More than one in seven British adults surveyed (15%)1
admitted to bypassing the healthcare system to get hold of prescription only medicine
without a prescription, a practice which 78% of GPs surveyed say is putting people’s
health and potentially lives at risk3, as some of the medicines obtained in this way may
be counterfeit.

New research indicating the scale of the counterfeit medicine culture was released today
as part of a hard-hitting campaign to educate the public of the risks involved in
purchasing fake medicines from unregulated websites. The Get Real, Get A Prescription
public awareness campaign is being launched in a partnership between Pfizer, the
Medicines and Healthcare products Regulatory Agency (MHRA), the Royal
Pharmaceutical Society of Great Britain (RPSGB), The Patients Association and HEART
UK.

Without recognising the dangers associated with counterfeit medicine, UK adults are
putting too much trust in illicit websites that are potentially selling them. Research
suggests that the majority (60%) of adults agree that they’re more trusting of all
purchases they make online today compared to five years ago1. In addition, alarmingly
almost a fifth (18%) of UK adults believe people who sell prescription only medicine
without a prescription, are providing a service to the general public - offering cheaper
medicines to those that need it1. A third (33%) simply think what’s being sold is real
thing, sourced from legitimate places and sold on1.

David Pruce from the Royal Pharmaceutical Society of Great Britain said: “Pharmacists
are very concerned about the increase in fake or counterfeit medicines. As expert
professionals in medicines and medicines use, we know only too well that fake
medication does not work and that it can cause harm. Stay safe by ensuring that you
always get your prescriptions dispensed at a registered UK pharmacy. If you want to buy
medicines online, always check that you are dealing with a genuine pharmacy. Don’t go
on face value - some of the illegal sites look very professional but supply dangerous
fakes. Check our website for a list of sites that have been awarded the RPSGB’s internet
pharmacy logo so that you can be sure that you are dealing with a UK registered
pharmacy supplying genuine medicines. This campaign is important. We want the UK to
be the safest place to obtain medicines.”

Steve Poulton, Pfizer UK Commercial Director and Business Unit Head, said: “We are
thrilled to be partnering the Royal Pharmaceutical Society of Great Britain in this
deliberately hard-hitting campaign, aiming to push the counterfeit medicines issue up the
agenda and discourage consumers from by-passing the health system. Pharmacists
play a key role in delivering healthcare services and enhancing the patient experience,
something Pfizer supports through a range of activities such as this campaign.”
Pfizer, the RPSGB, and the other campaign partners have been working with
pharmacists across the UK to help them leverage public interest in this issue, as a
patient education opportunity.

A hard-hitting TV advertisement, which is considered so shocking that it can only be
shown after 11pm, will kick-off the campaign on Tuesday 3rd November. A national
billboard poster campaign will also run nationwide in November, with a consumer
roadshow touring seven cities over the next week. Consumers can go to
http://www.realdanger.co.uk for more information and advice.

Notes

– The Get Real, Get A Prescription campaign is supported by Pfizer, the MHRA, RPSGB (the
professional and regulatory body for pharmacy), The Patients Association and HEART UK.

– It is estimated that between 50 -90%4,5 of medicines now purchased over the internet are counterfeit,
with global sales in fake medicines expected to reach $75 billion by 20106. Here in the UK, two thirds of
GPs surveyed (67%) have seen patients who have obtained medicines from illicit sources3.

– Fake medicines can contain harmful ingredients such as rat poison, boric acid and lead paint7,8. They’re
often produced by people with no appropriate qualifications9 and can include too much, too little or none
of the active ingredient they should include6. Fake medicines can cause harm to patients, which can
sometimes lead to death6.

– If you have been offered what you suspect to be counterfeit medicines, or have seen them for sale, or
have bought them, we would like you to tell us. The Medicines and Healthcare products Regulatory
Agency (MHRA) is the medicines safety watchdog and has a dedicated 24 hour hotline: 020 7084
2701, E-mail: counterfeit@mhra.gsi.gov.uk or write to: Counterfeits, The Intelligence Unit, MHRA,
Market Towers, 1 Nine Elms Lane, London, SW8 5NQ.

– If you think a medicine or herbal medicine has caused an unwanted side effect (an adverse drug
reaction), please report the problem to the MHRA’s Yellow Card scheme http://yellowcard.mhra.gov.uk/.
The Yellow Card scheme has been used for over 40 years to collect information on suspected side
effects from all types of medicines. These include prescription medicines, medicines you can buy
without a prescription, and herbal and other complementary medicines.

