Researchers at the University of Texas M.D. Anderson Cancer Center are using donations of umbilical cord blood — which is quickly “emerging as an alternative to treat” at least 50 diseases such as cancer, cell anemia and Tay-Sachs disease — to help offset a “shortage of transplant material for minority patients,” the Houston Chronicle reports. Bone marrow and cord blood contain stem cells that can transform into blood or immune cells and can be particularly important in reconstituting a patient’s blood supply after chemotherapy or radiation, according to the Chronicle.

According to data from the National Marrow Donor Program, each year more than 6,000 people in the U.S. are unable to find suitable bone marrow donations, and the majority of them are minorities. Finding bone marrow matches for minorities is “more difficult” because “genes are more diverse” among blacks, Hispanics and Asian-Americans, according to the Chronicle. Blacks, for example, have a 10% chance of finding a match, according to the Chronicle.

For a successful donation, a minimum of six particular bone marrow genes must match between the donor and patient. However, when cord blood is used instead of bone marrow, only four of the six genes need to match. While bone marrow transplants still are more common than cord blood transplants, the number of cord blood transplants worldwide has more than tripled in the last few years, according to Elizabeth Shpall, director of M.D. Anderson’s cord blood bank and a professor of stem cell transplantation and cellular therapy.

M.D. Anderson in 2005 began a campaign to increase minority cord blood donations, aiming to collect more than 60% of cord blood donations from racial and ethnic groups. Minorities now make up more than 70% of cord blood donations, compared with about 50% in 2005, the Chronicle reports.

Researchers said the campaign is responsible for high donations from Hispanics. Before the effort, about one-third of Hispanics declined the opportunity to donate cord blood — mainly because of religious reasons and a fear that cord blood would be used for cloning — though the refusal rate now is about 10%.

Richard Champlin, chair of M.D. Anderson’s department of stem cell transplantation and cellular therapy, said, “Cord blood possibly could eventually replace bone marrow one day,” adding that researchers “still like a perfect match from the patient’s family member, but innovations could change that” (Ackerman, Houston Chronicle, 3/24).

Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved. Continue reading →

Three-year data from
the largest, multi-center, prospective voluntary registry on any procedure
for benign uterine fibroids showed that 90 percent of the women
participating avoided a hysterectomy and of these, 85 percent had a
substantial improvement in symptoms and quality of life. The registry
included three-year data on 1,278 patients from 26 sites who had this
minimally invasive interventional radiology treatment for symptomatic
fibroids, showing uterine fibroid embolization is a durable treatment for
fibroids with sustained improvement in quality of life and symptom relief.
Twenty to 40 percent of American women age 35 and older, and nearly 50
percent of pre-menopausal African American women, have uterine fibroids. Of
the 600,000 hysterectomies performed annually in the United States,
one-third of these are to relieve symptoms caused by fibroids. “This
registry data is great news for women. With uterine fibroid embolization,
we could significantly decrease the hysterectomy rate in the United States”
says Scott Goodwin, MD, interventional radiologist and lead author.

Uterine fibroids are benign tumors that can cause prolonged, heavy
menstrual bleeding that can be severe enough to cause anemia or require
transfusion, disabling pelvic pain and pressure, urinary frequency, pain
during intercourse, miscarriage, interference with fertility, and an
abnormally large uterus resembling pregnancy. UFE is a minimally invasive
interventional radiology treatment that blocks the blood supply to the
fibroid tumors, causing them to shrink and die, and symptoms to subside.

The FIBROID Registry was designed to follow the “real world” outcomes
for uterine fibroid embolization as it became a mainstream treatment widely
available across the country. The purpose of the Registry was to assess the
procedure’s effectiveness in improving fibroid-related symptoms, to
determine the durability of those improvements, and to assess the safety of
the procedure in broad practice. The 1,278 women who completed the
three-year follow-up had significant improvement in symptoms and in quality
of life (QOL), moving them into the normal range on this validated survey
instrument. The mean symptom scores before embolization were 58.61, and
post-procedure at three years were 16.54. Mean QOL scores pre-embolization
were 46.95 and at three years were 89.55. Eighty-five percent would
recommend the procedure to a family member or friend. The study also
identified subgroups of patients that appeared to have a greater likelihood
of improvement.

