The Demo Site

Dual-action cholesterol-lowering drug
The first single tablet that works by addressing both sources of cholesterol in the body – the liver and the diet – produced a 4.2% greater reduction in cholesterol levels as compared with patients on rosuvastatin therapy. The Phase IV study data, from patients with primary hypercholesterolaemia, was presented at the International Symposium on Atherosclerosis.
press release MSD/Schering-Plough, 18 June

Gastrointestinal disorders
AGI Therapeutics has released preliminary results from Phase II trials of two of their products. Arverapamil showed significant superiority over placebo in irritable bowel syndrome, but results for espindolol in functional dyspepsia were less conclusive. The company is waiting for the full trial results before deciding on the course of action for the latter.
press release, Financial Dynamics, 7 June

Monoclonal antibody success in B-CLL
Patients with progressive B-cell lymphocytic leukaemia have shown strong response rates to the monoclonal antibody treatment MabCampath (alemtuzumab) as a first-line therapy. The antibody targets the CD52 antigen, over-expressed in malignant lymphocytes. The overall response rate for MabCampath was 83%, compared with 56% on chlorambucil (standard chemotherapy).
press release, Leeds teaching hospitals, 6 June

New hope for cancer treatment
Reports at the annual meeting of ASCO were promising for Yondelis, originally isolated from a marine tunicate. A trial in patients with advanced myxoid liposarcomas reported 86% long-lasting objective remission and tumour control and another study, in ovarian cancer patients, announced 78% tumour control.
press release, Zeltia SA, 5 June

First approval recommendation for mozavaptan
The vasopressin V2-antagonist Physuline (mozavaptan) has been recommended for approval in Japan for the orphan indication of hyponatrarmia (low blood sodium) in malignancy-related syndrome of inappropriate antidiuretic hormone secretion.
provided by Scrip 10th May

New Phase II trial for treatment of nicotine addiction
More than 400 patients are to be enrolled into a trial of TA-NIC, Celtic Pharma’s vaccine for smoking cessation. The product is designed to bind nicotine in the blood, stopping it from crossing the blood-brain barrier and producing the pleasurable sensation of smoking.
provided by Scrip 10th May

Success in Phase I for Hep C therapy
OctoPlus, the Dutch drug delivery and development company, has announced the success of Phase I trials of Locteron, a controlled release formulation of alpha interferon for chronic hepatitis C patients. Results suggest Locteron could be dosed once every two weeks – compared with weekly dosing of current interferons – and that it has a good safety profile.
provided by press release 27th April

First EU biosimilars approval under new regulation
Omnitrope (somatropin) is the first product to have been granted marketing authorisation under the EU's new biosimilars regulation. Sandoz was granted approval of the product on 18 April and initial launches, in Germany and Austria, should take place in the new few days.
provided by Scrip, 20th April

Will new TB vaccine supplant the BCG?
Researchers are planning to trial a novel TB vaccine candidate, which may offer improvement on the BCG, the existing vaccine, in the next three years. SO2, developed at the Pasteur Institute in Paris and the University of Zaragoza in Spain, is based on a mutation in the PHOP gene in Mycobacterium tuberculosis.
provided by Scrip, 20th April

Roche files CERA despite disputes
Roche has filed CERA (continuous erythropoietin receptor activator) in the US to treat the anaemia of chronic kidney disease patients despite ongoing disputes with Amgen – owners of the competitor product, Epogen – who are undertaking both a patent suit and a complaint with the international trade commission over the product.
provided by Scrip, 20th April

Inhalable form of insulin to hit the market
The first inhalable form of insulin has been approved by the US FDA and the European Commission for the treatment of both Type I and Type II diabetes. Clinical trials of Exubera included more than 2,500 adults, each studied for an average duration of 20 months. The inhalant was found to be as effective as short-acting insulin injections and to significantly improve blood sugar control when added to diabetes pills.
Provided by Pfizer press release, 27 January, 2006