– The RPSGB provides a list of legitimate, approved online pharmacies on its website for people to check
before they buy from an online source: http://www.rpsgb.org.uk

About the Royal Pharmaceutical Society of Great Britain

The Royal Pharmaceutical Society of Great Britain (RPSGB) is the professional body for pharmacists and
the regulatory body for pharmacists and pharmacy technicians in England, Scotland and Wales. The primary
objectives of the Society are to lead, regulate, develop and represent the profession of pharmacy.
The RPSGB leads and supports the development of the profession within the context of the public benefit.
This includes the advancement of science, practice, education and knowledge in pharmacy. In addition, it
promotes the profession’s policies and views to a range of external stakeholders in a number of different
forums.

Following the publication in 2007 of the Government White Paper Trust, Assurance and Safety - The
Regulation of Health Professionals in the 21st Century, the Society is working towards the demerger of its
regulatory and professional roles. This will see the establishment of a new General Pharmaceutical Council
and a new professional body for pharmacy in 2010.

About Pfizer

Pfizer Inc, founded in 1849, is dedicated to better health and greater access to healthcare for people and
their valued animals. Every day, colleagues in more than 150 countries work to discover, develop,
manufacture and deliver quality, clinically effective prescription medicines to patients.
In the UK, Pfizer has its European R&D headquarters at Sandwich and its UK business headquarters in
Surrey, and is the major supplier of medicines to the NHS. Pfizer invested over £5.4 billion worldwide (£104
million per week) in R&D in 2008.

About a healthy partnershipTM

a healthy partnership was launched by Pfizer in 2008 as a new approach to support the increasingly
important role of community pharmacy in the delivery of healthcare and new services being offered to
patients. It covers three areas highlighted as being important by pharmacists: Supporting professional
development, enhancing the patient experience and delivering commercial value.

References

1. YouGov Plc data, September 2009. Participants: 2076 adults.

2. 7.1 million calculated using Office National Statistics Census 2007. 15% of UK adults
aged 18 and over = 7,179,660

3. Medix UK plc (2009) Market Research Report: Counterfeit Drug Study. Participants: 205

4. WHO and IMPACT factsheet. Counterfeit drugs kill! Last accessed on 13.10.09 from
here.

5. In-PharmaTechnologist News. Last accessed 08.10.08 from here.

6. WHO factsheet. Counterfeit medicines. Last revised 14 November
2006 http://www.who.int/medicines/services/counterfeit/impact/ImpactF_S/en/ last
accessed 10 October 2009

7. Soloman, S. BC Woman killed by fake drugs bought online. National Review of Medicine,
2007. 4:13.

8. Pfizer data on file

9. European Alliance for Access to Safe Medicines. The Counterfeiting Superhighway, 2008
Medicom

Source
Royal Pharmaceutical Society of Great Britain

Short-term hormone therapy given prior to and during intermediate dose radiation treatment for men with early stage prostate cancer increases their chance of living longer, compared to those who receive the same radiation alone, according to a Radiation Therapy Oncology Group (RTOG) study, the largest randomized trial of its kind, presented November 2, 2009, at the American Society for Radiation Oncology (ASTRO) annual meeting. The RTOG trial noted that this benefit appeared to be greatest for men currently defined as at medium-risk for disease failure.

The phase III study is one of the largest clinical trials of prostate cancer therapy ever completed, with 2,000 low- and intermediate-risk patients enrolled in the trial from October 1994 to April 2001. This trial was conducted by the RTOG and followed men with early-stage prostate cancer in most cases for more than nine years. This time period is sufficient to show improved survival benefits of short-term hormone therapy added to what was then the standard radiation treatment for prostate cancer, which involved slightly lower doses of radiation than are currently used today with newer techniques, such as intensity modulated radiation therapy (IMRT).

“This landmark RTOG study provides strong scientific evidence that shows us when to deliver hormone therapy with radiation in men with localized prostate cancer. Prior to this trial, it was unclear whether or not combining hormone therapy with radiation for medium-risk prostate cancer patients would increase survival,” said Christopher U. Jones, M.D., an author of the study and a radiation oncologist at Radiological Associates of Sacramento in Sacramento, Calif. “It remains uncertain whether the addition of hormone therapy to the higher radiation dose and new technology treatments being employed today would provide the same or greater benefit to that documented in this study. It is possible that it could.”

