50),
d) no.

Eight centres recommend colectomy with IRA and two recommend restorative proctocolectomy with ileo-anal pouch anastomosis (universally in one centre and if rectal cancer present in another). One British centre recommended extended hemicolectomy, and one European centre a hemicolectomy. Three centres did not use this information to influence surgical planning, although one would consult surgeons informed with this data. None of the centres recommended conventional oncological surgery, but six centres left the decision to surgical colleagues as evidence is inadequate. MSI or IHC testing was influential in surgical planning recommendations where in the context of an HNPCC pedigree (10 centres), or in patients under 50 years of age (5 centres) or in any case (3 centres). In one of the latter, the respondent commented that the finding of loss of MLH1 or low level microsatellite instability might influence the surgical approach, except where the promoter region has not been analysed for its methylation status.

Discussion

This survey conducted from September 2003 to January 2004 was designed to highlight common counselling and management questions relating to HNPCC, especially where the evidence base for decision making is poor or non-existent. Limitations to the survey are recognised: continental Europe, especially outside Denmark, and the USA are not well represented. There were also no responses from Africa, Asia, Japan or South America. Nevertheless, the responding centres do represent clinics whose opinions are influential in InSiGHT and the HNPCC community.

Of interest was the wide variety of cancers potentially included in the definition of HNPCC which would inform a decision to proceed directly to mutational analysis. Direct testing without IHC or MSI for families where Amsterdam I or II criteria have been met was common. Most centres also accept other cancers for which there have been statistical associations made of increased prevalence in HNPCC [2, 4-10]. Five centres even accepted breast cancer in hMLH families as relevant in this context [1].
Clinic intake threshold criteria probably relate more to the provision of adequate funding and other (human) resources than scientific scrutiny. In general, thresholds were lower in user pay medical models, and more restricted in other settings.

Strategies of use of IHC and MSI were generally to offer both. As more recent data are emerging, this practice is probably changing due to the high concordance between the two tests and the added value of specific gene identification provided by IHC. We suspect that clinics currently are moving to using IHC as their main form of testing, with MSI reserved for special circumstances.

Consent for pre-genetic testing is a controversial area of counselling practice. Some would say that the finding of loss of expression of a mismatch repair gene (especially MSH2) is tantamount to a germline diagnosis, and so all the elements of counselling that go into consent for germline testing should precede a request for IHC. Others would propose that IHC and MSI are somatic phenomena and conceptually little different to any other phenotypic marker available for histopathological characterisation; indeed they would argue that the pathologist is duty bound to provide such information to inform clinical practice for that patient. This argument is increasingly supported by data that differentiate responses to chemotherapy based on MSI status [11, 12], and similarly the risk of metachronous cancer. Finally, advocates of routine IHC testing, perhaps age restricted, point out that this will be the best strategy to identify all HNPCC families in the community for appropriate counselling and surveillance. We suspect that standards of consent for IHC and MSI testing are also changing in different locations, pressured by forces protecting privacy versus public good to differing degrees, depending on local sociological and legal influences.

The place of the Bethesda criteria in deciding on pre-genetic testing has been the subject of two consensus round table meetings [13, 14]. Our questionnaire was completed before the most recent revisions were published in Febuary 2004 [14]. This consensus has rendered the criteria less specific. Nevertheless, it was interesting to see the distribution of approach to these criteria: nine restricted testing to Bethesda indications, three were less restrictive but two were more restrictive. It will be interesting to see how the 2004 conference criteria play out in current clinical practice. We suspect that their lack of specificity will make them unworkable.

Most centres in this survey reported that their pre-genetic, mutational analyses and predictive testing laboratory services were publicly funded. Notable exceptions to this observation are centres from the USA. Although comment on this is beyond the scope of this article, lack of public funding must influence the impact that familial counselling can have across families in the community who have variable socio-economic status and capacity to pay.

The DNA mutational analysis strategies were quite variable across centres. The variability partly reflects the (rapid) developmental state of technology in this discipline. It also offers opportunity for systematic comparison of the efficiency of different strategies, stratified on clinical (e.g. Bethesda) entry criteria, to be evaluated. Cost effectiveness studies could follow.

Disclosure of information about family specific mutations in hereditary bowel cancer generally follows the conventional clinical genetics model, leaving the responsibility to probands with mutations identified. Variations on this theme include providing letters to the probands to facilitate accurate information transfer. The success of this policy is under scrutiny in several centres, with some clinics moving to directly inform at-risk individuals known by the clinic to be at genetic risk. One study shows a high level of communication failure to all at-risk family members, despite genetic counselling (11 of 12 patients) [15]. Our own experience has been of young family members developing advanced bowel cancer after distant family counselling which has included the need to inform other family members. Genetic counselling and modes of disclosure have been bound down in many countries by privacy considerations, often enshrined in law. We consider that in the case of FAP at least with its 100% penetrance for polyposis and cancer and a clearly remedial strategy available to intercept the cancer risk, privacy considerations have transgressed common sense at the expense of the public good.