Inflammatory role in Alzheimer’s?
Researchers have reported in the Journal of Neuroscience that inhibiting the production of the pro-inflammatory cytokines released by activated glial cells showed promising results in pre-clinical models of Alzheimer’s disease. They suggest that these findings support the neuroinflammation hypothesis of Alzheimer’s progression, despite the fact that anti-inflammatories have shown little benefit in clinical studies of the disease to date.
Provided by Scrip, 24 January 2006

HIV/AIDS trial terminated early
One of the largest HIV/AIDS trials ever to be initiated has been called off before patient recruitment was complete. The announcement, from the National Institute of Allergy and Infectious Diseases, follows the finding that patients in the SMART trial, who were receiving episodic treatment with antiretrovirals (guided by their CD4+ cell levels), had more than double the risk of disease progression of those patients receiving continuous antiretroviral therapy (ART). Patients on episodic treatment also presented more of the complications associated with ART, which had triggered the hypothesis that a discontinuous protocol might have merit.
Provided by US NIH press release, 18 January 2006

First genetic risk factor for West Nile virus
While a lack of the cell surface protein CCR5 confers resistance to infection with HIV, it may result in an increased risk of contracting West Nile virus. The finding was published online in the Journal of Experimental Medicine, and it represents the ‘first genetic risk factor to be identified for West Nile virus’, says Elias A Zerhouni, Director of the US NIH. It may have cautionary implications for the treatment of HIV-positive individuals with experimental CCR5-blocking drugs say the researchers.
Provided by US NIH press release, 17 January 2006

Time in Phase II is well spent
Wyeth’s CEO, Robert Essner, outlined a new approach to clinical drug development at a Morgan Stanley conference in New York. The company will change its focus towards spending more time optimising the dose, patient and indication at Phase II rather than Phase III. He stated that he did not think this would necessarily reduce the cost of drug development, but that it would allow Wyeth to have a much higher probability of producing drugs in Phase II that are ‘really as optimal as they can be’,
Provided by Scrip, 9th January 2006

Vaccine against cervical cancer
Sanofi Pasteur MSD has announced it is submitting a marketing authorisation application for Gardasil to the EMEA. The product is a vaccine against the four most common types of human papillomavirus and it is hoped that it will offer protection against cervical cancer. Merck also submitted a biologics license application for Gardasil to the US FDA on 1 December and has announced plans to file for licensure in Australia, as well as other countries, in early 2006.
Press release from Sanofi Pasteur MSD, 12th December

UK clinical research reforms
The UK Chancellor of the Exchequer, Gordon Brown, has announced the next stage in the science and innovation investment framework 2004–2014. It sets out a series of measures with the aim of making the UK a world-class clinical research centre. Reforms include the establishment of a new National Institute for Health Research and a commitment to developing the NHS IT system to facilitate the recruitment of patients to clinical trials. The announcement prompted a statement from the Industry Reference Group of the UK Clinical Research Collaboration to the effect that their investment in R&D in the NHS would increased by up to an additional £1 billion per year in the medium- to long-term – approximately a 30% increase.
Department of Health, 2nd December

Human 'bird flu' vaccine
Trials are set to begin in China for a human vaccine against bird flu. The Chinese FDA has given the regulatory go-ahead for Sinovac Biotech's Phase I trial of a vaccine against the NIBRG-14 strain of influenza. China has just reported its third confirmed human death from avian flu - of a woman who had been in contact with infected poultry.
provided by Scrip, 28th November

Collaboration for HIV research
GlaxoSmithKline Biologicals has reached an agreement with the Pasteur Institute in France to work together to develop a vaccine against HIV. The Pasteur Institute's vaccine vector technology, based on the Schwarz strain of the measles virus, will be used to deliver the HIV proteins Gag, Pol and Nef. Two clinical studies are planned: to study the vaccine's safety and to test its immunogenicity in people who have a pre-existing immunity to measles. The research will be supported by an EU €5.5 million grant.
provided by Scrip, 28th November

Nasal vaccine against flu?
The Universal Vaccine project, lead by Arexis, has secured a euro 1.2 million EU grant to support the development of a nasal vaccine for lifelong protection from influenza. The grant comes as part of the EU 6th Framework Scientific Programme’s Co-operative Research Projects.
Provided by Scrip, 18th November

