Could Have A New Use for Treating River Blindness
Scientists at The Scripps Research Institute have discovered a potential new use for the drug closantel, currently the standard treatment for sheep and cattle infected with liver fluke. The new research suggests that the drug may be useful in combating river blindness, a tropical disease that is the world’s second leading infectious cause of blindness for humans.
River blindness is caused by thread-like filarial nematode worms, Onchocerca volvulus, which are transmitted among humans through the bite of a black fly. The nematodes then multiply and spread throughout the body. When they die, they cause a strong immune system response that can destroy surrounding tissue, including that of the eye. Currently, the only drug available for mass treatment of river blindness is ivermectin, and it now appears that resistance to that drug is emerging.
The new research shows that clostanel has the potential to inhibit the molting process of the parasite that causes the disease.
Scripps Research Scientists Find Two Compounds that Lay the Foundation for a New Class of AIDS Drug
A team of scientists at The Scripps Research Institute has identified two compounds that act on novel binding sites for an enzyme used by the human immunodeficiency virus (HIV), the virus that causes AIDS. The discovery lays the foundation for the development of a new class of anti-HIV drugs to enhance existing therapies, treat drug-resistant strains of the disease, and slow the evolution of drug resistance in the virus.
The anti-HIV compounds identified in the new study bind to HIV protease—an enzyme essential to the lifecycle of the virus. Drugs that block this viral enzyme are called “protease inhibitors” and currently make up an important part of the successful AIDS drug cocktail known as highly active anti-retroviral therapy (HAART).
Compared with the nine U.S. Food and Drug Administration (FDA)-approved drugs that target HIV protease, however, the two new compounds, which are small chemical units or “fragments,” bind with two novel parts of the molecule. This could make future drugs incorporating the fragments’ novel structural elements a useful complement to existing treatments.
Dash for Diet Drug
For decades, the pharmaceutical industry has chased an elusive target, a drug that will make you lose weight without putting your health at risk. Now, three California biotechnology companies are trying to convince the U.S. Food and Drug Administration that they’ve found drugs that are effective and safe. Not only that, they say the drugs can help with conditions that often accompany obesity, such as high cholesterol or blood pressure.
Of the three drugs, the only truly new one comes from Arena. Its approach was to design a drug, known as lorcaserin, that would hit the same molecular “receptor” the fenfluramine component of Fen-phen targeted for weight loss, without hitting other receptors that caused side effects.
The other two companies have combination drugs. Orexigen’s Contrave combines the antidepressant Wellbutrin, known generically as bupropion, with a sustained-release version of naltrexone, which is used to treat alcoholism and other addictions. Vivus’ Qnexa combines a generic form of the appetite suppressant phentermine, the other component of Fen-phen, with the anticonvulsant drug topiramate.
Emergence of “Femtomedicine” Reported at First Global Congress on Nano Medicine
Bombarding DNA nucleotides and mammalian tissue with ‘femto-neutrons’ has opened up the path to femtomedicine, an entirely new cancer diagnostics, it was reported today at First Global Congress on NanoEngineering for Medicine and Biology in Houston TX. Femto-neutrons or ‘femtons’ are fast neutrons of femto-meter wave-length, a million times shorter than the current nanotechnology diagnostic probes which operate on nanometer scale. In the first experiment of the kind, a collaboration of California Science & Engineering Corp. (CALSEC) and College of Medicine, University of California, Irvine (UCI), claimed that is was able to detect oxygen differences as tiny as 1 atom of oxygen per molecule. Since ‘hypoxic’ cancerous tumors contain 50% to 90% less oxygen than healthy tissue, if you find an oxygen difference between a tumor and the adjacent normal tissue – you have diagnosed cancer! The principle is named ‘Differential Femto Oximetry’ and the patented diagnostic probe ‘Oncosensor’. “We are ready and eager to test this interesting approach in vivo by making animals inhale carbogen, an oxygen enriched harmless gas”, said co-author Orhan Nalcioglu, Professor and Director of the Center for Functional Onco Imaging of the UCI College of Medicine.
To read more of the paper, or see 5 minute segments about CALSEC go to the company’s website www.calseco.com.
Sanford-Burnham Institute Offers Scientists a Symposium on Rare Diseases
The First “Burnham Symposium on Rare Diseases: Collaborations That Drive Discovery, Therapy, and Advocacy” will be held at Sanford-Burnham Institute for Medical Research in the Building 12 Auditorium Friday, February 26th. It will be an all day event with the start time still to be determined. Areas of discussion include bone diseases, congenital disorders of glycosylation, muscles disorders and more. For FREE registration and more information go to the institute’s website at www.burnham.org/rsvp.