This data shows that the long-term clinical outcomes of UFE are
consistent when the procedure is performed in any experienced community or
academic interventional radiology practice. “The Registry’s outcomes are
important not only because of its size, but also because of the diversity
of sites that participated. These results demonstrate that uterine fibroid
embolization is safe and very effective beyond the academic or specialized
centers.” The Registry is one of the few efforts ever undertaken to study
the efficacy of a procedure as it disseminates into broad practice, and
this is the first such effort for a fibroid therapy by any specialty.

“It is important for women to know all of their treatment options in
order to make an informed decision. Interventional radiologists can provide
a second opinion and assess whether UFE is a treatment option. The vast
majority of women are eligible for this treatment,” says Goodwin.
Interventional radiologists use MRI to delineate the location of each
fibroid, determine if a tumor can be embolized, detect alternate causes for
the symptoms, identify pathology that could prevent a woman from having
UFE, and avoid ineffective treatments. The number of women requiring
retreatment after UFE in the registry is similar to the surgical
reintervention rates, of approximately five percent per year, following
myomectomy.

About Uterine Fibroid Embolization

Uterine fibroid embolization is performed by interventional
radiologists, physicians who are fellowship trained in minimally invasive
treatments. Embolization is a common interventional radiology treatment for
benign and cancerous tumors. In uterine fibroid embolization, the
interventional radiologist makes a tiny nick in the skin, about the size of
a pencil tip, and inserts a catheter into the femoral artery. Using
real-time imaging, the physician guides the catheter up the artery and then
releases tiny particles, the size of grains of sand, into the blood vessels
feeding the fibroid, cutting off its blood supply, causing it to shrink and
die, and symptoms to subside. Most women return home the next day and can
resume normal activities, with an average full recovery time of seven to 10
days.

About the Society of Interventional Radiology Foundation

The SIR Foundation is a scientific foundation dedicated to fostering
research and education in interventional radiology for the purposes of
advancing scientific knowledge, increasing the number of skilled
investigators in interventional radiology, and developing innovative
therapies that lead to improved patient care and quality of life.

Interventional radiologists are physicians who specialize in minimally
invasive, targeted treatments. They offer the most in-depth knowledge of
the least invasive treatments available coupled with diagnostic and
clinical experience across all specialties. They use X-rays, MRI and other
imaging to advance a catheter in the body, usually in an artery, to treat
at the source of the disease nonsurgically. As the inventors of angioplasty
and the catheter-delivered stent, which were first used in the legs to
treat peripheral arterial disease, interventional radiologists pioneered
minimally invasive modern medicine.

Society of Interventional Radiology
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Incorporating testing for human papillomavirus (HPV) DNA into cervical cancer screening has the potential for improving
health benefits at a reasonable cost in France, Italy, the Netherlands, and the United Kingdom, according to a new study in
the June 15 issue of the Journal of the National Cancer Institute.

Cervical cancer screening has been shown to decrease mortality from the disease. The discovery that HPV infection is the
cause of most cervical cancers has led to some countries to incorporate HPV DNA testing into national screening programs. For
example, in the United States, HPV testing is used as both a triage strategy in the case of uncertain Pap test results and in
combination with cytology in women older than age 30. Many European countries with established cytology-based cervical cancer
screening programs will soon face the decision of whether to incorporate HPV DNA testing into their programs and which
strategies will be the most cost-effective.

To assess the cost-effectiveness of incorporating HPV DNA testing into the cervical cancer screening programs of France,
Italy, the Netherlands, and the United Kingdom, Jane J. Kim, M.S., and Sue J. Goldie, M.D., M.P.H., of the Harvard School of
Public Health in Cambridge, Mass., and Thomas C. Wright, M.D., of Columbia University in New York, created a computer-based
model of the natural history of cervical carcinogenesis and compared each country’s current screening policy with two new
strategies: (1) cytology (i.e., Pap tests) throughout a woman’s lifetime with HPV DNA testing as a triage strategy for
abnormal cytology results and (2) cytology until age 30 followed by HPV DNA testing in combination with cytology after age
30.

Both HPV DNA testing strategies were more effective than each country’s current cytology-based screening program. The
cost-effectiveness ratios for the triage strategy were less than $13,000 per year of life saved in all four countries. For
the combination testing strategy, the cost-effectiveness ranged from $9,800 to $75,900 per year of life saved, depending on
the screening interval. The authors conclude that HPV DNA testing can improve health benefits at a reasonable cost in the
four countries studied.

“The development of sound clinical guidelines and public health policy requires careful consideration of the incremental
benefits, harms, and costs that are associated with new technology and its adoption into existing screening strategies,
compared with the status quo,” the authors write. “As a result of the rapid infusion of new technologies for cervical cancer
screening, there is an increased need for policy evaluation to guide such investments.”