Surveillance recommendations were more consistent across the centres worldwide. There was some variation related to intrinsic differences in the definition of HNPCC (see above). Most centres will advise screening based on family history regardless of genetic information (except in individuals testing negative in families with a known mutation). Non-informative mutational analysis or positive results of pre-genetic testing were in general not determinants of surveillance planning in themselves. On the other hand, if a germline mutation is found, HNPCC surveillance is recommended for carriers regardless of family history. Frequency of screening is generally consistent at one to two yearly. Gynaecological surveillance advice was highly variable, probably reflecting the lack of evidence for benefit and the lower incidence of gynaecological cancers compared with colorectal cancers. Starting ages of surveillance also varied. The categories of people offered surveillance also varied considerably across the centres. There is room for a randomised controlled trial of gynaecological surveillance in HNPCC registries to help address these uncertainties.

Of considerable topical interest were surveillance recommendations for non-colorectal, non-gynaecological sites. The issue often arises in clinical practice. There is no evidence base for these recommendations as the frequency is too low to allow clinical studies. An audit of outcomes from use of a standard protocol could be considered through international cooperation.

Surgical prophylaxis for gynaecological sites was discussed in most centres, reflecting likely uncertainty about the benefits of gynaecological surveillance and the relative lack of function of the endometrium and, to a lesser extent, ovaries after child bearing is complete.

Almost all centres recommended extended colonic surgery as the primary surgical approach in HNPCC. This survey did not have responses from French centres where such advice is less favoured [16]. Indeed, in the absence of evidence, there is currently a German-initiated randomised controlled trial of extended versus oncological resection recruiting in Europe. The success of surveillance by colonoscopy after a more limited (oncological) resection will blunt the benefit (of preventing metachronous tumours) afforded by extended surgery.


Conclusion

The survey conducted in the last three months of 2003 has provided unique information about the clinical practices and recommendations of eighteen familial cancer clinics around the world. The questionnaire covered clinical definition of HNPCC, clinical intakes, indications and funding for pre-genetic testing and mutational analysis, counselling, surveillance planning, and surgical decision making. Newer information, which may have influenced contemporary practice, has also been discussed. The field of cancer genetics is advancing quickly; therefore readers should be cognisant of the time window of these responses. We consider this paper to be a valuable and systematic catalogue of difficult but common issues in familial cancer clinics, which can act as a sounding board for practitioners in HNPCC.


