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San Diego-based Cytori Therapeutics said it received results from an independent, investigator-sponsored study in Japan in which adipose tissue-derived stem and regenerative cells were used for breast reconstruction following partial mastectomy. The study data were presented at the 30th San Antonio Breast Cancer Symposium. It evaluated the procedure in 21 women with no metastases or recurrence at least one year after partial mastectomy. The study found the procedure was safe and well tolerated in all women, and that there was no rejection or immune response observed. The company said the procedure holds the potential to offer women the opportunity to restore the contour, volume, and function lost during cancer treatment.

 

Los Angeles-based Xcorporeal said a prototype of its Wearable Artificial Kidney produced promising results in a pilot study, published in the journal Lancet. The device is a battery-powered, wearable dialysis machine that will allow users to have their blood cleansed round the clock instead of being tethered to conventional dialysis machines, intermittently, for many hours. The study, conducted by researchers at the Royal Free and University College Hospital Medical School, London, U.K., showed that the artificial kidney’s clearance rate, if sustained and used continuously, could be more effective than conventional three times weekly or daily hemodialysis treatment. This proof-of-concept study also provided preliminary indications on the safety features of the artificial kidney and permitted the patient to be ambulatory during treatment.

 

HOSPITALS: DO NOT RESUCITATE ORDERS NEED STANDARDIZATION
Methods to identify a patient with a Do Not Resuscitate (DNR) order are incredibly varied across hospitals, ranging from written documentation practices to the use of color-coded wristbands, researchers at the University of California at San Francisco report. According to a new study in the Journal of Hospital Medicine, a national effort to standardize color-coded wristbands, likely around a few specific indications, would remove current practice variations and the associated potential for errors. There are currently no standards of color choice for hospitals using color-coded wristbands, and each hospital has a different set of colors for different indications. This lack of standardization creates the potential for errors. For example, some hospitals have used yellow to signify “Do Not Resuscitate,” leading to several near-misses with patients wearing yellow Lance Armstrong “Livestrong” bracelets. If a standard color choice existed for DNR orders, the potential for errors with either personal patient wristbands or those used by hospitals would be averted.

Scientists at International Stem Cell said they have created unique human stem cell lines that make them easily “immune matched” to human beings and could enable the creation of a bank of stem cells that could be used, without rejection, by a majority of the different people and races of the world. Akin to the concept of finding multiple “universal Type O blood donors,” the Oceanside, California-based company said the discovery is significant because it would eliminate the need for harsh immune suppression drugs currently used for cell transplant therapy. The finding, published in the online edition of Cloning and Stem Cells Journal, may open the door to cell transplant therapy for diseases such as juvenile diabetes where the use of immune suppressant drugs is harmful to the patient.

 

ANTIBODIES: SCRIPPS DISCOVERY LEADS TO PFIZER ACQUISITION
A catalytic antibody discovery made at The Scripps Research Institute in La Jolla, California has formed the basis of the upcoming acquisition of biotechnology venture CovX by pharmaceutical giant Pfizer. As licensor of the technology, Scripps Research will receive a percentage of the proceeds from the sale, as well as royalties from any resulting therapies. The transaction between CovX and Pfizer was announced by the companies on December 18 and is expected to be completed in the first quarter of 2008. The work offers a groundbreaking way to physically combine catalytic antibodies, which are large, soluble molecules that remain in the body for long periods of time, with small-molecule drugs and peptides, which can kill disease-causing cells but may be expelled from the body too quickly to be effective as a therapy. These hybrid molecules have the desirable properties of each—killing disease-causing cells and staying in circulation long enough to dramatically enhance the drug's effectiveness. The approach, which the scientists call "chemically programmed antibodies," has led to a number of compounds against cancer and metabolic disease under development by Dublin-based CovX.