According to Walter J. Curran, Jr., M.D., the RTOG Group Chair, and the Executive Director of the Emory Winship Cancer Institute and Associate Vice President for Cancer, Woodruff Health Sciences Center, “RTOG recently opened a new trial examining the role of hormone therapy combined with modern radiotherapy techniques for men with intermediate stage prostate cancer. When completed, the results of our new trial, RTOG 0815, will provide a complement to the results of our current landmark trial.”

Androgen deprivation therapy is hormone therapy used to treat prostate cancer by stopping or lowering the level of male hormones, or androgens, thereby removing the strongest growth factor for prostate cancer cells.

In the study, a total of 1,979 eligible men who had cancer confined to the prostate and a PSA less than or equal to 20 were randomized to receive total androgen deprivation therapy for two months prior to and two months during radiation treatment, or to receive only radiation therapy.

Findings show that short-term hormone therapy given to early-stage prostate cancer patients prior to and during radiation treatment significantly increases their chance of living longer (51 percent), compared to those who receive radiation alone (46 percent). Nearly all of the survival benefit was in the intermediate-risk group. Secondary endpoints of disease-free survival, freedom from biochemical failure, and positive two year re-biopsy rates were also better in the group who received short-term hormone therapy and radiation treatment.

The study was supported by grants from the National Cancer Institute.

The abstract, “Short-Term Endocrine Therapy Prior To and During Radiation Therapy Improves Overall Survival in Patients with T1b-T2b Adenocarcinoma of the Prostate and PSA ?20: Initial Results of RTOG 94-08,” was presented at the plenary session at 2:15 p.m. on Monday, November 2, 2009.

In addition to Dr. Jones, study authors include: DG McGowan, D. Hunt, Radiation Therapy Oncology Group, M Amin and H Sandler, Cedars-Sinai Medical Center, MH Leibenhaut, Sutter Health Cancer Center, SM Husain, Tom Baker Cancer Center, L Souhami, McGill University, and WU Shipley, Massachusetts General Hospital

Source: Shawn Farley

American Roentgen Ray Society

Men who receive a “boost” of proton therapy after receiving a standard course of X-ray radiation therapy have fewer recurrences of their prostate cancer compared to men who did not receive the extra dose of proton radiation, according to a first-of-its-kind study presented November 2, 2009, at the American Society for Radiation Oncology’s 51st Annual Meeting in Chicago. The multi-institutional, randomized trial also shows that the high dose treatment is safe for these patients and causes no severe problems later with urinary or bowel functions.

“There is a lot of interest in proton therapy for prostate cancer. This study proves the importance of giving high radiation doses to prostate cancer patients with low- and intermediate-risk disease because it demonstrates that even these ‘favorable’ patients still benefit from the extra high-dose treatment,” Carl J. Rossi Jr., M.D., a study author and a radiation oncologist at the Loma Linda University Medical Center in Loma Linda, Calif., said. “It also shows that so long as these higher doses are given with a highly conformal technique, such as proton beam therapy, then they can be delivered safely and with minimal side effects.

Proton beam therapy is a form of external beam radiation treatment that uses protons rather than photon X-rays to treat certain types of cancer and other diseases. The physical characteristics of the proton therapy beam allow the radiation oncologist to more effectively reduce the radiation dose to nearby healthy tissue.

During external beam radiation therapy, a beam of radiation is directed through the skin to the cancer and the immediate surrounding area in order to destroy the main tumor and any nearby cancer cells.
The study involved 391 patients with early prostate cancer (cancer that has not spread out of the prostate) receiving proton treatments at Loma Linda University Medical Center and Massachusetts General Hospital in Boston. Patients were randomized to receive either “standard dose” or “high dose” radiation, with proton beams being used to deliver the high-dose radiotherapy to prostate.

Findings show that in patients with a low risk of having the cancer return (recurrence), only six percent of patients who were treated with high dose radiation had the cancer return after 10 years, compared to 29 percent who had conventional radiation doses. Similarly, of the patients with an intermediate risk of cancer recurrence, 37 percent who underwent high dose radiation had cancer come back, versus 45 percent of those who had conventional doses of radiation. There were no significant differences between the two groups in how long they survived and in their urinary and bowel functions.

The abstract, “A Phase III Trial Employing Conformal Photons with Proton Boost In Early-stage Prostate Cancer: Conventional Dose (70.2gye) Compared To High Dose Irradiation (79.2 GyE): Long-term Updated Analysis of Proton Radiation Oncology Group (PROG)/American College Of Radiology (ACR) 95-09,” was presented at a scientific session at 11:20 p.m. on Monday, November 2, 2009.