Acknowledgements
Dr Elizabeth Chow is supported by the Edith Viola Reed Scholarship, Faculty of Medicine, University of Melbourne, and Hicks Foundation Scholarship.
References
1. Scott RJ, McPhillips M, Meldrum CJ, Fitzgerald PE, Adams K, Spigelman AD, du Sart D, Tucker K, Kirk J and Hunter Family Cancer Service. Hereditary nonpolyposis colorectal cancer in 95 families: differences and similarities between mutation-positive and mutation-negative kindreds. Am J Hum Genet 2001; 68: 118-127.
2. Aarnio M, Sankila R, Pukkala E, Salovaara R, Aaltonen LA, de la Chapelle A, Peltomaki P, Mecklin JP and Jarvinen HJ. Cancer risk in mutation carriers of DNA-mismatch-repair genes. Int J Cancer 1999; 81: 214-218.
3. Wijnen JT, Vasen HF, Khan PM, Zwinderman AH, van der Klift H, Mulder A, Tops C, Moller P and Fodde R. Clinical findings with implications for genetic testing in families with clustering of colorectal cancer. N Eng J Med 1998; 339: 511-518.
4. Aarnio M, Mecklin JP, Aaltonen LA, Nystrom-Lahti M and Jarvinen HJ. Life-time risk of different cancers in hereditary non-polyposis colorectal cancer (HNPCC) syndrome. Int J Cancer 1995; 64: 430-433.
5. Dunlop MG, Farrington SM, Carothers AD, Wyllie AH, Sharp L, Burn J, Liu B, Kinzler KW and Vogelstein B. Cancer risk associated with germline DNA mismatch repair gene mutations. Hum Mol Genet 1997; 6: 105-110.
6. Sijmons RH, Kiemeney LA, Witjes JA and Vasen HF. Urinary tract cancer and hereditary nonpolyposis colorectal cancer: risks and screening options. J Urol 1998; 160: 466-470.
7. Vasen HF, Stormorken A, Menko FH, Nagengast FM, Kleibeuker JH, Griffioen G, Taal BG, Moller P and Wijnen JT. MSH2 mutation carriers are at higher risk of cancer than MLH1 mutation carriers: a study of hereditary nonpolyposis colorectal cancer families. J Clin Oncol 2001; 19: 4074-4080.
8. Watson P and Lynch HT. Cancer risk in mismatch repair gene mutation carriers. Fam Cancer 2001; 1: 57-60.
9. Vasen HF, Wijnen JT, Menko FH, Kleibeuker JH, Taal BG, Griffioen G, Nagengast FM, Meijers-Heijboer EH, Bertario L, Varesco L, Bisgaard ML, Mohr J, Fodde R and Khan PM. Cancer risk in families with hereditary nonpolyposis colorectal cancer diagnosed by mutation analysis. [erratum appears in Gastroenterology 1996; 111: 1402]. Gastroenterology 1996; 110: 1020-1027.
10. Watson P and Lynch HT. Extracolonic cancer in hereditary nonpolyposis colorectal cancer. Cancer 1993; 71: 677-685.
11. Gryfe R, Kim H, Hsieh ET, Aronson MD, Holowaty EJ, Bull SB, Redston M and Gallinger S. Tumor microsatellite instability and clinical outcome in young patients with colorectal cancer. N Eng J Med 2000; 342: 69-77.
12. Elsaleh H and Iacopetta B. Microsatellite instability is a predictive marker for survival benefit from adjuvant chemotherapy in a population-based series of stage III colorectal carcinoma. Clin Colorectal Cancer 2001; 1: 104-109.
13. Rodriguez-Bigas MA, Boland CR, Hamilton SR, Henson DE, Jass JR, Khan PM, Lynch H, Perucho M, Smyrk T, Sobin L and Srivastava S. A National Cancer Institute Workshop on Hereditary Nonpolyposis Colorectal Cancer Syndrome: meeting highlights and Bethesda guidelines. J Natl Cancer Inst 1997; 89: 1758-1762.
14. Umar A, Boland CR, Terdiman JP, Syngal S, de la Chapelle A, Ruschoff J, Fishel R, Lindor NM, Burgart LJ, Hamelin R, Hamilton SR, Hiatt RA, Jass J, Lindblom A, Lynch HT, Peltomaki P, Ramsey SD, Rodriguez-Bigas MA, Vasen HF, Hawk ET, Barrett JC, Freedman AN and Srivastava S. Revised Bethesda Guidelines for hereditary nonpolyposis colorectal cancer (Lynch syndrome) and microsatellite instability. J Natl Cancer Inst 2004; 96: 261-268.
15. Gaff CL, Collins V, Symes T and Halliday J. Facilitating family communication about predictive genetic testing: probands' perceptions. J Genet Couns 2005; 14: 133-140.
16. Olschwang S, Laurent-Puig P, Eisinger F and Millat B. An alternative to prophylactic colectomy for colon cancer prevention in HNPCC syndrome. Gut 2005; 54: 169-173.

Similar posts: clinical oncology

The Florida Hospital Neuro Division provides the opportunity to excel with one of the largest medical centers in the nation, and one of the most comprehensive institutes of its kind in the Southeast. Our highly skilled Neuro team treats more stroke patients and performs more neurosurgeries than any other hospital system in the state of FL. Supported by recognized physicians, highly trained health care professionals, technologically advanced diagnostic equipment and treatment facilities, comprehensive rehabilitation programs and clinical research, Florida Hospital has been recognized by US News World Report as one of s Best Hospitals for Neurology and Neurosurgery Services. So, its probably no surprise that our Neuro and Neuro Critical Care nurses are some of the most impressive in the field.

Job Description:

The RN is a registered professional nurse who is responsible for providing and supervising direct and indirect total nursing care responsibilities to identified age specific groups. Utilizing the nursing process (assessing, planning, implementing and evaluating) in achieving the goals of the nursing department. Adheres to the Florida Hospital Corporate Compliance Plan and to all rules and regulations of all applicable local, state and federal agencies and accrediting bodies. Actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all.

Position: Registered Nurse
Unit: Neuro ICU
Hours: Full-Time, 72 hours per pay period.
Knowledge Skill Required: 1-3 years of recent acute-care hospital experience as a Registered Nurse required; Neuro, ICU and telemetry experience preferred. We will train for telemetry if needed.
Education, Licensure Certifications: Must be a graduate of an accredited school of nursing. Must hold a Registered Nurse license in the state of Florida, or actively be pursuing reciprocity from another state. Basic Life Support certification required; CNRN and ACLS a plus!

The Neuro Critical Care Unit is a 16 bed acute care unit. The nurse to patient ratio is 1:2. The patient population consists primarily of surgical patients, including spinal and brain surgeries, hemorrhagic pathologies, brain attack patients, medical neurological pathologies and seizures.

Additional features of the unit include:
Neuro specific education and training programs; professional certification reimbursement program
Specialized education for unit resource nurses to assist in complex management of pain, diabetes, geriatric care, spiritual needs and advance directive issues
Burst suppression monitoring
Active Neuro collaborative practice team
Evidence Based Practice Protocols improving patient outcomes
Participation in Neuro Research Protocols
Dedicated Clinical Nurse Specialist and Education Specialist
On unit Assistant Nurse Manager without patient assignment
Unit Mentors
Dedicated Neuro case managers
Unit Practice Council providing grass roots leadership
Team scheduling
Computerized documentation
Pet Therapy
Clinical Ladder
Patient and Family Support Groups

Experienced? We welcome experienced Neuroscience and Neuro Critical Care Nurses to our family. We also embrace experienced Progressive Care, Intensive Care and Medical Surgical Nurses with an interest in Neuroscience or Neuro Critical Care into our comprehensive training programs.

