11/23/2004 R&D Directions Staff Pharmalive (www.pharmalive.com) A new term has entered the pharmaceutical developer’s glossary: theranostics. This word, created by the diagnostics company Pharma­Netics, defines the development of diagnostic tests that can identify which patients are most suited for a drug and provide feedback on how well the drug is working. The demand for theranostics is substantial, and the companies that produce these tests are reporting high-growth revenue rates. These companies tout the benefits of theranostic products: Patients get optimal treatment and excessive health-care expenditures can be reduced. These products will become more important in the coming years as health-care resources become even more limited, experts predict. Theranostics are a rapidly evolving group of specialized molecular diagnostic tests that are viewed as improving the real-time treatment of disease, making treatment more cost-effective, and adding value to the drug-development process. The concept of combining a drug with a diagnostic is also known as predictive medicine, personalized medicine, integrated medicine, pharmacodiagnostics, and Dx/Rx partnering. Theranostics go beyond traditional diagnostic products that only screen or confirm the presence of a disease. Theranostics can predict risks of disease, diagnose disease, stratify patients, and monitor therapeutic response. Theranostic products can provide physicians with information that enables them to individualize and optimize the therapeutic regimen of the patient. The physician may make better-informed decisions on timing, quantity, type of drugs, and choice of treatment procedure based on the relevant information provided by these tests. Recent advances in the understanding of the molecular pathways of disease have [...]

11/22/2004 Sapa www.iol.co.za Blood used in hospitals should be screened for the human herpes virus 8, a recently discovered virus which leads to Kaposi's sarcoma, particularly in HIV and Aids patients, the Medical Research Council has recommended. Kaposi's sarcoma was the leading cancer in many central, east and southern African countries, with rates "rapidly increasing" in South Africa, the MRC warned in its 2004 annual report. Other data from the MRC's cancer epidemiology research group showed that the percentage of lung cancer cases that could be ascribed to occupational environments (about 40 percent) was higher in a South African study than had been previously found in developed countries. About 3 500 patients were studied to measure the association of lung cancer and occupation, with increased risks found among miners and workers in chemical industries. In addition, 2 910 patients were examined to measure the association between HIV-infection and a number of socio-demographic characteristics. Alcohol consumption was found to be an important risk factor for HIV infection, probably due to its promotion of sexual risk-taking behaviour. "HIV-positive individuals were 3,5 times more likely to develop cancer of the vulva than HIV-negative individuals," read the report. Data from a case-control study were also analysed to determine the risk factors for cervical cancer among black women, with the results yet to be published. The association between hormonal contraceptive use and breast cancer was also investigated, with risks associated with the use of injectable progesterone contraceptives - widely used among black women since the [...]

11/22/2004 Chris Birk Scrantontimes.com "I didn't accept it as much as Mary (his wife) did," he said. "I had a tough time." "With me and our children, he managed to pull through," said Mrs. McHale. "Especially you, Mary," said her husband. Science says he may be right. Male cancer patients with wives or live-in partners have significantly higher survival rates than those who don't, according to a national study -- analyzing 1,822 people with head and neck cancer -- that included patients treated at Mercy Hospital in Scranton by local physician and cancer specialist Dr. Harmar D. Brereton. The intriguing, if intuitive, results were culled by a national team of physicians and coordinated through the Radiation Therapy Oncology Group, a cancer research base in Philadelphia. But the study, presented at a June conference, posits a rather one-sided worldview: Female patients with partners don't live any longer than those without. Explaining the absence of a supportive quid pro quo invites a host of social speculation. But Dr. Brereton is hopeful the new information will eventually help improve the lives of all cancer patients, regardless of gender. "The wonderful thing that came up, and it's something that all doctors know, is if you're married, you can't imagine how valuable that asset is in going through your treatment," said Dr. Brereton, of the Northeast Radiation Oncology Center in Dunmore. "Now that we're showing there's a real statistically significant survival advantage to that circumstance, how can we arrange for something that is a facsimile [...]