Source: Beth Bukata

American Society for Radiation Oncology

Bristol-Myers Squibb Company (NYSE: BMY) and ZymoGenetics, Inc. (NASDAQ: ZGEN) today presented final results from a Phase 1b clinical trial of PEG-Interferon lambda administered with ribavirin in relapsed and treatment-naïve hepatitis C virus (HCV) patients. The poster included data on 56 patients in the study. Antiviral activity was observed at all dose levels tested. The results will be presented at the American Association for the Study of the Liver Diseases annual meeting in Boston on November 3. Interim results were previously presented at the European Association for the Study of the Liver annual meeting in April 2009.

“There is a strong need for additional options for hepatitis C patients,” said Brian Daniels, M.D., senior vice president, Global Development & Medical Affairs, Bristol-Myers Squibb. “We are pursuing this investigational pathway to address the fact that although current interferons have been the backbone of therapy with meaningful efficacy, they are often poorly tolerated, leading to dose reductions, poor compliance and avoidance of treatment.”

“We are excited about the prospects for PEG-Interferon lambda as a potential HCV treatment,” said Eleanor L. Ramos, M.D., senior vice president and chief medical officer of ZymoGenetics. “There is a clear unmet medical need for an interferon with improved safety and tolerability. We look forward to obtaining additional clinical data on this promising investigational medicine.”

The Phase 1b clinical trial was designed to evaluate the safety and antiviral activity of PEG-Interferon lambda when given as a single agent or in combination with ribavirin in genotype 1 HCV patients with relapsed disease and in treatment-naïve patients.

In the single agent arm of the study with treatment-relapsed patients (n=24), PEG-Interferon lambda was administered subcutaneously at 1.5 mcg/kg and 3.00mcg/kg weekly for four weeks, and 1.5 mcg/kg and 3.00 mcg/kg every two weeks. In the combination arm of the study with treatment-relapsed patients (n=24), PEG-Interferon lambda was administered subcutaneously weekly at 0.5 mcg/kg, 0.75 mcg/kg, 1.5 mcg/kg and 2.25 mcg/kg for four weeks, with daily oral ribavirin administered consistent with the package insert. Patients in the cohort of treatment-naïve patients (n=7) were given 1.5 mcg/kg of PEG-Interferon lambda and ribavirin.

PEG-Interferon lambda demonstrated antiviral activity at all dose levels tested in both relapse and treatment naïve HCV patients. A majority of patients across all treatment arms achieved a greater than 2 log reduction in HCV RNA.

Of the patients in the single agent arm of the study, all 12 of those patients receiving 1.5 mcg/kg and 3.0mcg/kg weekly for four weeks achieved a greater than 2 log decrease in HCV RNA. Five of the 12 patients receiving 1.5 mcg/kg and 3.00mcg/kg every two weeks for four weeks achieved a greater than 2 log decrease in HCV RNA.

At PEG-Interferon lambda doses of 0.75 mcg/kg, 1.5 mcg/kg and 2.25 mcg/kg administered in combination with ribavirin in treatment-relapsed patients (n=18), a greater than 3 log mean maximum decrease in viral load was observed. Of those patients, eleven (61%) had less than 1,000 HCV RNA copies at Day 29.

Treatment-naive patients, who were treated with 1.5 mcg/kg of PEG-Interferon lambda in combination with ribavirin (n=7), also had a greater than 3 log mean maximum decrease in viral load and two patients (29%) achieved a rapid virologic response (RVR), or undetectable HCV RNA copies, at 4 weeks.

The most common adverse events were fatigue (29%) and nausea (13%). There were minimal effects on neutrophil counts. Minimal constitutional symptoms or hematologic effects were observed with PEG-Interferon lambda given as a single agent or in combination with ribavirin. The majority of adverse events and laboratory changes were grade 1 or 2. Dose-limiting elevations in ALT or AST, with or without an increase in bilirubin, were dose-dependent and reversible.

Overall, the results of the study support moving to dose-ranging Phase 2 studies in treatment-naïve HCV patients.

About Interferon lambda

Interferon lambda (IL-29) is a type 3 interferon that binds to a unique receptor with more restricted distribution than the receptors targeted by type 1 interferons, such as interferon alpha. It is in development for hepatitis C. The native human protein Interferon lambda is generated by the immune system in response to viral infection. IL-29 is a member of the type 3 Interferon family, which includes IL-28A and IL-28B, and signals through the same receptor as IL-28A and IL-28B.

