Bioven, a biotechnology company that focuses on developing therapeutic cancer vaccines, is aiming to raise US$16 million to fund its clinical trials and fast-track the commercialization of its three breakthrough therapeutic cancer vaccine products: EGF, TGF and HER-1, and the nasal spray, hepatitis B therapeutic vaccine.
The company has secured ownership and rights to market the Cuban technology globally for US$32 million.
The founder and chairman of Bioven, Mukhriz Mahathir, announced: “We are looking for investors to come into the project.” He said that the funds raised will be used for Phase II and III clinical trials for its EGF cancer vaccine and hepatitis B vaccine in Asian and European sites.
The company is currently in the midst of a Phase II/III clinical trial programme for the breakthrough cancer vaccine products, the most developed of which is the EGF cancer vaccine on a total of 230 stage IIIb/IV non-small-cell lung cancer (NSCLC) patients.
The vaccine targets the EGF pathway, which promotes tumor cell proliferation and survival upon binding to its receptor, by developing a specific active immunotherapy based on EGF deprivation. The EGF vaccine can be used on 60% of all cancers, such as lung, breast, bladder, colorectal, head and neck, ovarian, p-ancreatic and prostate cancers.
The head of the project and Cancer Vaccines Research Officer, Gisela Gonzalez Marinello, notes that the EGF vaccine is not prophylactic, but fights the regeneration of carcinogenic cells. It is injected once a month as a complement to traditional treatments, such as chemotherapy and radiotherapy.
Previous trials for the vaccines conducted in Canada, Cuba and the UK have demonstrated that the product is safe and is able to stop the growth of lung cancer in terminally ill patients, extending life expectancy by up to 2 years compared with 6 months using existing treatments, according to Gonzalez Marinello.
She said that Cuba has already started the EGF cancer vaccine Phase III clinical trials on the cancer vaccine in terminally ill, late-stage NSCLC patients. The company aims to register the product in Cuba for use on patients by mid-2008.
Hospitals in Malaysia have already started to recruit patients who have late-stage cancer. Bioven aims to recruit up to 230 patients to conduct clinical trials. To reach these goals and to ensure approval in their new European territories, Bioven has identified trial sites in Europe, including London, UK.
“The outcome of this clinical trial will have global implications by bringing new hope to cancer patients. The clinical trials in Malaysia and Europe are designed to demonstrate the cancer vaccine’s ability to extend the lives of cancer patients and fast-tracking global approval for the products,” said Mukhriz.
Source: EGF cancer vaccine: Bioven’s first patented compound. www.bioven.com.my/bioven.html.
First published SF-6D utility measures for paraplegia and tetraplegia
An Australian study published in Value in Health provides the baseline utility values for people with a spinal cord injury compared with the general population, as well as measures of the changes in utility with changes in health status. The paper presents evidence that supports the use of the short form (SF)-6D health status questionnaire.
“The SF-6D utility measure can be calculated from the SF-36, a commonly available health-status measure used to assess the impact of disease and disability,” commented Bonsan Bonne Lee, lead author of the study. “We determined that the content of the SF-6D was actually more useful in populations, like people with a spinal cord injury who have significant physical impairment, than the underlying scale from which we calculated it (SF-36). We also found that the SF-6D can discriminate between different levels of disability and is responsive to clinically important changes in disability levels, which are key properties for usefulness in both population health and evaluation research.”
The cost of care and equipment for a person with a high-level spinal cord injury is estimated as AUS$50,000–280,000 per annum, dependent on level of injury. Utility values, which take into account people’s health preferences, can help aid governments and other health funders to work out the value of these healthcare expenditures to society.
Source: Lee BB, King MT, Simpson JM et al. Validity, responsiveness, and minimal important difference for the SF-6D health utility scale in a spinal cord injured population. Value Health (2008) (Epub ahead of print).
Impact of hepatitis B on quality of life
A study due to be published in Value in Health will provide valuable information for comparing new treatment options for chronic hepatitis B (CHB) by estimating preference-based utility weights for six increasingly severe health states that occur with chronic infection with the virus. Information was elicited from respondents living in six jurisdictions, in the USA, Europe and Asia, which ranged from low to high prevalence of CHB infection.
More than 350 million people worldwide are affected by the CHB virus, with infection causing considerable distress to individuals and costs of treatment resulting in substantial global economic loss. CHB is a condition that results in substantial morbidity and mortality worldwide because of progressive liver damage.
The impact of CHB on the quality of life of patients has not been well studied, and despite the availability of new treatment options, little information is available on how infected and uninfected persons value the impact of health states arising from the CHB virus.