Is Professional Recognition Important To You? Involvement in our clinical ladder model, the Professional Practice Program, provides you with professional and financial recognition for excellence at the bedside.

Join Our Team! Join us in our passion for Neuro Nursing in an environment where you have the opportunity to learn and grow, share your expertise, and become one of the best resources Florida Hospital has to offer. Our program is truly N E U R O R I F F I C.

Similar posts: clinical oncology

Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) announced the initiation of a phase 1 dose-escalation clinical study of its prostate-specific membrane antigen (PSMA) antibody-drug conjugate (ADC). PSMA ADC is an investigational therapy that combines a prostate-cancer antibody with a cancer drug. Unlike traditional chemotherapy, PSMA ADC is designed to deliver the drug selectively to prostate cancer cells by targeting a surface protein, PSMA. The clinical study will include patients with progressive, metastatic, hormone-refractory disease following prior taxane chemotherapy, and will assess the safety, tolerability and initial clinical activity of PSMA ADC followed by the option to continue therapy for a total of 12 months.
In pre-clinical studies, PSMA ADC has exhibited a high level of tumor-specific activity, said Paul J. Maddon, M.D., Ph.D., Progenics Pharmaceuticals Founder, Chief Executive Officer and Chief Science Officer. Now, our first-in-man clinical studies will assess initial anti-tumor activity in patients after 12 weeks and subsequently, with an optional follow-up period, provide up to one year of dosing information.
Antibody-drug conjugate therapy
PSMA ADC is an antibody-drug conjugate that consists of a fully human monoclonal antibody that binds PSMA and is linked to a highly potent cancer drug, a derivative of auristatin.
The monoclonal antibody portion of PSMA ADC selectively targets PSMA, a protein that is abundantly expressed on the surface of prostate cancer cells. Using technology licensed from Seattle Genetics, Inc. (Nasdaq: SGEN), the fully human PSMA antibody is linked to a potent derivative of auristatin, a cancer drug that inhibits cell proliferation by disrupting the cellular (i.e., microtubules) required for replication. The resultant antibody-drug conjugate attaches to the PSMA protein on the surface of prostate cancer cells and is designed to:
- internalize the antibody-drug conjugate into the cancer cell;
- release and thereby activate the cancer drug; and
- destroy the malignant cell.
The cancer drug is chemically linked to the antibody and is designed to activate only after the antibody recognizes a cancer cell.
Two-stage clinical study design
The phase 1, open-label, dose-escalation clinical trial will include as many as 40 men with progressive, hormone-refractory prostate cancer, and who had prior therapy with taxane chemotherapy drugs. The study will investigate the duration of clinical benefit derived from PSMA ADC treatment while also assessing the drugs safety and tolerability. The initial 12-week period will evaluate up to four intravenous doses of PSMA ADC over five dose levels, administered at three-week intervals. The study will include evaluations of pharmacodynamics, radiographic changes in tumor burden, and changes in prostate-specific antigen (PSA) and circulating tumor cell (CTC) values compared to baseline.
Following the 12-week period, patients will be offered, at their physicians discretion, the option to continue treatment for an additional 39 weeks with the same dose of PSMA ADC as administered in their initial cohort. Qualified subjects will receive up to 13 additional doses of study drug at three-week intervals.
Pre-clinical results
A pre-clinical study, presented at the AACR Annual Meeting in April, demonstrated that treatment with PSMA ADC improved survival in a mouse model of androgen-independent prostate cancer. Post-tumor implantation, the median survival for control mice was 57 days. In contrast, nine of 10 animals in the PSMA ADC treatment group survived until study end at 150 days. Notably, of these nine mice, seven had no measurable tumor at day 150. No overt toxicity was observed with PSMA ADC treatment in this preclinical animal model.
About PSMA
PSMA is a protein abundantly expressed on the surface of prostate cancer cells and on the neovasculature of many types of solid tumors. PSMA expression is increased in high-grade, metastatic and hormone-refractory prostate cancer. Since PSMA has limited expression on normal tissues, it is an excellent therapeutic target.
Progenics is engaged in two programs that target PSMA for the treatment of prostate cancer. In addition to developing PSMA ADC, the Companys second program pursues vaccines that are designed to augment the bodys ability to recognize and eradicate cancer cells that express PSMA.
About Prostate Cancer
Prostate cancer is the most common form of cancer affecting men in the United States and is the second leading cause of cancer deaths among men each year. The American Cancer Society estimates that 234,000 new cases of prostate cancer will be diagnosed and that 30,000 men will die from the disease nationwide during 2008.
About the License Agreement
A collaboration agreement between Progenics Pharmaceuticals wholly owned subsidiary, PSMA Development Company (), and Seattle Genetics, Inc. () provides a worldwide license to SGs proprietary antibody-drug conjugate (ADC) technology. PDC has the exclusive right to use the ADC technology to link drugs to monoclonal antibodies that target PSMA.