Source
Bristol-Myers Squibb
ZymoGenetics

A new study published in Nutrition Journal indicates that XanGo® Juice, a market-leading, premium mangosteen beverage, has lowered levels of C-reactive protein (CRP) in overweight and obese people in a randomized, double-blind, placebo-controlled human trial. CRP is a marker used to measure inflammation levels, and a reduction in CRP may indicate a corresponding reduction in the risk of heart disease and diabetes. This study also suggests that XanGo Juice has healthful properties for weight management.

Mike Pugh, a scientist at XanGo, explains, “The reason why the scientific community is interested in probing inflammation is that it may be an early indicator of heart attack, stroke and diabetes, potentially even lung disease, skin conditions and arthritis. So, scientists test CRP as a first step in assessing an individual’s level of inflammation, and then, in turn, they use that to help picture a patient’s potential for these serious diseases.” Current understanding of body fat suggests that reducing inflammation may also assist in managing one’s weight, which may have wellness benefits of its own.

XanGo’s chief marketing officer, Larry Macfarlane, elaborates on why XanGo whole-heartedly supported the research performed by Dr. Jay Udani at Medicus Research in California, “Sometimes, consumers turn to pharmaceutical products as a preventive measure to maintain good health. While consumers should always consult with their healthcare provider before changing their dietary regimen, XanGo realizes that our flagship product, XanGo Juice, might provide a natural alternative for maintaining good health.”

In the study, Dr. Udani tested three different dosages (varying between three to nine ounces) of XanGo Juice against a placebo juice. Participants consumed the assigned beverages twice a day, in the morning and evening. All three dosages of XanGo Juice demonstrated an ability to reduce CRP as a marker of inflammation. Dr. Udani comments, “Subjects who consumed the highest dose demonstrated a statistically significant reduction in CRP (1.33 mg/L). The other doses had non-significant reductions in CRP while the placebo group actually increased their CRP level.”

Body fat percentage was significantly different between the three-ounce juice group and placebo. This three-ounce group also experienced a significantly lower body mass index (BMI) score compared with placebo at eight weeks. The six-ounce group had significantly lower BMI than placebo at four weeks and at eight weeks.

Dr. Udani reports that no side effects or safety concerns emerged at any dosage tested, and cautions that longer studies with larger numbers of participants are needed to confirm the findings and further probe a possible dose-dependent effect. However, this first human clinical trial points to exciting avenues for XanGo Juice’s use in the maintenance of heart health and other conditions that may be connected to inflammation.

Previous research shows the xanthonesin XanGo Juice may possess antioxidant and anti-inflammatory properties that may help sustain a healthy cardiovascular system, support cartilage and joint function, support the immune system, promote a healthy seasonal respiratory system, maintain intestinal health and neutralize free radicals.*

Source: Drew Milam

Publicis Consultants | PR

A University of Adelaide study may have shed light on the rise in childhood asthma in developed countries like Australia in recent decades.

Researchers from the University’s Robinson Institute have identified a link between folic acid supplements taken in late pregnancy and allergic asthma in children aged between 3 and 5 years, suggesting that the timing of supplementation in pregnancy is important.

Associate Professor Michael Davies says that folic acid supplements recommended for pregnant women to prevent birth defects appear to have “additional and unexpected” consequences in recent studies in mice and infants.

“In our study, supplemental folic acid in late pregnancy was associated with an increased risk of asthma in children, but there was no evidence to suggest any adverse effects if supplements were taken in early pregnancy.”

The University of Adelaide findings have been published in the American Journal of Epidemiology.

The study involved more than 500 women whose maternal diet and supplements were assessed twice during their pregnancy, with follow-up on their child’s asthma status at 3.5 years and 5.5 years. Asthma was reported in 11.6% of children at 3.5 years and 11.8% of children at 5.5 years. Nearly a third of these children reported persistent asthma.

Current public health guidelines recommend that women consume a supplemental dose of 400 micrograms of folic acid per day in the month preceding and during the first trimester of pregnancy to reduce the risk of neural tube defects in children.

“Our study supports these guidelines, as we found no increased risk of asthma if folic acid supplements were taken in pre or early pregnancy,” Associate Professor Davies says. However, these guidelines may need to be expanded to include recommendations about avoiding use of high dose supplemental folic acid in late pregnancy.”

He says their study found no evidence to link asthma with dietary folate, which is found in green, leafy vegetables, certain fruits and nuts.

Nearly half of all mothers in the study took a folic acid supplement pre-pregnancy and 56% met the required daily dosage of 400 micrograms in early pregnancy.