Investigators undertaking economic evaluations of new therapeutic agents require estimates of health-related quality of life. Recent evidence suggests that differences in cultural backgrounds have a quantifiable impact on perceptions of health.
The authors interviewed 534 CHB-infected patients and 600 uninfected respondents, making this one of the largest valuations of health states ever published, for any disease. The results show that CHB and compensated cirrhosis health states have a moderate impact on health-related quality of life, and also indicated that there is a large detrimental effect on quality of life associated with decompensated cirrhosis and hepatocellular carcinoma.
Significant geographic differences were observed among countries, with a greater impact on quality of life seen in Hong Kong and mainland China, which are jurisdictions with a high prevalence of disease. The authors speculate that findings may be due to greater fear of the social consequences of infection. A practical implication of the intercountry differences is that economic evaluations may benefit from country-specific utility estimates.
Source: Levy AR, Kowdley KV, Iloeje U et al. The impact of chronic hepatitis B on quality of life: a multinational study of utilities from infected and uninfected persons. Value Health (2008) (Epub ahead of print).
Fast Track designation granted for CDX-110 for the treatment of glioblastoma multiforme
Drug: CDX-110
Tradename: NA
Manufacturer: Celldex Therapeutics, Inc.
Indication: Treatment of EGFRvIII-expressing glioblastoma multiforme
The US FDA has recently granted Celldex Therapeutics, Inc. (NJ, USA) fast track designation for their CDX-110 investigational immunotherapy for the treatment of EGFRvIII-expressing glioblastoma multiforme (GBM).
EGFRvIII, which is only found in cancerous tissue, is present in approximately 40% of GBM patients. CDX-110 immunotherapy works by activating a patient’s immune system against EGFRvIII, therefore selectively attacking the tumor cells. Recent trials of the immunotherapy have shown highly promising results.
In the ACTIVATE Phase II study, patients with EGFRvIII-expressing GBM who were treated with CDX-110 had a median survival of 30 months, compared with only 14.5 months in historical controls. The median time to progression was also longer, at 13 months (p = 0.0001) in CDX-110-treated patients compared with only 6.4 months in historical controls. In addition, in patients whose GBM recurred following treatment, the tumors had lost EGFRvIII expression.
In ACT II, an extension study, a similar patient population was treated with a combination of CDX-110 and chemotherapy. Although the study has not yet reached its median time to progression, preliminary progression-free survival and overall survival rates look similar to those found in the ACTIVATE trial, and as such are highly promising.
Finally, in September 2007, the first patient was randomized to the ACT III Phase II/III study of CDX-110 in combination with radiation therapy and temzolomide in newly diagnosed GBM. This study has been designed to investigate the safety, anticancer activity and impact on survival of adding DCX-110 to the standard of care for GBM patients in comparison to the standard of care alone.
“Fast Track status acknowledges CDX-110’s potential to fill an unmet need for glioblastoma patients and gives it priority within the FDA,” commented Thomas Davis, Chief Medical Officer of Celldex Therapeutics. “Confirmation of the promising results we’ve already observed is a high priority at Celldex, as it is within the brain cancer community in general.”
Source: AVANT & Celldex www.celldextherapeutics.com
Does the over-the-counter pill plan reduce teenage pregnancy?
The UK has the highest teenage birth rate in western Europe, with over 7462 girls under 16 years of age and 39,683 girls under 18 years becoming pregnant in 2005. Although there has been a decline in figures over the past few years, progress has stalled and the government is well away from meeting its target of halving the 1998 rate by 2010.
Under the new proposals, high-street chemists will be able to dispense oral contraceptives for free after one interview with a qualified pharmacist, where any health risks will be assessed. Similar to doctors, pharmacists will be able to give the pill to girls aged under 16 years without their parents’ consent if they believe that they are at risk of becoming pregnant. If the pilot proves a success, the pill will be available at chemists nationwide.
The Royal Society of Medicine said that it was delighted with the news, which it believed would help to address the high rate of teenage pregnancy.
Baroness Finlay of Llandaff, president of the Royal Society, has been campaigning for the move. “We have this catastrophic tidal wave of teenage and unwanted pregnancies – we are the worst in Europe, we cannot ignore that,” she said.
However, plans to allow women and girls under the age of 16 to obtain the contraceptive pill without a prescription have come under heavy criticism. Trevor Stammers, a general practitioner and a trustee of education charity, Family and Youth Concern, said that even greater access to contraception, which is already freely available, was not the answer to the sexual health crisis. He added: “Because the Government refuses to contemplate sex education aimed at delaying young people’s sexual debut, they have to put all their effort into increasing availability of contraception, but it will not work. They have increased availability of the morning-after pill and it has made no difference at all in the number of unwanted pregnancies.”