PDC is responsible for research, product development, manufacturing and commercialization of all products under the agreement. It is also responsible for payments upon the achievement of certain milestones and for royalties to SG on net sales of a resulting commercialized product with SGs ADC technology. Treatment of the first patient in Progenics Pharmaceuticals phase 1 trial of PSMA ADC triggers a milestone payment from Progenics to SG.
About the Company
Progenics Pharmaceuticals, Inc., of Tarrytown, NY, is a biopharmaceutical company focusing on the development and commercialization of innovative therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases. Principal programs are directed toward gastroenterology, virology-including human immunodeficiency virus (HIV) and hepatitis C virus (HCV) infections-and oncology. Progenics, in collaboration with Wyeth, is developing RELISTOR (methylnaltrexone bromide) for the treatment of opioid-induced side effects. In the U.S., RELISTOR (methylnaltrexone bromide) subcutaneous injection is indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. In Canada, RELISTOR (methylnaltrexone bromide injection) for subcutaneous use is indicated for the treatment of OIC in patients with advanced illness receiving palliative care. In European member states, Iceland, Norway and Liechtenstein, RELISTOR (methylnaltrexone bromide) subcutaneous injection is indicated for the treatment of OIC in patients with advanced illness who are receiving palliative care, when response to the usual laxative therapy has not been sufficient. Marketing applications are pending for RELISTOR in Australia and other countries. In the area of virology, Progenics is developing the HIV entry inhibitor PRO 140, a humanized monoclonal antibody targeting the entry co-receptor CCR5, which has completed phase 1b clinical studies with positive results. PRO 140 is currently in phase 2 clinical testing. Pre-clinical programs for the development of novel HCV entry inhibitors are also underway. In the area of oncology, the Company is developing a human monoclonal antibody-drug conjugate (ADC) for the treatment of prostate cancer -a selectively targeted cytotoxic antibody directed against prostate-specific membrane antigen (PSMA). PSMA is a protein found on the surface of prostate cancer cells as well as in blood vessels supplying other solid tumors. Progenics is also developing vaccines designed to treat prostate cancer by stimulating an immune response to PSMA.
http://www.progenics.com
Disclosure Notice This document contains statements that do not relate strictly to historical fact, any of which may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. When we use the words and similar expressions, we are identifying forward-looking statements.
Forward-looking statements involve known and unknown risks and uncertainties which may cause our actual results, performance or achievements to be materially different from those expressed or implied by forward-looking statements. While it is impossible to identify or predict all such matters, this may result from, among other things, the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products and product candidates, including the risks that clinical trials will not commence or proceed as planned; products appearing promising in early trials will not demonstrate efficacy or safety in larger-scale trials; clinical trial data on our products and product candidates will be unfavorable; our products will not receive marketing approval from regulators or, if approved, do not gain sufficient market acceptance to justify development and commercialization costs; we, our collaborators or others might identify side effects after the product is on the market; or efficacy or safety concerns regarding marketed products, whether or not originating from subsequent testing or other activities by us, governmental regulators, other entities or organizations or otherwise, and whether or not scientifically justified, may lead to product recalls, withdrawals of marketing approval, reformulation of the product, additional pre-clinical testing or clinical trials, changes in labeling of the product, the need for additional marketing applications, declining sales or other adverse events.
We are also subject to risks and uncertainties associated with the actions of our corporate, academic and other collaborators and government regulatory agencies; potential product liability; intellectual property, litigation, environmental and other risks; the risk that licenses to intellectual property may be terminated for our failure to satisfy performance milestones; the risk of difficulties in, and regulatory compliance relating to, manufacturing products; and the uncertainty of our future profitability.
Risks and uncertainties also include general economic conditions, including interest and currency exchange rate fluctuations and the availability of capital; changes in generally accepted accounting principles; the impact of legislation and regulatory compliance; the highly regulated nature of our business, including government cost-containment initiatives and restrictions on third-party payments for our products; trade buying patterns; the competitive climate of our industry; and other factors set forth in our Annual Report on Form 10-K and other reports filed with the U.S. Securities and Exchange Commission. In particular, we cannot assure you that RELISTOR will be commercially successful or be approved in the future in other formulations, indications or jurisdictions, or that any of our other programs will result in a commercial product.
We do not have a policy of updating or revising forward-looking statements and assume no obligation to update any statements as a result of new information or future events or developments. Thus, it should not be assumed that our silence over time means that actual events are bearing out as expressed or implied in forward-looking statements.
Progenics Pharmaceuticals, Inc.