“These findings show there is a potentially important critical period during which folic acid supplement dosages may be manipulated to optimise their neuro-protective effects while not increasing the risk of asthma,” Associate Professor Davies says.

Source: University of Adelaide

A pivotal efficacy trial of RTS,S, the world’s most clinically advanced malaria vaccine candidate, is now underway in seven African countries: Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania. The trial, which is expected to involve up to 16,000 children, is on schedule, with more than 5,000 children already enrolled, researchers announced Tuesday at the 5th Multilateral Initiative on Malaria Pan-African Malaria Conference.

Developing a vaccine against malaria, a scientific challenge for decades, is critical to defeating the disease. A vaccine would complement existing interventions, such as bed nets and effective drug therapies. GlaxoSmithKline Biologicals’ (GSK Bio) RTS,S is the first malaria vaccine candidate to demonstrate significant efficacy during early development to warrant Phase III testing. It is the leading vaccine candidate in the global effort by the PATH Malaria Vaccine Initiative (MVI) to develop a malaria vaccine.

“A malaria vaccine could help save countless lives and redefine the future for Africa’s children,” said Dr. Patricia Njuguna, RTS,S principal investigator (KEMRI-Wellcome Trust, Kilifi, Kenya) and chair of the Clinical Trials Partnership Committee, a collaboration of African research institutions, MVI, and GSK Bio that is leading the clinical development of RTS,S. “Communities all across Africa are dedicated to this future and are participating to ensure that we develop a vaccine with an acceptable safety and efficacy profile.”

RTS,S is the first vaccine designed primarily for use in Africa, where malaria kills more than 800,000 people every year, the majority of them children under the age of five. By conducting the trial in seven different countries across Sub-Saharan Africa, researchers will be able to evaluate the vaccine candidate’s efficacy in a variety of settings, with diverse patterns of malaria transmission. For example, some trial sites are located in areas where there is a year-round threat of malaria, while others experience only seasonal transmission.

All of the research centers were chosen for their track record of world-class clinical research, strong community relations and commitment to meeting the highest international ethical, medical, clinical and regulatory standards.

“This is a tremendous moment in the fight against malaria and the culmination of more than two decades of research, including 10 years of clinical trials in Africa,” said Dr. Joe Cohen, co-inventor of RTS,S and Vice President of R&D, Vaccines for Emerging Diseases and HIV, at GSK

Biologicals. “The Phase III trial is a huge undertaking that depends on effective coordination between researchers, regulators, families and communities. Everyone involved has invested significant energy and resources to pave the way for what could become the world’s first malaria vaccine.”

Recent Phase II studies showed that RTS,S reduced clinical episodes of malaria by 53 percent over an eight-month follow-up period. Findings from a Phase II trial initiated in 2002 and conducted with more than 2,000 children in southern Mozambique, published in the medical journal The Lancet in 2004 and 2005, showed that RTS,S was efficacious for at least 18 months in reducing clinical malaria by 35 percent, and severe malaria by 49 percent. , In addition, RTS,S was shown to have a promising safety and tolerability profile when used alongside the World Health Organization’s (WHO) standard infant vaccines.

“This historic trial could lead to the availability of a vaccine with the potential to save the lives of hundreds of thousands of African children, if the data are positive,” said Dr. Christian Loucq, director of the PATH Malaria Vaccine Initiative. “But development is only half the mission; MVI and its partners are committed to ensuring this vaccine reaches those who need it most. We hope the international community will respond by starting to prepare for the day when - if all goes well - this vaccine will be available for distribution and use.”

The Phase III trial

The Phase III trial will evaluate the vaccine’s efficacy in two groups of children. One group, aged 6 to 12 weeks, will be vaccinated as part of their regular schedule of infant immunizations; the second group includes children aged 5 to 17 months. The vaccine profile is intended primarily for infants, as they and children under the age of five are the most vulnerable to malaria.

“This is the largest trial ever conducted in Africa of a vaccine specifically designed for use with African children. We have great appreciation for the families and children participating,” said Dr. Salim Abdulla, director of the Ifakara Health Institute, Tanzania, which is participating in the Phase III trial. “Development of RTS,S across Africa has strengthened our research capacity, a legacy that will far outlast the trials.”

Each country hosting a study site has undertaken independent reviews to ensure the trial meets national safety, ethical and legal standards for medical research. In addition, an independent data and safety monitoring board oversees the entire trial with support from local safety monitors. The trial has been designed in consultation with appropriate regulatory authorities in the European Union, the United States and African countries, in conjunction with the WHO.