Anne Weyman, head of the Family Planning Association, said that the initiatives were “extremely welcome”, but that it would not make up for the lack of availability of more expensive, long-lasting methods of contraception, such as the new intrauterine devices, that some doctors fail to offer to keep down costs. “It’s absolutely essential that this initiative is part of a comprehensive and holistic approach to broaden women’s access to all 14 methods of contraception and not just the pill,” she said.
China’s new medical reform plan: will it be a ‘Healthy China’ by 2020?
China’s health minister has announced a new medical reform plan, which aims to give every person in China access to basic healthcare by the year 2020, increasing government responsibility and input. Called the ‘Healthy China 2020’ plan, the Chinese government’s goal is to have universal healthcare and equal access to public services for its 1.3 billion people.
A basic medicare network will be set up for the whole population by 2010 to reduce the widening gap of medical services among different income groups and regions. China’s Health Ministry has announced a plan to reform the health system and provide a national service for all citizens, including the rural population.
China’s current health system is under attack from many quarters for failing to provide basic healthcare. Reform of the medical health service began in 1992. Previously, the government covered at least 90% of medical expenses. However, the current system has been criticized as a profit-driven method of management.
In a report on the reform of medical care and the public health system delivered to the 31st session of the Standing Committee of the National People’s Congress, China’s top legislature, Chen Zhu said: “Government should play a leading role in providing medical care and public health services.” He acknowledged the “imbalanced” allocation of medical resources, which were concentrated in major urban hospitals. While attending to both the needs of medical institutions and patients, additional funds will be mainly used to provide medicare in rural areas and urban communities to reduce medical costs borne by patients.
“The aim is to provide safe, effective, convenient and low-cost public health and basic medicare service to both rural and urban citizens,” Chen said.
A health official from Guangdong who has been involved in some preplanning discussions said parts of the plan had already been trialed and failed, but were still included. He said that increasing government involvement and responsibility excited him, but that it would require careful planning and coordination to work properly.
Positive effect of etanercept on Alzheimer’s disease symptoms
A recent case report has documented extremely rapid improvements in cognitive abilities in an Alzheimer’s disease (AD) sufferer following spinal injection of the arthritis drug, etanercept (trade name Enbrel®).
Etanercept is a TNF-α receptor fusion protein that binds to TNF-α and neutralizes it. Elevated levels of TNF-α are hypo-thesized to be involved in the pathogenesis of AD. Therefore, researchers investigated the effect of treatment with etanercept on AD symptoms. The study reports the administration of etanercept into the spine of an 81-year old man with early stage AD. Prior to injection, a variety of cognitive tests were carried out on the man, who used to be a doctor. Within 10 min following the injection, the man could remember a variety of facts that he had previously been unable to recall, including the year, day of the week and the state in which he lived. He was also much calmer, more attentive and less frustrated following the injection.
Lead author of the study, Edward Tobinick, of the University of California and Director of the Institute for Neurological Research, said the drug had “a very rapid effect that’s never been reported in a human being before”. He added, “It makes practical changes that are significant and perceptible, making a difference to his daily living.”
Sue Griffin, editor the Journal of Neuro-inflammation and a researcher at the University of Arkansas for Medical Sciences (AR, USA), who wrote an accompanying commentary, said “It is unprecedented to see cognitive and behavioral improvement in a patient with established dementia within minutes of therapeutic intervention. This gives all of us in AD research a tremendous new clue about new avenues of research.” She added, “Even though this report predominantly discusses a single patient it is of significant scientific interest because of the potential insight it may give into the processes involved in the brain dysfunction of AD.”
While therapy to ameliorate disease symptoms and slow disease progression is available, there is currently no cure for AD. The memory loss, confusion and mood swings associated with AD make it a particularly distressing disease for those diagnosed, as well as family members and carers, to cope with.
Other experts in the field are also excited about the potential of this novel treatment, although they do stress that a great deal more research is required. Rebecca Wood, of the Alzheimer’s Research Trust (Cambridge, UK) commented, “This is promising and innovative research but in the early stages and further work is needed before we can conclude etanercept could work as a treatment for AD. We need to investigate whether it is safe and works in a larger number of patients as well as monitor the long-term effects. Scientists also need to check the benefits weren’t just due to the placebo effect and establish whether any benefit is just temporary or whether the disease itself is slowed.”