Similar posts: clinical oncology

Under terms of its collaboration with Opexa, the MRF will receive and analyze patient samples and clinical data from Opexas Phase IIb clinical study with Tovaxin to identify biomarkers related to safety and efficacy of the therapy in MS patients. As part of this analysis, the MRF will leverage its network of leading MS researchers, as well as its proprietary biochemical and biological assays which are designed for the discovery and characterization of novel biomarkers that may have clinical use in diagnosing and/or treating MS.
Through our collaboration with Opexa and our analysis of patient samples from the Tovaxin Phase IIb study, we hope to discover novel therapeutic, diagnostic and surrogate biomarker targets of components and pathways involved in the destruction, repair and re-myelination of axons in the central nervous system, said Russell Bromley, chief operating officer of the MRF. Research has shown that MS attacks individual patients differently. Accordingly, we expect that clinical samples from this study, in which T-cell vaccines were tailored for each subject, will help us better understand how we can identify specific myelin repair therapeutic targets to assist in the rapid development and commercialization of personalized MS treatments.
The collaboration will be jointly managed by research and development experts from Opexa and the MRF. Under terms of the agreement, each party will own all program intellectual property that is conceived of solely by its representatives. Intellectual property that is conceived of collaboratively will be jointly owned by both Opexa and the MRF with Opexa retaining the option to negotiate an exclusive license for any of the collaborations joint intellectual property or that which is solely owned by the MRF.
The MRF is a non-profit medical research foundation dedicated to accelerating basic medical research into myelin repair treatments aimed at dramatically improving the lives of people suffering from MS. The groups innovative Accelerated Research Collaboration(TM) (ARC) model involves the establishment of collaborations with a number of leading MS researchers at prestigious institutions who agree to work jointly to develop and conduct experiments that will lead to targeted myelin repair discoveries. To date, the MRF has entered into collaborations with researchers at Stanford University, Northwestern University, University of Chicago and Case Western Reserve University.
Organizations such as the MRF are critical to the discovery and development of safe and effective MS therapies, and data generated from the MRFs analysis of the patient samples from our Phase IIb Tovaxin study will provide valuable insight into the treatment of the disease, stated Jim Williams, Ph.D., chief operating officer of Opexa. Together with the MRF, we have the potential to uncover breakthroughs in an area of important medical research, discover additional promising MS therapies for development under Opexas T-cell platform, and gain invaluable data to guide the appropriate design of future clinical trials with Tovaxin to support future regulatory filings for the biologic.
Opexa is currently evaluating Tovaxin in 150 patients in a multi-center, randomized, double-blind, placebo-controlled Phase IIb clinical trial in patients suffering from Relapsing-Remitting Multiple Sclerosis (RRMS) or Clinically Isolated Syndrome (CIS). The company expects to announce top-line results from the Phase IIb study in September 2008.
About Tovaxin
Tovaxin is an autologous attenuated whole T-cell vaccine manufactured by specifically selecting Myelin Reactive T-Cells (MRTCs) from a patients blood and expanding them ex-vivo to a therapeutic dose. In this way, the vaccine is tailored to each patients disease state. The reintroduction of the attenuated T-cells via subcutaneous inoculation induces an immune response against the MRTCs, thereby triggering the immune system to attack the pathogenic T-cells in the body.
Opexa recently announced two-year follow-up data from its Phase I/II clinical studies. Data from 22 patients demonstrated that 73 percent of patients on Tovaxin remained relapse free after two years with 86 percent experiencing no disease progression. Tovaxin is manufactured in Opexas in-house cGMP facility.
About Opexa Therapeutics
Opexa Therapeutics develops and commercializes cell therapies to treat autoimmune diseases such as multiple sclerosis (MS) and diabetes. The Company is focused on autologous cellular therapy applications of its proprietary T-cell and stem cell therapies. The Companys lead product is Tovaxin, a T-cell therapy for MS which is in Phase IIb trials. The Company holds an exclusive worldwide license for adult multipotent stem cells derived from mononuclear cells of peripheral blood. The technology allows large quantities of monocyte-derived stem cells to be produced efficiently for use in autologous therapy, thus circumventing the threat of rejection. The Company is in the preclinical stages of the development of insulin-producing monocyte-derived islets as a replacement therapy for diabetes mellitus. For more information visit the Opexa Therapeutics website at www.opexatherapeutics.com.
About the Myelin Repair Foundation
The Myelin Repair Foundation (MRF) - http://www.myelinrepair.org - is a Northern California-based not-for-profit research foundation created to provide a collaborative environment in which leading research scientists at multiple universities, and experienced business executives, can work together to execute a five-year research plan - with milestones, parallel experiments, collaboration, and, most important, a constant focus on developing effective treatments for multiple sclerosis. Many believe MRFs Accelerated Research Collaboration model could change the way in which all medical research is conducted.
Cautionary Statement Relating to Forward - Looking Information for the Purpose of Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including statements about Opexa Therapeutics growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. These forward-looking statements are based on managements current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Opexa Therapeutics ability to obtain additional funding, develop its stem cell technologies, obtain FDA approval for its therapeutic products, achieve its operational objectives, and obtain patent protection for its discoveries, that may cause Opexa Therapeutics actual results to be materially different from any future results expressed or implied by such forward-looking statements. Opexa Therapeutics undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
Contact
Opexa Therapeutics, Inc.
Lynne Hohlfeld, 281-719-3421
lhohlfeld@opexatherapeutics.com
or
Vida Communication
Stephanie Diaz, 415-675-7400 (investors)
sdiaz@vidacommunication.com
or
Tim Brons, 415-675-7400 (media)
tbrons@vidacommunication.

