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To: bob zagorin who wrote (1402)	5/9/2001 12:36:55 PM
From: bob zagorin	of 1971

here's another VEGF story. although VICL's patent would deliver it, i still think it's interesting to keep track of the connections. Tuesday May 8 5:52 PM ET Hormone May Spur Tumor Blood Vessel Growth By Merritt McKinney NEW YORK (Reuters Health) - The hormone progesterone may contribute to breast cancer by boosting a blood vessel growth factor that helps tumors to grow, according to results of a preliminary study conducted on laboratory-grown cancer cells. The hormone appears to stimulate production of VEGF, which is involved in the creation of blood vessels for normal cells and tumors--a process called angiogenesis. The findings suggest one reason why medications that block progesterone may be useful for treating breast cancer. In the study, the researchers used the abortion drug RU-486--which is a progesterone-blocking agent--to halt the process in the laboratory. Progesterone is the hormone that prepares the uterus for egg implantation and pregnancy. Estrogen has been shown to help regulate the expression of VEGF (or vascular endothelial growth factor) in breast cancer cells, but less is known about the effects of progesterone. The results of the research are not surprising, according to Dr. Fairooz Kabbinavar, of the Jonsson Comprehensive Cancer Center at the University of California, Los Angeles. The study is ``a small piece of the puzzle that tells you that cancer and malignant angiogenesis go hand-in-hand,'' he told Reuters Health in an interview. It helps ``unlock the mechanism'' of the creation of blood vessels to supply tumors, according to Kabbinavar, who was not involved in the study. Although RU-486 has not been used to treat breast cancer, Kabbinavar said that other drugs that block progesterone are used to treat the disease. Even though the study found a link between progesterone and the secretion of VEGF, Kabbinavar said the study ``should not increase the level of concern'' for women taking hormone replacement therapy that contains a progestin, a synthetic version of progesterone. He pointed out that the findings are based on laboratory experiments in a single type of breast cancer cell. In the study, Dr. Salman M. Hyder and colleagues at the University of Texas Health Science Center-Houston exposed human breast cancer cells to progestins. Within a few hours of exposing the cells to progestins, the expression of VEGF increased two to five times, according to the report in the International Journal of Cancer. The investigators achieved similar results when they tested a variety of naturally occurring and man-made progestins that are used in hormone replacement therapy and birth control pills. But when the researchers added RU-486, which blocks the activity of progestins, the increased expression of VEGF stopped. Since VEGF can increase the size of normal and cancerous tissues, progestin may accelerate the growth of some types of breast tumors, Hyder and colleagues report. This activity of progestins, the team points out, could be ``particularly insidious'' in women with undiagnosed tumors that were triggered by estrogen and then encouraged by progestins--either natural or pharmaceutical versions. There is some concern that progestins may encourage the progression of some types of breast cancer, Hyder told Reuters Health in an interview. This study ``suggests that this may be the case,'' he said. He noted that some research has indicated that the risk of breast cancer may be elevated in women taking estrogen in combination with a progestin but not in women taking estrogen alone. The current research may help explain the increased risk for women taking a progestin, according to Hyder. But the Texas researcher cautioned that the apparent effects of progestins on VEGF need to be confirmed. ``It's too soon to conclude anything,'' he stated. Hyder also noted that for women who still have an intact uterus, progestins are necessary to prevent uterine cancer in women taking estrogen replacement. And some studies have found that high doses of progestins can actually be beneficial for some breast cancer patients. Much more study is needed to determine if the laboratory results actually translate into risks for healthy women, or those with breast cancer. SOURCE: International Journal of Cancer 2001;92:469-473.

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To: William Strop who wrote (1400)	5/13/2001 12:36:24 AM
From: Scott H. Davis	of 1971

Catching up after being out all week. The impression I'm getting (releases, listening to the CCall) is that they have been super careful with this trial, and that they have placed more weight on this once, vs Luv. due to the better data. This is the 1st potential gene therapy to be approved. We saw how when the PII for Luv did not look good, they pulled back, rather than spin doctoring, trying to salvage by looking at a sub group.... This is a careful company. They have earned my confidence, IMHO. It's my largest holding. We're single income, and investing significantly generationally - home-schooling and doing major therapeutic interventions for a child with multiple disabilities. I can't afford to be way off with this large a stake, when I may need the cash a year from now for my son. IMSCO Scott

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To: bob zagorin who wrote (1404)	5/13/2001 1:05:40 AM
From: Scott H. Davis	of 1971