Looking ahead

If the Phase III program progresses as expected, RTS,S could be submitted for regulatory review under Article 58 as early as 2012. Article 58 is a special review procedure that allows the European Medicines Agency (EMEA), in close collaboration with the WHO, to issue a scientific opinion regarding the quality, the efficacy and the safety of a medical product that is intended for use exclusively outside the European Union.

Under current plans, the RTS,S vaccine candidate would be submitted to regulatory authorities in 2012 based on efficacy in children 5-17 months of age. Additional safety and immunogenicity data from the infant population will be submitted soon thereafter, followed by efficacy data for infants once available. Depending on the final clinical profile of the vaccine and the timetable of the regulatory review process, the first vaccine introduction could take place over the next three to five years.

“GSK’s approach is to make every effort possible to accelerate the availability of this life-saving vaccine,” said Mr. Jean Stephenne, President and General Manager, GlaxoSmithKline Biologicals. “Ever conscious of the burden of malaria, we have no time to lose and we will exhaust every avenue at our disposal. This is our commitment as a company.”

MVI, the WHO and US Agency for International Development developed the Malaria Vaccine Decision-Making Framework to help countries prepare to make decisions related to future adoption of a malaria vaccine and thereby avoid unnecessary delay between the recommendation for use of a vaccine and its availability in low-income countries. GSK and MVI are already working with malaria-affected countries and international institutions to ensure that, if successful, a malaria vaccine will be readily available and affordable to those who need it most.

Source: Preeti Singh

PATH Malaria Vaccine Initiative

Katie Moore

GSK Biologicals

BioAlliance Pharma SA (Paris:BIO), a company dedicated to the treatment and supportive care of AIDS patients, has presented results on miconazole Lauriad® at the 47th Annual Meeting of the Infectious Diseases Society of America (IDSA) in Philadelphia (October 29 - November 1st).

The additional results from BioAlliance Pharma’s pivotal Phase III study with miconazole Lauriad® mucoadhesive buccal tablets (MBT) demonstrated comparable efficacy and safety profile to that of clotrimazole troches (administered five times per day) for oropharyngeal candidiasis (OPC), in HIV-positive patients in 40 sites in the United States, Canada and South Africa. The data also demonstrated a good patient compliance as a result of the added convenience of a once-a-day dosing.

This presentation was given by Dr Rajesh V. Lalla, oral medicine specialist, from the University of Connecticut Health Center.

OPC, also known as thrush, is an oral fungal infection most common in individuals with weakened immune systems - particularly those with HIV/AIDS and those undergoing cancer treatments. OPC is a disruptive condition that results in lesions and inflammation in the mouth, and includes symptoms such as soreness, burning and/or altered taste.

About IDSA

The Infectious Diseases Society of America (IDSA) represents physicians, scientists and other health care professionals who specialize in infectious diseases. IDSA’s purpose is to improve the health of individuals, communities, and society by promoting excellence in patient care, education, research, public health, and prevention relating to infectious diseases.

Source
BioAlliance Pharma

Affymax, Inc. (Nasdaq:AFFY) and Takeda Pharmaceutical Global Research & Development Center, Inc., announced data from a Phase 2 clinical trial of Hematide™ showing that Hematide increased hemoglobin and reduced or eliminated the need for blood transfusion in most patients with erythropoietin-induced pure red cell aplasia (PRCA). The data were published in the 5th November 2009 issue of the New England Journal of Medicine.

In the open-label, non-randomized trial, patients with chronic kidney disease (CKD), who had anti-erythropoietin antibody-mediated PRCA and who were anemic, generally experienced increases in hemoglobin above 11 g/dL following once monthly injections of Hematide.

PRCA is a rare, serious and debilitating autoimmune disorder, which can occur when the body produces neutralizing antibodies against the currently marketed recombinant human erythropoietins, such as epoetin alfa or beta and darbepoetin alfa, thus suppressing the production of red blood cells by the bone marrow. While PRCA is a rare disorder, it remains a concern among physicians and patients as it can significantly limit treatment options for anemia in patients with CKD and requires these patients to receive regular blood transfusions. Hematide is under development for the treatment of anemia associated with chronic renal failure, including patients on chronic dialysis and not on dialysis. Hematide is a novel investigational synthetic, PEGylated peptide-based erythropoietin (EPO) receptor agonist with no sequence homology with human EPO, and hence is not expected to induce PRCA.