11/22/2004 Dale Chenoweth In recent years, knowledgeable biomedical researchers have sometimes wondered aloud whether the first approved gene therapy would come from a U.S. company, or instead from one in Europe or maybe even Britain. The answer, apparently, is none of the above. China Steps Out Ahead In March of this year the Chinese company Shenzhen SiBiono GeneTech Company, Ltd. began marketing in China a cancer gene therapy called Gendicine. The therapy was approved in October 2003 by China’s State Food and Drug Administration (SFDA) for use against squamous cell carcinoma of the head and neck (SCCHN), a category of solid tumors originating in such sites as the pharynx, larynx, oral cavity, and nose. In a self-interview published online last May, the company’s founder and chair, Zhouhui Peng, MD, said several Phase II and III trials among 135 patients with advanced SCCHN showed 64 percent had a complete response (CR) to the adenovirus-p53 drug used in combination with radiotherapy, and 29 percent had a partial response (PR). That’s significantly better than the response to chemotherapy and radiotherapy regimens that are now standard treatment in the U.S. and elsewhere. Additional trials involving another 240 patients also were positive, said SiBiono, but their data was not released. In all the trials, the drug was given by direct injection into accessible tumors. The easy accessibility of head and neck tumors for direct injection and their high incidence in China made SCCHN a good target disease, the company said. Over 1.6 million people worldwide [...]

11/21/2004 Andrew Schotz Herald-Mail Online A lower rate of smoking in Maryland has cut the amount of money available for health officials to curtail smoking. It's an interesting dilemma, but Earl Stoner, the director of health services for the Washington County Department of Health, isn't complaining. "If anything, you'd want to work yourself out of a job," he said. It's been six years since major tobacco manufacturers agreed to pay $206 billion to 46 states, Washington, D.C., and U.S. territories to settle a lawsuit. Four other states previously had negotiated their own $40 billion deal, according to a summary of the agreement posted at the National Conference of State Legislatures' Web site. Maryland's share is $4.4 billion, to be paid over 25 years, according to Carlessia Hussein, the director of the cigarette restitution fund program for the Maryland Department of Health & Mental Hygiene In the current fiscal year, Washington County is getting $277,122 for cancer prevention programs and $232,852 for tobacco-use prevention programs, Hussein said. The sum of the two amounts has dropped two straight years. The Washington County Health Department's funding was cut 13 percent from 2003 to 2004, then another 13 percent in 2005, said Kimberly Rasch, the program manager for the department's cancer surveillance and control program. The funding cuts forced the department to scale back its media campaign on colorectal cancer - a local focus - and left no money for prostate cancer ads, said William Christoffel, the county's health officer. Hussein said Maryland's overall [...]

11/19/2004 MC Haya-Fernandez et al. Oral Dis, November 1, 2004; 10(6): 346-8 Objectives: To determine the relationship between oral leukoplakia (OL) and oral squamous cell carcinoma (OSCC), and to evaluate possible differences between those carcinomas with and without associated leukoplakia. Material and methods: A total of 138 patients were studied at the Stomatology Service of the University General Hospital, Valencia, Spain. These patients were divided into two groups: group 1, patients with oral cancer and leukoplakia, and group 2, patients with OSCC but with no associated premalignant lesions. The relationship between this precancerous lesion and the OSCC was evaluated, as well as the possible clinical and histological differences between the tumours of the two groups. Results: Leukoplakia was detected in 27 (19.56%) patients with OSCC. No differences were found between the two groups regarding age and tumour location. However, statistically significant differences were observed with respect to the form, tumour stage and the presence of adenopathies in the cancers with and without leukoplakia; in that the tumours associated with leukoplakia were diagnosed as being at a more initial stage. Conclusions: Those patients with OL associated with oral cancer presented with tumours at a less advanced stage than those where no associated leukoplakia existed.

11/19/2004 Wang Hsiao-wen Tapei Times Every 8.5 minutes in Taiwan, one person is diagnosed with cancer, a report from the Department of Health unveiled yesterday. According to the Department's cancer registration report, some 61,000 people were found to have developed cancer in 2001 alone, a rise of 0.04 compared to 2000. For more than two decades, cancer has topped the list of causes of death in Taiwan. While liver and lung cancer are the most common cancers among men, cervical and breast cancer are the most common among women, the report said. An alarming trend is that oral and esophageal cancers have shot up among men. Compared to 2000, oral and esophageal cancer has leapt by 29.4 percent and 27.8 percent respectively. Most of these cases, health officials said, can be attributed to lifestyle factors. "It is impossible to fend off oral and esophageal cancers if people keep on smoking, drinking, and chewing betel nuts," said the bureau's deputy director-general, Chao Kun-yu. Chao said that oral cancer has spread from rural towns in central and southern Taiwan to the whole nation. Data on demographics also showed that 20-to-24-year-olds have seen biggest increase in oral cancer. "Most of the affected young people said they need to chew betel nut to keep them awake during work," Chao said, adding, "betel nut has become part of their life, and chewing it is ingrained in the culture here." The government has launched a publicity campaign to raise awareness of oral cancer, but addictive betel [...]