All: Some vaccine observations from a father who's son's life was profoundly altered by clueless vaccine administration. I've just spent two days at the Defeat Autism Now Conference. There is a quickly growing body of evidence showing the huge harm that has been delivered by old technology vaccines administered in concordance with a public health mindset, augmented by hure dogma & fear of reprisal. You've seen how cautious VICL jhas been with their trials. You've seen their great side effect profile in trials. In contract. There was NO safty trrial for Rubella. The MMR trial had patients followed for 28 days, in the face of a 3x increase in GI tract problems in the US based group were the incidence of GI tract problems 22+% post-vaccine vs 5.6% pre-vaccination. The HEP B vaccine trial had patients followed for 5 days, and the symptoms monitored for included in the trial were very limited. A man-made health epidemic. Autism has increased 1,000% in the last 20 years. VICAL does not introduce live virus. Merek was one of the 1st to abandon mercury bearing vaccine formulations (hint, autism & Hg poising have INCREDIBLY similar effects) VICL is partnered with MRK. VICL sweats the data & does the right thing. The other vaccine companies are facing a liability exposure that will dwarf the tobbaco companies. Could type for an hour, but need to shut down. Scott

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To: bob zagorin who wrote (1404)	5/14/2001 10:20:28 AM
From: Scott H. Davis	of 1971

Vical Presents Promising Interim Data From Phase II Allovectin-7(R) Melanoma Registration Trial at ASCO SAN FRANCISCO, May 14 /PRNewswire/ -- Dr. Rene Gonzalez (University of Colorado Medical Center), on behalf of the clinical centers working with Vical Incorporated (Nasdaq: VICL - news), presented promising interim safety and efficacy data from the company's Phase II Allovectin-7® registration trial for patients with late-stage metastatic melanoma at the annual meeting of the American Society of Clinical Oncology (ASCO). Vijay B. Samant, Vical's President and Chief Executive Officer, said, ``These interim data are consistent with previously reported data, and may support a filing for marketing approval. We are excited by the durable nature of the systemic responses, which can provide a meaningful benefit to patients. The exceptional safety and tolerability of Allovectin-7®, both during the treatment cycle and throughout the response period, are particularly important in maintaining a good quality of life for patients.'' The company reported interim data for 73 patients who received at least one injection of Allovectin-7® (intent-to-treat patient population), including 54 patients who received at least one full treatment cycle (evaluable patient population). The conclusions based on these data were that the median duration of response and response rate to date confirm the activity of Allovectin-7®, and that the safety profile of Allovectin-7® remains excellent in comparison to approved treatments for metastatic melanoma. Several patients are still in treatment or followup under the Phase II trial, and final results are expected by year-end 2001. In addition, a concurrent Phase III Allovectin-7® registration trial is expected to complete enrollment of patients with newly diagnosed metastatic melanoma in the third quarter of 2001. Positive data from either trial could lead to marketing approval. In the Phase II registration trial, treatment with Allovectin-7® resulted in a reduction in total tumor burden of 50 percent or more (systemic clinical responses) in 14.8 percent of the evaluable patients with a current median duration of response of approximately 5 months. Two of the patients, or 4 percent of the evaluable group, experienced complete responses in which all detectable tumors were eliminated. An additional 26 percent of the evaluable patients achieved stable disease, some with reductions in total tumor burden that are significant but did not reach 50 percent. On an intent-to-treat basis, 11 percent of the patients experienced systemic clinical responses, and an additional 19 percent achieved stable disease. The trial enrolled patients who have failed other treatments. All but 1 percent of the drug-related side effects were mild or moderate. Melanoma is currently treated with chemotherapy, biotherapy, or combinations of chemotherapy and biotherapy. Toxicity with such treatments is often significant, resulting in serious or life-threatening side effects in 50 percent or more of the patients treated. ``The continued excellent safety record of Allovectin-7® and the growing body of efficacy data support its potential to be the first gene-based product to gain marketing approval,'' added Mr. Samant. ``We will monitor the progress of patients remaining on study, and look forward to providing a complete report and guidance on the direction of our registration program by year-end.'' Allovectin-7® Allovectin-7® is a DNA/lipid complex containing the human gene encoding the HLA-B7 antigen. Allovectin-7® is designed to be injected directly into a tumor, where malignant cells may absorb it and express the HLA-B7 antigen. This antigen may alert the immune system to the presence of foreign tissue, inducing the type of powerful immune response seen in organ transplant rejection. In addition, the treatment may trigger an immune response against additional tumor cells, both locally and systemically, by enabling the immune system to recognize other features of the tumor cells. Registration Program Vical's Allovectin-7® registration program consists of two separate trials in patients with metastatic melanoma, either or both of which could lead to registration for their respective patient populations if endpoints are achieved. The Phase II trial is designed to confirm the efficacy of Allovectin-7® in patients with refractory (unresponsive to standard therapy) melanoma that has not yet spread to multiple internal organs. The Phase III trial is designed to demonstrate the efficacy of Allovectin-7® when used with standard chemotherapy in patients with metastatic melanoma not previously treated with chemotherapy. Vical Incorporated, The Naked DNA Company(TM), is focused on the development of pharmaceutical product candidates based on its patented gene delivery technology. A number of therapeutic and vaccine product candidates are currently under development for the prevention or treatment of cancer, infectious diseases and metabolic disorders by Vical and its collaborative partners, including Merck & Co., Pfizer Inc., Aventis Pasteur, Aventis Pharma, Human Genome Sciences, Centocor Inc., Merial and Boston Scientific Corporation. Allovectin-7®, which uses a lipid-DNA complex to help the immune system recognize and attack cancer cells, is in Phase II and Phase III testing in certain patients with metastatic melanoma and in Phase II testing in patients with head and neck cancer. Leuvectin(TM), which uses a lipid-DNA complex to stimulate an immune response against cancer cells, is in Phase II testing in patients with prostate cancer. Vaxid, a naked DNA vaccine to prevent relapse of B-cell lymphoma, is in Phase I/II testing. In collaboration with the National Cancer Institute, a naked DNA vaccine to treat metastatic melanoma is in Phase I/II testing. If you are interested in any of Vical's clinical trials, please see our website at www.vical.com, or contact Tammy Boyce by phone at 858/646-1120 or by e-mail at tboyce@vical.com.