Similar posts: clinical oncology

pSivida Corp. (NASDAQ:PSDV)(ASX:PVA)(FF:PSI), a global drug delivery company announced that a Phase IIb clinical trial has commenced with BrachySil™ (P32 BioSilicon™) as a potential new brachytherapy treatment for inoperable pancreatic cancer. The first patient has received treatment at Guys and St Thomas NHS Foundation Trust in London. A total of six patients will be entered into this trial at two centers in the UK (Guys and St Thomas NHS Foundation Trust, and University Hospital, Birmingham). The study will determine the safety of escalating radiation doses of the BrachySil™ device, with tumor response as a secondary end point.

Similar posts: clinical oncology

If youve been diagnosed with Type 2 diabetes, thats not youre only problem. Studies show that people afflicted with this disease tend to suffer more from other sicknesses.
Diabetics are more likely to come down with the flu, pneumonia, colds and other illnesses because their immune systems are compromised.
One of the most controversial and hugely popular health advice sources for diabetics is Kevin Trudeau.
The author of Natural Cures has found a strong following among Type 2s. Many of them dont like their doctors advice (and their doctors) and look for a non-pharmaceutical approach to control their disease.
Nutritional deficiencies are common in all of us, but to a greater extent in diabetics who need to bolster their immunity. Mr. Trudeau provides a list of steps you can follow for stronger protection against infection and illness:
#1Eat fresh organic vegetables and fruits
Eating fresh, uncooked fruits (4 servings) and vegetables (2 large servings) is recommended. Because naturally grown products do not contain the same amount of nutrients (due to soil depletion and pesticide use), the more servings, the better.
#2 Use a juice machine
3 to 4 glasses of fresh fruit and vegetable juice is recommended to provide living enzymes, vitamins and minerals needed to restore proper nutritional balance. These should be consumed in addition to the raw, uncooked fruits and vegetables noted above.
#3 Eat raw nuts and seeds
Raw or uncooked nuts and seeds provide a high nutritional content that should be eaten without roasting or salt. Almonds, pecans, sunflower seeds and others are some of the most nutritionally packed foods we can eat.
#4 Get natural sunlight
Vitamin D is derived from sun exposure. This nutrient has been found to help build immunity. 30 minutes a day is recommended. While research is still underway, Vitamin D deficiencies are becoming recognized as the source of much disease.
#5 Eat an organic apple every day
Considered a superfood, research is showing that the age old adage (An apple a day keeps the doctor away) is true. Trudeau recommends organic apples.
#6 Take calcium from some good source link coral calcium
Restores calcium to your system. For information find an excellent health food store and the smartest salesperson in the store.
#7 Take Vitamin E
Vitamin E has been credited with lowering the incidence of heart disease and other maladies. The natural d-alpha form should be taken, instead of the synthetic version.
#8 Take liquid colloidal minerals
These minerals help you to overcome food nutrition deficiencies.
#9 Drink Magic Juices
Trudeau stresses the importance of juice, particularly goji, acai berry, noni, mangosteen and aloe vera. Known as super-nutrient rich, you should drink these fresh, if possible. They contain a high level of nutrients and anti-oxidants. Goji berries and their juice, are particularly high on the anti-oxidant scale.
#10 Take a whole food supplement
Called concentrated real food rather than synthetic vitamins and minerals, these contain supplemental insurance that your body is getting nutrients often missing from food. Some supplements are focused on supporting diabetics in normalizing blood sugar levels and lowering weight to meeting natural BMI index targets.
Beyond Kevin Trudeaus Top 10 list, he also suggests that you eat organic honey, get an oxygen water cooler, take digestive enzymes, use organic sea salt, eat organic dark chocolate and take an omega-3 supplement.
The point of these tips is that the food and beverages we drink are often low or totally deficient in nutrients. Lack of nutrients in our bodies helps create the potential for disease and illness to occur. And we need to ward off these diseases with proper nutritional supplements.
Its important to note, that although it doesnt make Trudeaus Top 10 list, food ingredients, such as high fructose corn syrup, should be avoided at all costs.
High fructose corn syrup (HFCS) is added to most processed foods and beverages that we consume. Not only is it lacking in nutritional value, its more calorie dense than sugar and causes a blood sugar imbalance - two common diabetic problems that must be controlled.
Following Kevin Trudeaus Natural Cures advice of what to eat and drink is important. Its also important to watch what not to eat and drink, so that we overcome the effects of the diabetic condition.

