PROSTATE CANCER: CELL GENESYS ENTERS $320M GLOBAL ALLIANCE WITH TAKEDA FOR IMMUNOTHERAPY
South San Francisco, California-based Cell Genesys and Osaka, Japan-based Takeda Pharmaceutical said they formed a global alliance for the development and commercialization of GVAX immunotherapy for prostate cancer, Cell Genesys' lead product candidate. GVAX, currently in late-stage clinical development, is being developed as a non-patient-specific, off-the-shelf pharmaceutical product. The immunotherapy consists of tumor antigens and is designed to stimulate an immune response against the patient's tumor. Under the agreement, in exchange for exclusive worldwide commercial rights to GVAX immunotherapy for prostate cancer, Takeda will pay Cell Genesys an upfront payment of $50 million and additional milestone payments totaling up to $270 million relating to regulatory approval and commercialization of GVAX immunotherapy for prostate cancer in the United States, European Union, and Japan. Takeda will pay Cell Genesys tiered, double-digit royalties based on net sales of GVAX immunotherapy for prostate cancer in the United States and flat double-digit royalties based on net sales of the product in all other regions. Cell Genesys will maintain responsibility for the worldwide manufacture and supply of the product and will retain rights to co-promote GVAX immunotherapy for prostate cancer in the United States.

DIABETES: ENTELOS GETS PATENT ON VIRTUAL PATIENT MODEL OF DISEASE
Foster City, California-based Entelos said that the U.S. Patent and Trademark Office has granted it a patent on its computer model for diabetes. The company said the predictive computer model can simulate diabetic patients and drug effects and is used to select the most effective compounds, find the best doses, and support clinical trial design. The patent relates to the mathematical and computer modeling of multiple biological processes underlying the company’s metabolism platform, which can be applied to obesity as well as diabetes research. Entelos said it has already been used successfully with multiple pharmaceutical partners to select compounds to develop as treatments for diabetes, find the best doses for clinical trials, identify biomarkers, and characterize patient subtypes most responsive to certain drugs and drug combinations.

 

HODGKIN LYMPHOMA: STUDY OF TWINS OFFERS CLUE WHY DISEASE AFFECTS SOME AND NOT OTHERS
University of Southern California researchers said a long-term study suggests potential links between Hodgkin lymphoma and levels of the immune-response protein interleukin-12. The study, published in the journal Blood, found that lower levels of the protein interleukin-12, involved in fighting intracellular infections, increases susceptibility to young adult Hodgkin lymphoma. Hodgkin lymphoma is the most common type of cancer among young women and the second most common type among young men. The work is based on patient populations found in the International Twin Study and California Twin Program, unique registries of twin pairs developed and maintained in the Department of Preventive Medicine at USC. The researchers said the study, along with a previous one they published in 2007, provides the first clear evidence that individual differences in immune response may lead to the development of Hodgkin lymphoma.

 

A combination of experimental and computational protocols developed at the University of California at San Diego allows researchers to quickly and inexpensively determine the structure of unknown natural compounds, a development that can end a bottleneck in drug discovery. The work, presented at RECOMB 2008 (Research in Computational Molecular Biology) in Singapore, provides a way to cut the time it takes to determine the structure of peptides derived from natural compounds from six months or a year to as little as one day. The researchers said this advance may assist drug discovery researchers—who need to know as much as possible as quickly as possible about the natural products (which may have antibiotic, antiviral, or other pharmacologically interesting properties) that they are probing. Nonribosomal peptides, or NRPs, such as penicillin, and other natural products have an unparalleled track record in pharmacology: nine out of the top 20 best-selling drugs were either inspired by or derived from natural products. But it is currently difficult, time-consuming, and costly to determine the molecular structure of NRPs, the researchers said.  

MOLECULAR IMAGING: RESEARCHERS DEVELOP TOOL 1,000 TIMES MORE POWERFUL THAN CONVENTIONAL METHODS
A team of Stanford University School of Medicine researchers has developed a new type of imaging system that can illuminate tumors in living subjects, getting pictures with a precision of nearly one-trillionth of a meter. This technique, called Raman spectroscopy, expands the available toolbox for the field of molecular imaging. In an online article in the journal Proceedings of the National Academy of Sciences, the researchers describe how for the first time Raman spectroscopy has been used to image deep within the body, using tiny nanoparticles injected into the body. When laser light is beamed from a source outside the body, these specialized particles emit signals that can be measured and converted into a visible indicator of their location in the body. To see the nanoparticles, the researchers used a special microscope that they had adapted to view anesthetized mice exposed to laser light. The researchers could see that the nanoparticles migrated to the liver, where they were processed for excretion. Using a microscope they modified to detect Raman nanoparticles, the team was able to see targets on a scale 1,000 times smaller than what is now obtainable by the most precise fluorescence imaging using quantum dots.