“These data suggest that Hematide may be a promising anemia treatment alternative for patients in this population, with a different immunogenicity profile than other erythropoiesis-stimulating agents,” said Iain C. Macdougall, M.D., consultant nephrologist in the Department of Renal Medicine at King’s College Hospital in London, Hematide clinical investigator and lead author of the New England Journal of Medicine article. “Hematide stimulated red blood cell production in most patients with antibody-mediated PRCA and thereby diminished these patients’ dependence on blood transfusions. Additionally, following the start of treatment with Hematide, most patients experienced a decline in their levels of neutralizing anti-EPO antibodies associated with the underlying PRCA condition.”

The purpose of this study was to test whether Hematide given subcutaneously can stimulate red blood cell production in patients with anti-EPO antibodies, who otherwise had a compromised ability to generate red blood cells. Fourteen patients were treated with Hematide for a median of 28 months (range 3-36). Thirteen of the 14 patients (93%) achieved the primary endpoint of an increase in hemoglobin to a level greater than 11 g/dL without the need for regular blood transfusions.

While the number of patients tested is small, the beneficial effect was consistent and sustained for up to 156 weeks. Further, in six of 14 patients, titers of anti-erythropoietin antibodies fell below the detection limit following treatment with Hematide.

Overall, adverse events were generally mild or moderate in severity. Adverse events that were possibly related to Hematide were hypertension, bone pain and injection site hematoma. Two serious adverse events were considered possibly related to Hematide (severe anemia and lack of response) and both occurred in a patient who developed anti-Hematide antibodies. This patient initially responded to Hematide, but later had a diminished clinical response despite increasing doses of the drug.

“We are encouraged by these findings, which suggest fundamental differences with Hematide compared to commercially available ESAs,” said Anne-Marie Duliege, M.D., M.S., chief medical officer of Affymax. “If approved, we believe that Hematide could represent a significant new treatment option for providers caring for patients with chronic renal failure.”

About Hematide

Hematide is a synthetic, peptidic erythropoiesis stimulating agent (ESA) linked to polyethylene glycol (PEG) that is being developed for the treatment of anemia associated with chronic renal failure.

Affymax and Takeda are collaborating on the development of Hematide and plan to co-commercialize the product once approved in the United States. Phase 3 clinical trials are being conducted to investigate the potential for Hematide to treat anemia associated with chronic renal failure.

About PRCA

Dialysis and non-dialysis patients with CKD frequently develop anemia because of a reduction in native EPO production by dysfunctional kidneys. Since the late 1980s, recombinant EPO has been used successfully to treat anemia-associated EPO deficiency. A small number of CKD patients develop antibody-mediated PRCA, a type of anemia that develops when patients mount a neutralizing antibody response against recombinant EPO used to treat the anemia associated with CKD. These antibodies neutralize not only the recombinant EPO but also cross-neutralize natural EPO produced by the patients, leading to a state of EPO resistance and transfusion dependence. While the incidence of PRCA is low, there continues to be sporadic reports of antibody-mediated PRCA associated with commercially available EPO products. Concern over PRCA prompted the addition of warnings in the prescribing information of all EPO-based products marketed in the U.S. In April 2009, currently marketed ESA manufacturers warned healthcare professionals of the potential for antibody-mediated PRCA when the drugs are used to treat anemia associated with interferon or Pegylated interferon and ribavirin therapy in patients with HCV infection.

About Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral insomnia, rheumatology and gastroenterology treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.tpna.com.

Source
Affymax, Inc.

WASHINGTON — The FDA and online retailer Bodybuilding.com have announced a recall of all lots of 65 dietary supplements believed to contain steroids.

Specifically, the agency and company said the supplements could contain steroid ingredients identifed as superdrol, madol, tren, androstenedione, and/or turinabol.

Most of the recalled items are taken for body mass and muscle building, and some have names that reference the ingredients responsible for the products’ recall. A full list of recalled lots is available on the FDA Web site.

The retailer issued a statement saying it has received no claims of adverse effects from customers and was assured by manufacturers that the products were properly classified as dietary supplements and contained no unlawful ingredients.

Side effects of steroids include:

• acute liver damage
• shrinkage of testes
• male infertility
• masculinization of women
• male breast enlargement
• short stature in children
• predilection for abuse of other drugs
• adverse effects on blood lipid levels
• increased risk of heart attack, stroke, and death

The FDA recommends patients using the recalled products immediately stop use and contact a physician if any of the adverse steroid-related effects occur.

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