Article Directory Source:
Type 2 diabetics and pre-diabetics are more prone to sickness than others.Natural Cures author Kevin Trudeau recommends ten tips to stay healthy.
ProvenResultsHealth Diab-x http://www.provenresultshealth.com/ Please visit us to learn more about how the natural, herbal ingredients in Diab-X help by promoting normal blood sugar levels, healthy body weight BMI, proper insulin function.

Similar posts: clinical oncology

A report released yesterday by the Center for Public Integrity, Perils of the New Pesticides, distorts the truth about the health effects of chemicals in pest management products, according to the Consumer Specialty Products Association (CSPA). Of specific concern is the authors misinterpretation of data collected by the U.S. Environmental Protection Agencys incident reporting system related to pyrethrins, natural insecticides produced by certain species of the chrysanthemum plant, and its synthetic counterparts, pyrethroids. By improperly using EPA data and drawing faulty conclusions from it, the report has needlessly caused alarm about both ingredients which have been used in pesticide products for decades.
CSPA points out that EPAs incidence data base can be a useful indicator of the consumer experience with products only to the extent that the data have been carefully evaluated and considered in the context of the limitations of the incident reporting system and with regard to extensive use of the products being studied. CPI took a simplistic approach that failed in this regard.
CSPA further notes that the data includes every type of case represented in raw data form, such as misuse, abuse, and exposures resulting from attempts at self harm such as suicides. No incident is required to undergo investigation, confirmation or validation before being added to the EPAs raw dataset.
The basic premise behind the authors paper that incident data in its raw form is signaling a serious health threat by these ingredients is fundamentally flawed, said Chris Cathcart, CSPA President. There was no evaluation by expert clinical and medical toxicologists to sort out incidents that, under further scrutiny by EPAs team of expert toxicologists and medical professionals, would have been excluded from the raw data set to allow for a meaningful analysis.
In the spirit of cooperation, CSPA facilitated more than ten hours of interview time with nationally recognized scientific and medical experts in the area of pyrethrins, pyrethroids and incidence reporting with the Center for Public Integrity. One of these experts has been involved with the EPAs reporting structure for incident data since its inception. That expert cautioned the author against drawing conclusions from the dataset that simply could not be supported from a scientific and medical basis given its inherent limitations.
Clearly, the CPI chose not to invest the time and energy necessary to conduct a thorough analysis, and the result is a seriously flawed report that merely serves to spread misinformation about products that have served consumers well for decades, said Cathcart. Because of their superior safety profile, pyrethrins and pyrethroids have been the replacement ingredients of choice following the removal of chlorpyrifos and other organophosphates from the marketplace. Pyrethrins and pyrethroids have helped to provide public health benefits by controlling pests that can transmit to humans diseases such as Lyme disease and West Nile virus.
About CSPA
The Consumer Specialty Products Association is a non-profit national trade association representing approximately 250 companies engaged in the manufacture, formulation, distribution and sale of hundreds of familiar consumer products. It is organized into seven divisions: Aerosol Products, Air Care, Antimicrobial Products, Cleaning Products, Pest Management Products, Industrial and Automotive Specialty Chemicals, and Polishes and Floor Maintenance. For more information, please visit http://www.cspa.

Similar posts: clinical oncology

ASTRO is pleased to announce the launch of its all-new patient Web site located at www.rtanswers.org. The site is dedicated to providing knowledge on radiation therapy treatment for people suffering with cancer. RT Answers includes up-to-date information on many diseases commonly treated with radiation therapy, including brain tumors, breast cancer, colorectal cancer, gynecologic cancers, head and neck cancer, Hodgkins lymphoma, lung cancer, non-Hodgkins lymphoma, prostate cancer and skin cancer. In addition, the site offers a section on understanding clinical trials and a list of questions patients can ask their doctors. RT Answers also adds valuable new information on what to expect before, during and after radiation therapy as well as a search function to allow patients to find a radiation oncologist in their area.

Similar posts: clinical oncology

Similar posts: clinical oncology

The best top 10 >>> clinical oncology

Americano new top 10 >>> clinical oncology

More info about >>> clinical oncology

Top 10 >>> clinical oncology

The best top 10 >>> clinical oncology

News the best top 10 >>> clinical oncology

Americano new top 10 >>> clinical oncology

See more: >>> clinical oncology

Americano new top 10 >>> clinical oncology

Top 10 >>> clinical oncology

ModernMedicine is an innovative new online resource designed to meet the evolving needs of physicians, nurses and other allied healthcare professionals. This intuitive and clinically practical website brings together elements from 17 of Advanstar Communication's trusted healthcare delivery publications along with powerful tools, resources, decision support and advisory functions that address your daily needs.

Top 10 >>> clinical oncology