Contact: Kevin Myron, Communications, Harvard School of Public Health, 617-432-3952, kmyronhsph.harvard

Citation: Kim JJ, Wright TC, Goldie SJ. Cost-effectiveness of Human Papillomavirus DNA Testing in the United Kingdom, The
Netherlands, France, and Italy. J Natl Cancer Inst 2005;97:888-95.

Note: The Journal of the National Cancer Institute is published by Oxford University Press and is not affiliated with the
National Cancer Institute. Attribution to the Journal of the National Cancer Institute is requested in all news coverage.
Visit the Journal online at jncicancerspectrum.oupjournals.

Contact: Sarah Zielinski
jncimediaoupjournals
301-841-1287
Journal of the National Cancer Institute
jncicancerspectrum.oupjournals Continue reading →

The British Dental Association has called for action from the Scottish Government Health Department (SGHD) after new figures revealed that almost a third of dental practices across Scotland that provide NHS treatment do not qualify as being committed to the NHS. The latest figures from NHS Practitioner Services Division, which relate to the quarter ending March 2008, show that almost 30 per cent (29.5 per cent) of the 879 practices providing NHS care in Scotland are not deemed to be committed.

The current criteria, imposed as part of the Dental Action Plan introduced in April 2005, mean that dentists whose NHS lists are focused on children or socially deprived members of society do not qualify as committed. Nor do those whose number of NHS patients reduces significantly. Practices not deemed to be committed are not eligible to receive the full General Dental Practice Allowance or rent reimbursement payments from NHS Scotland intended to retain dentists in the NHS. The BDA has lobbied strenuously for the qualifying criteria to be reconsidered.

Derek Harper, Vice Chair of the BDA’s Scottish Dental Practice Committee, said:
“It is now more than three years since the introduction of the Dental Action Plan, with its promise to improve access to NHS dentistry. That promise has not been kept.

“The action plan also introduced the flawed definition of commitment that means a significant number of dentists providing a large amount of NHS care still aren’t recognised as being committed to the NHS. The BDA urges the current administration to reconsider the folly of its predecessor and work with dentists’ representatives to develop an equitable solution to this problem that is in the best interests of patients and that would encourage retention of dentists in the NHS.”

– The definition of commitment to the NHS that the Scottish Executive has implemented means that unless a dentist treats a minimum of 500 patients, they are not considered to be committed to the NHS and are not be eligible for new allowances arising out of the Scottish Executive Health Department’s Action Plan. Dentists must also treat a minimum number of 100 adult fee-paying patients and gross ??50,000 per annum to qualify. Furthermore, reducing the number of NHS patients being treated by more than 10% can also lead to a practice being deemed to be uncommitted.

– The definition leads to a number of anomalies. For instance, a practice treating 500 NHS patients and maintaining that number will be deemed to be committed, while a practice that initially treats 1,400 NHS patients but reduces its NHS list to 1,200 will be deemed not to be committed. Similarly, a practice that treats 1,500 children as NHS patients, but less than 100 adult fee-paying patients is also deemed not to be committed.

The British Dental Association (BDA) is the professional association for dentists in the UK. It represents over 20,000 dentists working in general practice, in community and hospital settings, in academia and research, and in the armed forces.

British Dental Association Continue reading →

Boston Scientific Corporation (NYSE: BSX) today announced the international launch and first implantation of the PROMUS Everolimus-Eluting Stent, making Boston Scientific the only company to offer two distinct drug-eluting stent (DES) platforms. PROMUS is a private-labeled XIENCE V Everolimus-Eluting Coronary Stent System manufactured by Abbott and distributed by Boston Scientific. The PROMUS stent received CE Mark approval in October 2006 which allows Boston Scientific to distribute it in 27 countries of the European Economic Area. It will also be available in selected countries in Asia, Latin America and Eastern Europe. ? A U.S. launch is planned for 2008.? 

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Dr. Willibald Maier performed the procedure on December 21, 2006 at University Hospital in Z??rich, Switzerland, marking the first implantation of the PROMUS stent.

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“I am excited to have been a part of the first use of Boston Scientific’s new drug-eluting stent,” said Dr. Maier, “The PROMUS stent provides patients with a treatment option that offers an Olimus drug on a highly deliverable platform and we are pleased to have it available for our patients.”