Sources: Tobinick EL, Gross H. Rapid cognitive improvement in Alzheimer’s disease following perispinal etanercept administration. J. Neuroinflammation 5(1), 2 (2008)
Griffin WS. Perispinal etanercept: potential as an Alzheimer therapeutic. J. Neuroinflammation 5(1), 3 (2008).
Generic drug production begins in Uganda
Continuing a positive record in the fight against HIV/AIDS, a Ugandan factory will shortly begin production of triple therapy antiretroviral medication (-Triomune: lamivudine, stavudine and nevirapine), as well as first-line malaria treatment (Lumartem).
The first drug order will be produced by Quality Chemical Industries (Uganda) and Cipla (India). The cost of a month’s supply of antiretroviral drugs will be approximately 30% less from the plant compared with imported medication, at approximately US$9 per month. The money to cover the initial batch of drugs will come from the Ugandan Health Ministry and other government agencies, as well as donor organizations. The Ugandan government is reported to have included a HIV/AIDS category in its budget for funding generic drug production and other HIV/AIDS services.
Initially, the plant will produce drugs for government distribution only, expanding to private sector and export to other African countries (e.g., Rwanda and Tanzania) in the future. It is hoped that the addition of home-produced generic medication will assist Uganda and surrounding nations to reduce the prevalence, incidence and human cost of HIV/AIDS.
Source: www.kaisernetwork.org
Overprescription of proton pump inhibitors draining NHS funds
Proton pump inhibitors (PPIs) are one of the most frequently prescribed classes of drug worldwide because they combine a high level of efficacy with low toxicity. In 2006 alone, expenditure on these drugs was £425 million in England and £7 billion globally.
Yet studies consistently show that PPIs are being overprescribed worldwide in both primary and secondary care. Between 25 and 70% of patients taking these drugs have no indication for the prescription, claim authors Ian Forgacs and Aathavan Loganayagam from King’s College London, UK.
PPIs have been a tremendous therapeutic advance and have proved valuable in patients with previously intractable symptoms of gastroesophageal reflux, with its associated complications, and patients at risk of iatrogenic upper gastrointestinal pathology.
The first generic PPI (omeprazole) was introduced in 2002 and now comprises more than four-fifths of all prescriptions for PPIs in the UK. Although effective and less expensive alternative drugs, such as H2 receptor antagonists, are available, prescriptions for PPIs have superseded those for all other acid-inhibiting agents and now account for over 90% of the NHS drug budget for treating dyspepsia.
Authors Ian Forgacs and Aathavan Loganayagam say that these relatively expensive drugs are being prescribed too eagerly, accusing hospital doctors of prescribing PPIs too readily and GPs of failing to take patients off the drugs once they are no longer indicated.
“Effective and cheaper alternative drugs are available for many patients. Yet prescriptions for PPIs have superseded those for all other acid-inhibiting agents and now account for over 90% of the NHS drug budget for treating dyspepsia,” they told the British Medical Journal.
“Although they are incredibly safe and effective for indigestion, PPIs are being overused. It’s a bit like giving morphine for a headache.”
In 2000, the National Institute for Health and Clinical Excellence (NICE) issued its PPI guidance, stating that the NHS could save up to £50 million a year in drug costs in England and Wales by prudent prescribing of these drugs.
Since then, the price of omeprazole, which makes up 90% of NHS dyspepsia prescriptions, has decreased because its patent has expired, and thus other companies can make generic versions of the branded drug for sale at a fraction of the price.
Richard Stevens, chairman of the Primary Care Society for Gastroenterology, said this might now mean it was cost effective to prescribe the drugs more frequently. However, he cautioned: “We do not want patients taking these drugs unnecessarily. Not all patients require acid suppression.”
Although PPIs are safe drugs, they are not without side effects. An increase in the prevalence of pneumonia and Campylobacter enteritis is reported, as well as a doubling of the risk of infection with Clostridium difficile. Acute interstitial nephritis and osteoporosis have also been reported, but such effects are fortunately rare.
A NICE spokeswoman said: “It is always disappointing when our recommendations are not consistently followed. For many patients PPIs should only be used for a short period of time until the underlying cause of the dyspepsia can be identified and treated. We would strongly urge Primary Care Trusts to use the criteria set by NICE for prescribing PPIs so that they can be confident they are targeting resources where they are most likely to offer benefit.”
Source: Forgacs I, Loganayagam A. Overprescribing proton pump inhibitors. Br. Med. J. 336(7634), 2 (2008).