11/19/2004 Randall S. Johnson et al. Medical News Today The response of blood vessels to low oxygen levels may be the Achilles' heel of a developing tumor, according to a study led by University of California, San Diego biologists. The study, published in the November 15 issue of the journal Cancer Cell, is the first to examine how blood vessels respond to the low oxygen conditions that result from the presence of a growing tumor. Previous work by the UCSD group and others has shown that tumors, which need a blood supply to provide oxygen and nutrients, release chemical signals that summon the blood vessels to grow toward them. However, these latest findings show that the blood vessels themselves are actively responding to oxygen levels, not just to the signals sent by the tumor. According to the researchers, developing drugs that interfere with the blood vessels' response to low oxygen may be a potent anti-tumor strategy. “We show that the blood vessels' response to lack of oxygen is just as important as the response of cancer cells to lack of oxygen,” said Randall Johnson, a professor of biology at UCSD who headed the research team. “We identified a gene that turns on in the cells lining blood vessels when they are not getting enough oxygen and showed that without this gene the blood vessels cannot grow to nourish the developing tumor. Drugs that interfere with this gene, or another gene involved in the blood vessels' response, should block tumor growth.” [...]

11/19/2004 Harari PM, Giralt JL, Chinnaiyan P, et al. Annals of Oncology. 2004;15, supplement 3:iii13, abstract 46IN An international multi-center study has concluded that the addition of Erbitux™ (cetuximab) to radiation therapy reduces locoregional recurrences and improves survival in patients with advanced head and neck cancer. This study, carried out between 1999 and 2002, was reported at the 2004 meeting of the European Society of Medical Oncology (ESMO). This study randomly allocated 424 patients with stage III/IV head and neck cancer to receive radiation therapy with curative intent alone or in conjunction with Erbitux™. The researchers reported that the addition of Erbitux™ decreased locoregional disease recurrences by 8% at 2 years and improved survival by 13% at 3 years. Erbitux™ was well tolerated and did not interfere with wound healing in patients undergoing post-radiation neck dissections. Comments: This study appears to be “proof of principle” that an EGFR inhibitor can improve outcomes of patients with head and neck cancer receiving radiation therapy. Whether this is better than adjuvant chemotherapy remains to be determined. A major advantage of this approach is lack of toxicity and the main disadvantage will be cost. It will probably be necessary to compare outcomes with chemotherapy before widely adopted. Reference: Harari PM, Giralt JL, Chinnaiyan P, et al. Results of an international phase III trial or radiation +/- cetuximab (Erbitux™) in patients with locoregionally advanced head and neck (H&H) cancer. Proceedings of the 2004 meeting of the European Society of Medical Oncology. Annals of Oncology. 2004;15, [...]

11/19/2004 Clara Pirani The Weekend Australian Researchers have discovered a way to accurately predict which tumours will recur in some cancer patients. Surgeons and researchers at the Princess Alexandra Hospital in Brisbane and the Queensland Institute of Medical Research have identified genetic markers within human tissue that can be analysed to predict which cancers will recur after surgery or chemotherapy. Between 1997 and 2001, the researchers removed and stored tumours from 100 people suffering head and neck cancer. They examined the tumours to predict what would be the outcome, and then went back to confirm what had actually happened to the patients. "It was amazing," said Dr David Chin, a senior lecturer in head and neck disease in Princess Alexandra Hospital and the University of Queensland. "We were able to predict very accurately which cancer tumours would reoccur and which ones wouldn't." He said doctors will now be able to perform a biopsy, by removing tissue from inside the mouth, and then identify the genetic makeup by applying a stain to the tissue. "The markers identified have never been previously described in any human cancer before and are extremely accurate in identifying patients at risk of recurrence. "So now, by doing a routine biopsy before surgery, we'll be able to tell whether the tumour will be very aggressive or whether the patient needs surgery or radiation or chemotherapy." Dr Chin believes the method can be used to develop individual treatments for patients and avoid unnecessary surgery. "Patients suffer when they [...]