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“The addition of the PROMUS stent gives Boston Scientific the ability to offer clinicians two highly deliverable options – our market-leading TAXUS™ Paclitaxel-Eluting Stent and PROMUS, our high-potential Everolimus-Eluting Stent,” said Paul LaViolette, Chief Operating Officer of Boston Scientific. “The PROMUS stent complements our broad DES portfolio and further reinforces the leadership of Boston Scientific in the DES market as well as our commitment to continued innovation.”

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Positive results for the PROMUS stent were reported from the SPIRIT II clinical trial at the World Congress of Cardiology in Barcelona, Spain, demonstrating that the PROMUS stent met its primary endpoint of non-inferiority to the TAXUS stent as measured by late loss at six months.?  Boston Scientific’s TAXUS Stent System has a record of proven outcomes, including three million TAXUS stents implanted in patients worldwide and clinical follow-up on more than 4,000 patients out to four years.

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PROMUS and TAXUS are trademarks of Boston Scientific Corporation or its affiliates. ? XIENCE is a trademark of Abbott. The SPIRIT Clinical Program is sponsored by Abbott.?  The PROMUS stent is not approved for sale in the U.S.

? 
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devises whose products are used in a broad range of interventional medical specialties.?  For more information, please visit: boston.scientific.

? 
This press release contains forward-looking statements.?  Boston Scientific wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with new product development and commercialization, clinical trials, intellectual property, regulatory approvals, competitive offerings, Boston Scientific’s over all business strategy, and?  other factors described in Boston Scientific’s filings with the Securities?  and Exchange Commission. Continue reading →

GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX index; Nasdaq: GPCB) today announced that the Company has submitted the non-clinical section of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for satraplatin in combination with prednisone as a second-line chemotherapy
treatment for patients with hormone-refractory prostate cancer (HRPC). The
Company submitted the chemistry, manufacturing and controls — or CMC –
section of the NDA in December 2005 and anticipates completing the NDA
submission by the end of 2006.

“The non-clinical section is the second of three parts necessary to
complete the NDA submission. We are very pleased that we continue to make
such good progress in advancing satraplatin toward the market and that we
remain on track with our timelines,” said Bernd R. Seizinger, M.D., Ph.D.,
Chief Executive Officer. “The second half of 2006 promises to be of seminal
importance for GPC Biotech as we expect to have the final data on
progression- free survival from our SPARC registrational trial in the fall
and complete the NDA filing by the end of this year.”

The FDA granted “fast track” designation to satraplatin as a
second-line chemotherapy treatment for patients with HRPC in September
2003. The FDA’s fast track programs are intended to expedite the review of
drugs to treat serious or life-threatening conditions and that demonstrate
the potential to address unmet medical needs.

The rolling submission process enables companies that have been granted
fast track designation to submit sections of the NDA to the agency as they
become available, allowing the review process to begin before the complete
dossier has been submitted.

About Satraplatin

Satraplatin, an investigational drug, is a member of the platinum
family of compounds. Over the past two decades, platinum-based drugs have
become a critical part of modern chemotherapy treatments and are used to
treat a wide variety of cancers. Unlike the platinum drugs currently on the
market, all of which require intravenous administration, satraplatin is an
orally bioavailable compound and is given as capsules that patients can
take at home.

In December 2005, GPC Biotech completed accrual to the SPARC trial that
is evaluating satraplatin in combination with prednisone as second-line
chemotherapy in patients with hormone refractory prostate cancer. Also in
December 2005, GPC Biotech initiated the rolling submission of an NDA for
satraplatin with the FDA. The Company has a co-development and license
agreement with Pharmion GmbH, a wholly owned subsidiary of Pharmion
Corporation, under which Pharmion has been granted exclusive
commercialization rights to satraplatin for Europe and certain other
territories.

Satraplatin has been studied in clinical trials involving a range of
tumors, and Phase 2 trials have been completed in hormone-refractory
prostate cancer, ovarian cancer and small cell lung cancer. Other trials
evaluating the effects of satraplatin in combination with radiation
therapy, in combination with other cancer therapies and in various other
cancers are underway or planned. GPC Biotech in-licensed satraplatin from
Spectrum Pharmaceuticals, Inc. in 2002. Additional information on
satraplatin can be found in the Anticancer Programs section of the
Company’s Web site at gpc-biotech/.