 

The first clinical trial of a new kind of drug to cut the risk of cardiovascular disease has been found safe and effective at dropping levels of “bad” low-density lipoprotein cholesterol by as much as 40 percent. High LDL levels increase the risk for heart attack and stroke. Researchers at the Swedish pharmaceutical firm Karo Bio, which is developing the drug known as KB2115, said the drug mimics the action of thyroid hormone and safely accelerates the hormone’s natural ability to rid the body of LDL. It is unrelated in structure or action to statins, the widely used class of drugs to lower cholesterol, and may offer an alternative for patients who cannot tolerate statins, according to the research team. It might also complement the use of statins to further decrease cholesterol levels, the researchers from the company, the Karolinska Institutet in Sweden, and the University of California at San Francisco report online in The Proceedings of the National Academy of Sciences. In the clinical trial, the new drug was shown to lower LDL levels and promote the removal of cholesterol through the liver.

 

San Diego-based Ambrx said it has entered into a collaboration with Eli Lilly to discover and develop novel treatments in several therapeutic areas, including metabolic diseases, central nervous system disorders, and other diseases. The collaboration will apply Ambrx's protein optimization technology, ReCODE, with Lilly's expertise in biologics discovery, development, and commercialization to pursue first-in-class or best-in-class drug candidates, including therapeutic antibodies and improved variants of native proteins. Under the terms of the agreement, Ambrx will receive an initial upfront payment and ongoing research support payments. Ambrx may also receive potential research and development milestones, and, if assets resulting from the collaboration are successfully commercialized, Ambrx would receive additional milestones and royalties. Other terms of the deal were not disclosed. This collaboration builds on an earlier agreement signed between the two companies in January 2007.

 

SICKLE CELL: ANTHERA GETS ORPHAN DRUG STATUS FOR ACUTE CHEST SYNDROME  
The U.S. Food and Drug Administration granted orphan drug status to San Mateo, California-based Anthera for A-001, a drug in development for the prevention of acute chest syndrome caused by obstruction or infection in the lungs of patients with sickle cell disease. A-001 is currently being evaluated in a mid-stage clinical trial for acute chest syndrome. Orphan drug designation grants special status to promising new therapies that treat conditions affecting fewer than 200,000 patients in the United States and entitles seven years of market exclusivity. Additionally, the sponsor of the product is offered incentives which include eligibility for research grants, certain tax benefits, protocol assistance, and possible exemptions or reductions of certain regulatory fees during development or at time of market approval. In addition to orphan drug designation, the FDA has granted Anthera expanded enrollment of its clinical trial to include patients as young as five years of age. Acute chest syndrome primarily affects children suffering from sickle cell disease. It is believed that the incidence of sickle cell disease is highest in children two to four years of age, decreasing gradually to its lowest value in adults.

 

San Carlos, California-based Nektar Therapeutics said it extended its agreement with subsidiaries of Baxter International to develop new PEGylated therapeutics for hemophilia. PEGylation is a means of using a polymer to extend how long a molecule remains in the body and is used to reduce the frequency of dosing. The program will begin pre-clinical development in 2008. This is the second agreement between Nektar and Baxter to work together on therapeutics for hemophilia patients. The two companies announced their initial agreement in September 2005 to develop PEGylated therapeutic forms of clotting proteins to treat hemophilia A. Under the terms of the expanded agreement, Nektar will receive up to $44 million in upfront and milestone payments, funding of research and development, and manufacturing revenues during research, clinical development, and commercialization. Nektar will also receive royalties on end product sales. Baxter will be responsible for the development and commercialization of the product, and Nektar will be responsible for the development of technology used in the product, including the provision of clinical and commercial PEG reagents. Nektar PEGylation technology has already been successfully applied to eight marketed products in the United States and Europe.

 

Alameda, California-based InSite Vision said it has initiated pivotal late-stage clinical trials to evaluate AzaSite Plus for the treatment of blepharoconjunctivitis, a frequently chronic inflammation of the conjunctiva and eyelids caused by infections or allergic reactions. AzaSite Plus, formulated in InSite’s patented DuraSite-sustained delivery vehicle, is a topical combination antibiotic/corticosteroid product that is being developed to provide simultaneous antimicrobial and anti-inflammatory treatments. Blepharoconjunctivitis is a disease with no approved drug therapy indicated for the relief of its chronic symptoms.