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To: bob clark who started this subject	5/14/2001 1:44:23 PM
From: bob zagorin	of 1971

Preliminary Research Displays Progress for Cancer Vaccines By DAVID P. HAMILTON Staff Reporter of THE WALL STREET JOURNAL SAN FRANCISCO -- Scientists reported early progress in new cancer-vaccine treatments, in which the body's own immune system is prompted to target and eliminate the genetically damaged cells responsible for cancer. In two studies reported Sunday at the annual meeting of the American Society of Clinical Oncology here, researchers presented preliminary data showing that treating late-stage cancer patients with vaccines made from their own cells can stabilize or shrink tumors, sometimes completely eliminating them. Vaccines are part of a broader focus on therapies targeted at the molecular basis of cancer. While other promising efforts are focused on blocking cellular signals that can cause cells to grow uncontrollably, the developers of cancer vaccines hope to trick the body's defenses, which normally ignore cancer, to seek out and destroy cancer cells directly. The new studies involve relatively small numbers of patients and lack the rigorous control measures used to verify the effectiveness of most medical treatments. Furthermore, these researchers have only tracked the progress of patients for several months to a year, leaving it unclear how these treatments will affect long-term survival. Still, these response rates are far higher than those seen on average in such preliminary studies over the last 20 years, said Michael Gordon, a cancer specialist at the University of Arizona. In addition, even this early research has helped some patients who had exhausted traditional radiation or chemotherapy treatments, raising hopes that vaccines might be far more effective in early cancers or when combined with other treatments. In a Stanford University study, a team led by researcher Lawrence Fong treated patients with advanced lung or colorectal cancer with altered versions of their own dendritic cells, which help other immune cells identify threats to the body. When exposed to a slightly altered version of a protein common to gastrointestinal cancers and reinjected into the body, these dendritic cells apparently helped disease-fighting T cells target tumor cells. Of the 12 patients treated, two saw their tumors vanish, although they recurred in one patient after eight months. Tumors stabilized in two other patients, but began growing again after six months. Meanwhile, preliminary data from a larger test showed that eight of 22 late-stage lung-cancer patients saw their tumors stabilize or shrink after treatment with a vaccine developed by Cell Genesys Inc., of Foster City, Calif. The Cell Genesys vaccine is derived from whole cells extracted from a patient's tumor, which are then genetically modified to express a protein designed to trigger an immune response. Cell Genesys is the test sponsor. Separately, European scientists reported at the meeting here that Aranesp, a not-yet-approved anemia treatment from Amgen Inc., of Thousand Oaks, Calif., can help slow the progression of certain lung cancers. A large controlled study showed that half of small-cell lung-cancer patients who received Aranesp with chemotherapy went at least 34 weeks without experiencing renewed progression of the disease, compared with 23 weeks for those who received the placebo. It isn't entirely clear why Aranesp, which stimulates the production of red blood cells, would affect the progression of cancer, said Robert Pirker, a University of Vienna researcher who oversaw the trial. Other studies, however, have linked the level of hemoglobin, an oxygen-carrying molecule in red blood cells, to patients' responsiveness to radiation therapy.