About GPC Biotech

GPC Biotech AG is a biopharmaceutical company discovering and
developing new anticancer drugs. The Company’s lead product candidate -
satraplatin – has achieved target enrollment in a Phase 3 registrational
trial as a second-line chemotherapy treatment in hormone-refractory
prostate cancer. The U.S. FDA has granted fast track designation to
satraplatin for this indication, and GPC Biotech has begun the rolling NDA
submission process for this compound. GPC Biotech is also developing a
monoclonal antibody with a novel mechanism-of- action against a variety of
lymphoid tumors, currently in Phase 1 clinical development, and has ongoing
drug development and discovery programs that leverage its expertise in
kinase inhibitors. GPC Biotech AG is headquartered in Martinsried/Munich
(Germany). The Company’s wholly owned U.S. subsidiary has sites in Waltham,
Massachusetts and Princeton, New Jersey. For additional information, please
visit the Company’s Web site at gpc-biotech/.

This press release may contain forward-looking statements, including,
without limitation, statements about the progress and results of the
outcome of the SPARC trial and other clinical development activities,
regulatory processes and commercialization efforts for satraplatin.
Forward-looking statements are based on the Company’s current expectations
and projections about future events and are subject to risks, uncertainties
and assumptions in light of which the forward-looking events discussed in
this press release might not occur. We direct you to the Company’s Form
20-F for the fiscal year ended December 31, 2005 and other reports filed
with the U.S. Securities and Exchange Commission for additional details on
the important factors that may affect these statements and the Company’s
future results, performance and achievements. Readers are cautioned not to
place undue reliance on these forward-looking statements that speak only as
of the date of this release. Except as required by law, the Company does
not undertake any obligation to publicly update or revise any
forward-looking statements, whether as a result of new information, future
events or otherwise.

GPC Biotech AG
gpc-biotech/ Continue reading →

More than a million cancer survivors living in the United States are foregoing what they believe is necessary medical care due to the cost, and Hispanics and African-Americans are twice as likely to go without services, according to data presented at the American Association for Cancer Research conference on the Science of Health Care Disparities.

“These survivors are either going without, or significantly delaying, dental care, general medical care, mental health care or prescription drugs,” said Kathryn Weaver, Ph.D., a cancer prevention fellow at the National Cancer Institute.

Although insurance status did play a role, foregoing care due to cost still persisted among the insured. “There are significant out-of-pocket expenses, even for those with insurance,” said Weaver.

Weaver and colleagues used data from the Center for Disease Control’s National Health Interview Survey to identify 6,602 adult cancer survivors. Of these survivors, 64.3 percent were female, 4.8 percent were Hispanic, 6.4 percent were non-Hispanic black and 88.8 percent were non-Hispanic white. The survey is conducted annually and questions about 30,000 to 40,000 households.

Overall, the prevalence of foregoing medical care due to cost was 7.8 percent for general medical care, 9.9 percent for prescription medication, 11.3 percent for dental care and 2.7 percent for mental health care.

Compared to non-Hispanic whites, Hispanics were 2.14-fold more likely to forego prescription medications due to cost concerns and African-Americans were 87 percent more likely to forego prescriptions. For dental care, Hispanics were 2.31-fold more likely to go without and African-Americans were 57 percent more likely.

These differences persisted after statistical adjustments for education, health insurance coverage and non-cancer medical comorbidities.

“Efforts to expand insurance coverage might go some way toward addressing these problems, but absent that, clinicians need to be more aware that their patients are not getting these services and work to try to connect them to charity or low-cost care,” said Weaver.

The mission of the American Association for Cancer Research is to prevent and cure cancer. Founded in 1907, AACR is the world’s oldest and largest professional organization dedicated to advancing cancer research. The membership includes more than 28,000 basic, translational and clinical researchers; health care professionals; and cancer survivors and advocates in the United States and 80 other countries. The AACR marshals the full spectrum of expertise from the cancer community to accelerate progress in the prevention, diagnosis and treatment of cancer through high-quality scientific and educational programs. It funds innovative, meritorious research grants. The AACR Annual Meeting attracts more than 17,000 participants who share the latest discoveries and developments in the field. Special conferences throughout the year present novel data across a wide variety of topics in cancer research, treatment and patient care. The AACR publishes five major peer-reviewed journals: Cancer Research; Clinical Cancer Research; Molecular Cancer Therapeutics; Molecular Cancer Research; and Cancer Epidemiology, Biomarkers & Prevention. The AACR’s most recent publication and its sixth major journal, Cancer Prevention Research, is dedicated exclusively to cancer prevention, from preclinical research to clinical trials. The AACR also publishes CR, a magazine for cancer survivors and their families, patient advocates, physicians and scientists. CR provides a forum for sharing essential, evidence-based information and perspectives on progress in cancer research, survivorship and advocacy.

