Sue-The abstract was submitted
prior to Nowinski's putting an end to the cancer trials in Israel; therefore
at that time it was expected that 13 additional cancer patients would be
accrued. Since the cancer cachexia trials were halted at Nowinski's urging,
this is no longer true. There are no more cancer patients enrolled in
clinical trials in Israel or elsewhere.
The trials as originally conceived called for thirty AIDS patients (10 at each of the three dose levels) and fifteen cancer patients. We are now up to 23 completed AIDS patients and have terminated the cancer studies entirely with only the two pancreatic cancer patients completed.
I hope this answers your question.
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ADVR's ASCO presentation:
sparkr, I think you will agree with
me - the only event which will lend credibility and a sustained rising price
will be a partner.
Short of that (including even more great news and great results), this company will fail.
In the end, the "ALL news and results" MUST impress a potential partner - and no matter what YOU and I bicker over, without that positive impression - the future remains with another entity willing to stand at ADVR's side.
Without a partner, the road ahead is very bleak!
Biotech competition grows
As U.S. states strive for more involvement, foreign countries also showing more interest.
By Jim Hopkins
USA Today, June 9, 2004
SAN FRANCISCO -- More foreign countries are competing for biotech startups and investors just as U.S. states are pushing for a bigger slice of the same market.
About a third of more than 17,000 participants at the biotech industry's annual meeting this week are from outside the United States, up from a quarter last year. Some of the biggest growth is from Asian nations. They are likely to pose the biggest challenge to America's domination of biotech, according to a recent Ernst & Young study.
China, where scientists are working on four AIDS vaccines, expects 30 delegates at the meeting, compared with three last year. Japan will have 400, representing biotech firms, researchers and government, more than double last year's total.
The surge in foreign interest comes as biotech shows more promise. Global revenue jumped 13 percent to $47 billion last year from 2002. Losses plunged 64 percent to $4.5 billion. So states and regions -- including Central Indiana -- are vying for startups that will create anti-cancer drugs and high-paying jobs. Six governors, including Florida's Jeb Bush, are leading delegations at this year's Biotechnology Industry Organization meeting.
Some growth in foreign interest is because of the San Francisco venue, one of biotech's biggest hubs for companies and potential investors. That makes the area good hunting grounds to showcase:
• Cost advantages. Labor in China and India is cheaper. Companies pay scientists as little as 20 percent of what they would earn in the United States, says Ansbert Gadicke of MPM Group, a major biotech venture-capital firm planning more investments in Asia.
• Financial commitment. More Japanese investors are willing to fuel biotech startups even though they lose money, Ernst & Young said. India has agreed to let insurance companies invest in biotech venture funds. China's government is investing $1.3 billion in biotech from 2001 to 2003.
• Unfettered politics. Stem-cell research, limited by the Bush White House, faces fewer restrictions outside this country. South Korea this year became the first to clone a human embryo for stem cells to treat organ failure and other illnesses.
France passed laws encouraging university and other researchers to turn lab discoveries into money-making ventures, says Donny Strosberg, CEO of French biotech Hybrigenics.
Still, biotech won't be a slam-dunk for foreign nations. The bulk of venture-capital firms that fuel biotech startups is in the United States. The firms prefer to invest in ventures nearby because VCs meet frequently with senior managers. Moreover, "We think there is a bigger management pool in the U.S.," says Pat Latterell, founder of Latterell Venture Partners, which invests in early stage health care companies, including biotech.
BIO 2004 Conference in San
Biotechnology essential to medical progress
Jay A. Levy
Tuesday, June 8, 2004
This week's biotech gathering in San Francisco gives us an opportunity to highlight the advances in science and medicine that have resulted from biotechnological discoveries, and to encourage and anticipate progress.
A major objective of this field is to find solutions to medical problems using approaches that include: genetics (manipulating DNA and its RNA counterparts); protein chemistry (producing cellular products for treatment); and cellular therapy (injecting cells into people to resolve a loss or combat a disease).
With the last approach, human cells can be modified to better recognize infectious agents or inhibit the over-response of some components of the immune system that leads to autoimmune diseases such as lupus and rheumatoid arthritis.
The field of genetics benefited from the development of the polymerase chain reaction that enables amplification of tiny quantities of DNA to permit detection of very low amounts of cellular genes or genes of infectious agents.
Microarray technology, a recent discovery, enables rapid evaluation of the expression of many genes of a cell. This approach involves putting on a microscope slide extremely small amounts of cellular DNA or DNA copies of RNA that gives rise to the proteins of the cell. This technology helped identify the SARS agent by demonstrating its relationship to the genes of the coronavirus family placed on a microarray slide.
AIDS research, in which I have been involved for many years, has certainly benefited from biotechnology. Molecular techniques led to the full identification of the sequence of HIV. Other procedures in biotechnology permitted the establishment of methods for detection of HIV and immune responses to the virus.
Moreover, through biotechnology, highly purified proteins of HIV were obtained, permitting the discovery of drugs that specifically target these viral components. These medicines act against viral proteins with a specificity not possible without the knowledge gained from biotechnology research.
Essentially, biotech advances in this field have led to better diagnostic tests for defining HIV infection, for measuring the effect of the virus on the immune system and for the development of drugs that help control the virus.
From my own standpoint, biotechnology conducted in research institutions and industry promises to uncover novel approaches for improving immune function in HIV-infected individuals. For example, we have been working to identify an anti-HIV product of an immune cell called the CD8 lymphocyte that circulates in the blood and is present in lymphoid tissues of the body. This CD8+ cell antiviral factor (CAF) specifically inhibits HIV replication in infected cells but does not kill those cells. The CD8+ cell antiviral response is present in HIV-infected individuals who are healthy, particularly those who have lived more than 10 years (some for more than 25 years) without any signs of the infection. These long-term survivors control HIV through the activity of the CD8+ lymphocyte and CAF.
Obviously the identification of CAF would provide a major breakthrough for controlling HIV infection. But this novel protein is produced in such small amounts that standard procedures for identifying it have not been successful. CAF is most active when the CD8+ lymphocyte comes in contact with an infected cell; at this close interaction, the protein need not be there in high quantity. Biotechnology can help us to purify this potent anti-HIV factor by separating it from thousands of other products of the CD8+ cell.
The best promise comes from the recent technological advances in mass spectrometry, which can identify components of proteins at the atomic level. This approach has been greatly improved so that several proteins present in a semi-purified sample of CD8+ cell secretions can now be identified; previously, only one could be found. In preliminary studies, mass spectrometry of CAF- containing fluid has narrowed the anti-HIV activity to about 50 proteins. We trust that further purification steps will reduce this number to a reasonable amount for final analysis.
Additionally, through the novel approach of microarrays, the cellular gene expressing CAF is being sought. By taking RNA from cells producing CAF, and those that do not, we can compare the relative representation of many cellular genes and identify specific ones that are found in CAF-producing cells. One of them could be the CAF gene. This microarray approach has permitted us to narrow down the 37,000 human genes to a handful (about 25), one of which may indeed be responsible for producing this elusive CD8+ cell antiviral factor.
Essentially, through advancements in biotechnology, problems we now face can be better approached thanks to improvements in protein identification procedures and in gene detection methods. Ten years ago, none of these directions could have been undertaken with the same efficacy as is possible today. We look forward to the announcements of new technologies, new approaches and new discoveries in biotechnology that will continue to advance our ability to control HIV, as well as cancer and other human diseases.
Jay A. Levy, M.D., is a professor of medicine at UC San Francisco and director of the Laboratory for Tumor and AIDS Virus Research. He also serves on the executive committee of UCSF's AIDS Research Institute.
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