 

NANOTECHNOLOGY: RESEARCHERS DESIGN NANOMACHINE THAT KILLS CANCER CELLS
Researchers from the Nano Machine Center at the California NanoSystems Institute at the University of California at Los Angeles have developed a novel type of nanomachine that can capture and store anti-cancer drugs inside tiny pores and release them into cancer cells in response to light. The device, known as a "nanoimpeller," is the first light-powered nanomachine that operates inside a living cell, a development that has strong implications for cancer treatment, the researchers report in the online edition of nanoscience journal Small. Operation of the nanoimpeller was demonstrated using a variety of human cancer cells, including colon and pancreatic cancer cells. The nanoparticles were given to human cancer cells in vitro and taken up in the dark. When light was directed at the particles, the nanoimpeller mechanism took effect and released the contents. The researchers said their key achievement was gaining precise control of the amount of drugs that are released by controlling the light exposure. The nanoimpeller system may open a new avenue for drug delivery under external control at specific times and locations for phototherapy.

 

CERVICAL CANCER: GEN-PROBE BEGINS CLINICAL STUDY OF MOLECULAR TEST FOR HPV
San Diego-based Gen-Probe said it has begun a pivotal clinical trial of its investigational APTIMA assay to detect human papillomavirus, or HPV, which can cause cervical cancer. The investigational APTIMA HPV assay is an amplified nucleic acid test that detects 14 high-risk HPV types that are associated with cervical cancer by detecting the presence of two messenger RNAs (mRNAs), E6 and E7, which are made in higher amounts when HPV infections progress toward cervical cancer. The company said that targeting these mRNAs may more accurately identify women at higher risk of having or developing cervical cancer than competing assays that target HPV DNA. Detecting HPV DNA identifies women who are infected, but HPV infections are common and many resolve without causing cervical cancer. The company said it remains on track to introduce its APTIMA HPV assay as a CE-marked product in Europe in the second half of 2008.

OFF-LABEL DRUG USE: STANFORD RESERACHER BLASTS PROPOSED FDA GUIDELINES
Proposed guidelines from the U.S. Food and Drug Administration that would allow companies to market more drugs for unapproved uses are a step in the wrong direction, said a researcher from the Stanford University School of Medicine. In an editorial published in The New England Journal of Medicine, Randall Stafford, associate professor of medicine at the Stanford Prevention Research Center, criticized the draft guidelines, which are subject to public comment through April 21. They curtail the FDA's already limited authority over the marketing of drugs for off-label uses, Stafford said. The FDA approves drugs for specific purposes, but doctors can use drugs "off-label" for medical conditions not approved by the FDA. One of the proposed guidelines' major pitfalls, said Stafford, would be allowing drug manufacturers to skip obtaining approval for potentially lucrative drug uses. Instead, companies might seek approval only for a narrower use that's more easily and less expensively tested, and sponsor research on more commercially promising uses that are never evaluated by the FDA. In a 2006 examination of off-label prescribing of 160 common drugs, Stafford found that off-label use accounted for 21 percent of all prescriptions and 73 percent of these uses had little or no scientific support.

 

HERPES: NIH AWARDS GRANT FOR DNA VACCINE
San Diego-based Vical said that it has been awarded a two-year, $2-million Phase II Small Business Technology Transfer grant from the National Institutes of Health’s National Institute of Allergy and Infectious Diseases. The grant will fund the ongoing development of Vical's immunotherapeutic plasmid DNA vaccine against herpes simplex virus type 2, a sexually transmitted virus and the leading cause of genital herpes. The HSV-2 vaccine will also be evaluated with Vical's novel Vaxfectin adjuvant. The initial preclinical development activities covered by the grant will be conducted at the University of Washington School of Medicine and the University of Texas Medical Branch, both centers of excellence in herpes virus research. The $2-million grant supplements the $300,000 award to Vical in 2005 for the HSV-2 vaccine program under a Phase I STTR grant from the NIAID.