American Association for Cancer Research (AACR)
615 Chestnut St., 17th Fl.
Philadelphia
PA 19106
United States
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Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) announced that a
preclinical study being presented by an independent team of investigators
at the 2008 Annual Meeting of the American Association for Cancer Research
(AACR) further illustrates the broad anti-tumor potential of its
anti-phosphatidylserine (anti-PS) vascular targeting antibodies. The study
by Dr. Yayun Liang, Dr. Salman Hyder and colleagues at the University of
Missouri describes promising anti-cancer activity observed when a mouse
equivalent to the company’s Phase II anti-PS antibody bavituximab was
combined with an investigational agent that re-activates the tumor
suppressor p53, which is turned off in many tumors. Bavituximab is a
monoclonal antibody that is believed to work by selectively destroying the
blood vessels supporting tumor growth and spread and by reversing the
ability of tumors to suppress the body’s natural immune response.

“This study highlights the broad anti-cancer potential of our anti-PS
vascular targeting platform,” said Steven W. King, president and CEO of
Peregrine. “Numerous preclinical studies have shown the potential efficacy
of our anti-PS antibodies in combination with both existing and novel
therapies for the treatment of cancer. This new study further illustrates
the potential versatility of our anti-PS antibodies in combination cancer
therapy. We look forward to future clinical studies of bavituximab and
other anti-PS antibodies in a broad range of anti-cancer regimens.”

Dr. Liang and her colleagues reported on their study of a bavituximab
equivalent antibody, 2aG4, in combination with a clinical stage small
molecule agent, PRIMA-1. PRIMA-1 restores the normal function of mutant
forms of the tumor suppressor p53, enabling it to induce tumor cell death.
The combination therapy resulted in additive and synergistic anti-tumor
effects in two mouse models of advanced breast cancer, enhancing tumor
regression and elimination, while also reducing the incidence of lymph node
metastases in some subjects.

Dr. Liang noted, “These results indicate that PRIMA-1 plus 2aG4
combination therapy has a complementary and potent anti-tumor activity and
could define a new strategy for suppression of advanced breast cancers.”

Bavituximab is a monoclonal antibody that binds to a phospholipid
called phosphatidylserine that is usually located inside normal cells, but
which becomes exposed on the outside of the cells that line the blood
vessels of tumors, creating a specific target for anti-cancer treatments.
Bavituximab helps mobilize the body’s immune system to destroy the blood
vessels needed for tumor growth and spread. In a Phase lb pilot trial in
advanced cancer patients, bavituximab plus chemotherapy appeared to have a
safety profile consistent with chemotherapy alone and showed positive signs
of clinical activity, achieving objective response or disease stabilization
in 50% of the evaluable patients. Peregrine has received regulatory
approval to conduct three Phase II trials to study the anti-tumor effects
of bavituximab in combination with chemotherapy. These include two breast
cancer protocols and a non-small cell lung cancer protocol. One of the
bavituximab breast cancer trials is currently enrolling and dosing patients
and the two other trials are expected to begin shortly. Bavituximab is in
clinical trials in the U.S. in patients with advanced solid tumors and in
patients co-infected with HCV and HIV.

No. 2341: Yayun Liang, Salman M. Hyder, Cynthia L. Besch Williford,
Indira Benakanakere, Sandra L. Brandt, Philip E. Thorpe. Targeting mutant
p53 protein and tumor vasculature: An effective combination therapy for
advanced breast tumors, Univ. of Missouri, Columbia, MO, Simmons Cancer
Center, University of Texas Southwestern, Dallas, TX, April 14, 2008, 8:00
AM -12:00 PM PDT

About Peregrine Pharmaceuticals

Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a
portfolio of innovative product candidates in clinical trials for the
treatment of cancer and hepatitis C virus (HCV) infection. The company is
pursuing three separate clinical programs in cancer and HCV infection with
its lead product candidates bavituximab and Cotara(R). Peregrine also has
in-house manufacturing capabilities through its wholly owned subsidiary
Avid Bioservices, Inc. (avidbio), which provides development
and bio-manufacturing services for both Peregrine and outside customers.
Additional information about Peregrine can be found at
peregrineinc.