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To: bob clark who started this subject	5/15/2001 1:02:45 PM
From: bob zagorin	of 1971

Source: Thomas Jefferson University Hospital Date Posted: Tuesday, May 15, 2001 Web Address: sciencedaily.com Cancer Vaccine May Help Patients With Melanoma Spread To The Lungs A custom-made vaccine created from a patient’s own cancer tumor cells appears effective in prolonging the survival of patients with malignant melanoma, the deadliest form of the skin cancer, that is removed after having spread to the lung. David Berd, M.D., professor of medicine at Jefferson Medical College of Thomas Jefferson University in Philadelphia and a member of Jefferson’s Kimmel Cancer Center, and his colleagues had previously shown the vaccine was effective in treating patients with malignant melanoma, the fastest growing cancer in the United States. The vaccine is termed autologous, meaning that it’s prepared from a patient’s own cancer cells. Before injecting the cells into patients, the cells are inactivated and then treated with dinitrophenyl (DNP), which is a chemical known as a hapten and which modifies them. The altered cells appear foreign enough to the immune system for it to react against them. In the current study, Dr. Berd and his co-workers gave the vaccine to 37 patients with advanced (stage IV) melanoma that has spread beyond the lymph nodes. Twenty patients had cancer that had spread to the lung. The others had disease spread to other areas. Each had surgery to completely remove the cancer. Dr. Berd found that giving the DNP vaccine to those patients following their surgery resulted in an estimated 59 percent of patients living three years, which he terms a “good response for these patients.” Only 10 to 20 percent of such patients typically live five years or more with surgery alone. He reports his team’s results May 14 at the annual meeting of the American Society of Clinical Oncology in San Francisco. “The unexpected finding is that those with lung metastasis so far are doing better than those with soft tissue metastasis,” says Dr. Berd. “The opposite should be true according to what is published in the medical literature. This goes along with our previous observation that the vaccine is more likely to cause shrinkage of inoperable lung metastases than of skin metastases.” The researchers also found that nearly all of the patients had a positive immunological skin test called the delayed-type hypersensitivity (DTH) test, indicating an aroused immune system to their own tumor cells following vaccine. Dr. Berd has shown in the past that the patients who had a better DTH response to the modified cancer cells lived longer than those who did not. Dr. Berd has shown the vaccine to be effective in other trials. In an expanded Phase II trial of 214 melanoma patients with disease spread to either one or two lymph node areas, he reported last year that 47 percent lived for five years. Those with cancer spread to only one lymph node area did even better (50 percent five-year survival). The surgical cure rate is about 20 percent for these patients. Dr. Berd and his colleagues participate in a Phase III trial to test the effectiveness of the vaccine on patients with disease that has spread to the lymph nodes. AVAX Technologies, Inc., of Kansas City, MO, which has exclusive rights to the Jefferson-based vaccine against malignant melanoma, sponsors the trial. The five-year randomized trial compares the effectiveness of the melanoma vaccine to the standard treatment, which is alpha interferon. The trial will involve approximately 400 patients seen at institutions in several major cities. More than 40,000 new cases and 7,000 deaths will occur this year from the disease, the fifth most common cancer in the nation.

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To: bob clark who started this subject	5/16/2001 8:07:22 PM
From: bob zagorin	of 1971

Doctors report nerve repair in gene therapy By Globe Staff, 5/15/2001 octors trying to grow new blood vessels in the legs of patients with poor circulation yesterday reported an unexpected result: In 10 of 19 patients, the gene therapy treatment appeared to repair nerve damage that is usually considered irreversible. Researchers at St. Elizabeth's Medical Center in Brighton, led by Dr. Drasko Simovic, assistant professor of neurology at Tufts University School of Medicine, cautioned that the results are preliminary, since the study had no control group and some results could be attributable to a placebo effect. They now want a controlled trial to explore whether a growth factor that stimulates blood vessel growth also repairs nerves, either by boosting growth of microscopic blood vessels in nerve walls, or by causing growth of nerves themselves. The findings, reported in this month's Archives of Neurology, were derived from Dr. Jeffrey Isner's study of patients with arterial disease severe enough to possibly require amputation. Funded by Genzyme, the study's aim was to improve circulation by injecting vascular endothelial growth factor to grow blood vessels. One patient, whom Simovic called ''very observant,'' noticed that the numbness that used to spread across much of his leg had shrunk to a small patch. The researchers then began testing nerve response as well as blood vessel growth. They started with 29 patients; after six months, 17 had not dropped out or suffered amputations. Electrical tests showed that nerve function improved in 10 of the 19 limbs being treated. Twelve patients reported decreased symptoms. Four of six diabetic patients showed improvement. By contrast, there was no neurological improvement in any of the patients who didn't receive the injections, Draskovic said. ANNE BARNARD This story ran on page 2 of the Boston Globe on 5/15/2001.

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