Safe Harbor Statement: Statements in this press release which are not
purely historical, including statements regarding Peregrine
Pharmaceuticals’ intentions, hopes, beliefs, expectations, representations,
projections, plans or predictions of the future are forward-looking
statements within the meaning of the Private Securities Litigation Reform
Act of 1995. The forward-looking statements involve risks and uncertainties
including, but not limited to, the risk that the company will experience
delays or difficulties in enrolling patients in the study, the risk that
results from future preclinical studies and clinical trials will not
correlate with the results of these preclinical studies and the risk that
bavituximab will not provide comparable results in combination with other
cancer therapies. It is important to note that the company’s actual results
could differ materially from those in any such forward-looking statements.
Factors that could cause actual results to differ materially include, but
are not limited to, uncertainties associated with completing preclinical
and clinical trials for our technologies; the early stage of product
development; the significant costs to develop our products as all of our
products are currently in development, preclinical studies or clinical
trials; obtaining additional financing to support our operations and the
development of our products; obtaining regulatory approval for our
technologies; anticipated timing of regulatory filings and the potential
success in gaining regulatory approval and complying with governmental
regulations applicable to our business. Our business could be affected by a
number of other factors, including the risk factors listed from time to
time in the company’s SEC reports including, but not limited to, the annual
report on Form 10-K for the year ended April 30, 2007 and the quarterly
report on Form 10-Q for the quarter ended January 31, 2008. The company
cautions investors not to place undue reliance on the forward-looking
statements contained in this press release. Peregrine Pharmaceuticals, Inc.
disclaims any obligation, and does not undertake to update or revise any
forward-looking statements in this press release.

Peregrine Pharmaceuticals, Inc.
peregrineinc Continue reading →

UroToday – How should patients with high-risk prostate cancer be optimally treated? In large part because of PSA screening, increasing numbers of patients are diagnosed with low risk, T1c disease. Yet, a significant number of patients continue to die of prostate cancer, with over 28,000 prostate cancer deaths estimated in the US for 2008 . Many of these prostate cancer deaths occur in patients who have high risk features noted at presentation. The Radiation Therapy Oncology Group (RTOG) has been interested in pursuing strategies aimed at this cohort of patients (Primarily Gleason score 8-10, with Gleason Score 7 and PSA > 20 at presentation also eligible).

A recent article, “Phase III Multi-Institutional Trial of Adjuvant Chemotherapy with Paclitaxel, Estramustine, and Oral Etoposide Combined with Long-Term Androgen Suppression Therapy and Radiotherapy Versus Long-Term Androgen Suppression Plus Radiotherapy Alone For High-Risk Prostate Cancer: Preliminary Toxicity Analysis of RTOG 99-02,” reported an attempt to improve survival rates in this cohort of patients. In this trial, the control arm was modeled after RTOG trial 92-02, where a regimen of 2 years of androgen suppression + RT was shown to produce improved survival rates when compared with a regimen of short term (4 months) of androgen suppression + RT for patients with Gleason Score 8-10 prostate cancers. This study has just been updated with 10 year follow-up in a recent report.

The rationale for this study involved the hypothesis that adding cytotoxic chemotherapy to the long term AS + RT regimen would improve survival rates by being used in an adjuvant fashion, after the initial period of AS +RT, in an effort to reduce the number of hormone refractory clones earlier in the disease process, rather than waiting for clinically apparent hormone refractory disease to develop.

A chemotherapy regimen of paclitaxel, estramustine, and etoposide was utilized. Almost 400 patients were accrued to the trail between 2000-2004 at institutions in North America. Unfortunately, the study closed early because of toxicity concerns related to the chemotherapy. Specifically there was excess thromboembolic toxicity thought to be related to the chemotherapy regimen, and most likely the agent estramustine. This report by Rosenthal et al. discusses the toxicity concerns and reports. It is too early to analyze efficacy endpoints from the study, although this analysis is planned for the future.

Although RTOG trial 99-02 closed prematurely because of toxicity concerns, a successor trial, RTOG 0521 , opened in 2005, and has accrued approximately 470 patients by December 2008. It uses the same basic schema, with a regimen of long-term (2 yrs) of AS + RT in the control arm, and AS+ RT with cytotoxic chemotherapy in the experimental arm. In this trial, the chemotherapy is delivered with docetaxel and prednisone, based on reports showing this regimen to be well tolerated and efficacious in hormone refractory disease. This trial is ongoing, and results are not available. It builds on the basis of RTOG 99-02. The report referenced here shows how an initial toxicity report from a protocol concept can be useful in guiding the development of subsequent studies.

The ongoing RTOG 0521 study, and subsequent analysis of the RTOG 99-02 study, will help to address the question of whether the use of cytotoxic chemotherapy earlier in the disease process will help to improve survival rates, when added to standard therapy, for gentlemen diagnosed with high-risk, but non-metastatic, prostate cancer.

References

Jemal, A, Siegel, R, Ward, E, et al: Cancer Statistics, 2008. CA Cancer J Clin 2008; 58:71-96.

Rosenthal SA, Bae K, Pienta KJ, Sobczak ML, Asbell SO, Rajan R, Kerlin KJ, Michalski JM, Sandler HM : Phase III Multi-Institutional Trial of Adjuvant Chemotherapy with Paclitaxel,Estramustine, and Oral Etoposide Combined with Long-Term Androgen Suppression Therapy and Radiotherapy Versus Long-Term Androgen Suppression Plus Radiotherapy Alone For High-Risk Prostate Cancer: Preliminary Toxicity Analysis of RTOG 99-02. Int J Radiat Oncol Biol Phys. 2008 Nov 4. [Epub ahead of print].

Horwitz, EM, Bae, K, Hanks, GE, Porter, A, Grignon, D, Brereton, H, Venkatesan, V, Lawton, C, Rosenthal, SA, Sandler, HM, and Shipley, WU: Ten-Year Follow-up of RTOG 92-02: A Phase III Trial of the Duration of Elective Androgen Deprivation in Locally Advanced Prostate Cancer. J Clin Oncol 26:2497-2504, 2008.

Radiation Therapy Oncology Group: RTOG 0521: A Phase III protocol of Androgen Suppression (AS) and 3DCRT/IMRT vs. AS and 3DCRT/IMRT followed by chemotherapy with docetaxel and prednisone for localized, high-risk, prostate cancer. rtog. rtog/members/protocols/0521/0521.pdf

Tannock, IF, deWit, R, Berry, WR, et al.: Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 2004;351:1502-1512.

Written by Seth A. Rosenthal, MD, FACR as part of Beyond the Abstract on UroToday

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Doctors from the Navarre University Clinic [Cl?­nica Universitaria de Navarra (CUN)] have developed an electronic alarm system that alerts doctors to the level of risk of thrombosis in hospitalised patients. The programme, which performs a daily evaluation of each hospitalised patient, is a way to solve the problem of the lack of preventive treatment.

“This system sets out a risk profile for venous thromboembolism in each patient and alerts the doctor as to whether he should apply preventive or prophylactic treatment”, Jos?© Antonio P??ramo, co-author of the research and a doctor at the CUN, explains to SINC.

This system has been described in the Thrombosis and Haemostasis journal, and achieves this by collecting information from each patient admitted to the clinic. This involves “their baseline disease, the drugs they are taking, their lifestyle such as smoking or obesity, and whether they are going to have surgery”, the researcher outlines. These variables form part of the Pretemed scale, a model that calculates the risk of venous thrombosis validated throughout Spain. Each of these factors is equivalent to a score that increases the likelihood of alert which, according to the expert, “already exists because of the mere fact of being admitted to hospital”.

During the patient’s stay in hospital, the system gradually calculates the risk of thrombosis according to the patient’s progress, by performing a daily evaluation of the medical risk factors or whether the patient has had surgery.

“When the score is low, physical measures are applied initially, such as the use of elastic stockings or early mobilisation, but when the score is higher than 4, thrombosis must be avoided by administering low weight molecular heparin”, the doctor clarifies. “It is not that the system imposes prophylactic treatment, but when a patient’s score is high it alerts the doctor by sending a message, and he is the person who decides whether or not to apply preventive measures”, the doctor adds.

At the moment, when the specialist is faced with cases of thrombosis, the specialist only suspects their risk of thrombosis. “In hospitals it is those who need surgical intervention (surgical patients) who are admitted to hospital and those who do not need it (medical patients)”, explains the expert.

A permanent electronic system

Although surgeons are more reliant on administering heparin, this occurs less frequently in medical patients”. This is serious because the medical patients admitted can suffer from cardiac insufficiency, acute infections or pulmonary de-compensation, factors that increase the danger of thrombosis, but in many cases the doctor is unaware of the thrombosis risk”, he points out. “Reminders are not enough, because people forget with the passage of time, but this alert system makes it a permanent reminder”, P??ramo insists.

By using this electronic system, the incidence of thrombosis has been reduced by 40% and the use of low weight molecular heparin has increased in between 30 and 60% of patients. For this reason P??ramo emphasises the need to make this more widespread in hospitals. “This tool is not a patent, for which reason each centre must adapt it to its own IT system with the idea of setting up the same protocol”, the researcher points out.

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