Potential challenge for Avastin
Results from the Phase II ACROBAT trial presented at the recent European Cancer Conference in Paris suggest that ImClone Systems’s Erbitux (cetuximab) could be used as a first-line therapy for metastatic colorectal cancer. If successful, this will place Erbitux in direct competition with Avastin (bevacizumab). The Phase III CRYSTAL trial, set to look into use of the medication as a first-line therapy, has completed enrolment and hopes to report results early next year.
Provided by Scrip, 18th November

Type II diabetes trial fails
The results of the largest interventional trial for diabetes type II to date, the FIELD study of Solvay’s fenofibrate, show that the drug failed to reach its primary endpoint of a reduction in coronary heart disease events. While the drug did produce a reduction in non-fatal myocardial infarction, experts say this will not be sufficient to support greater use of this product in diabetes.
Provided by Scrip, 18th November

US$35 million for nanotechnology in cancer
The US National Cancer Institute has announced US$35 million in awards for research into the potential of nanotechnology in cancer therapy. The awards will establish 12 Cancer Nanotechnology Platform Partnerships and include a mix of projects. They are designed to develop technologies in six key areas: molecular imaging and early detection, in vivo imaging, reporters of efficacy, multifunctional therapeutics, prevention and control and research enablers.
provided by NIH press release, 17 October

EU introduces ‘sunset clause’
Marketing authorisations will cease to be valid in the EU if the products concerned have not been marketed within three years of the authorisation being granted. MAs will also expire once a product has not been marketed for three years. The new rule will take effect from 20 November for centrally authorised products and by 30 October (at latest) for nationally authorised products.
provided by Scrip, 14 October

Schering and TAP Pharmaceuticals halt dosing in trial
Phase III trials of asoprisnil have been halted following concerns over adverse events. The drug, for use against uterine fibroids, is thought to have caused endometrial thickening in some women. The decision to halt the trial was not called for by the data safety and monitoring board, but was made independently by TAP Pharmaceuticals after discussions with the board, Schering said.
provided by Scrip, 14 October

Potential risk of stroke associated with Livial
The hormone replacement therapy, Livial (tibolone), could be associated with a possible increased risk of stroke in elderly patients with osteoporosis. The risk was highlighted in the British Medical Journal as the results from a preliminary safety evaluation of the LIFT study were published. The data safety and monitoring board has recommended that the trial continue however, as the risk assessment was based on small numbers and multiple analyses of many safety outcomes.
provided by Scrip, 14 October

Katrina: US NIH helps trial participants
Following hurricane Katrina, physicians caring for patients in US National Institutes of Health-sponsored clinical trials in the area are being told to ring a consultation line for advice. Medical experts at NIH, academic medical centres and national medical professionals’ societies will be on call 24 hours, seven days a week and trial participants can also phone for information. US National Institutes of Health director, Dr Elias Zerhouni, said: ‘Our goal is…to help patients in the affected area who were on clinical trials and receiving treatment.’
provided by NIH press release, posted 15 September

ACRP and APPI denounce premature disclosure of data
A joint statement of support for Senator Charles E Grassley’s investigation into the sale of confidential clinical trial information to financial analysts has been issued by the ACRP (Association of Clinical Research Professionals) and the APPI (Academy of Pharmaceutical Physicians and Investigators). ‘Individuals within the research profession who are proven to have engaged in this practice should be censored by the industry and prosecuted to the full extent of the law for their violations,’ says Dr Gary Shangold, president of the APPI.
provided by ACRP press release, 14 September

EU votes for six-month SPC extension
The European Parliament has voted for a six-month supplementary protection certificate (SPC) extension for paediatric medicines. A number of other amendments were also considered, including a minimum notification period that SPC extension will be sought of just six months before a patent is due to run out. This amendment was passed, a move that disappointed generic companies, but only by a slim majority. It could fall out if the draft regulation returns for a second reading.
provided by Scrip, posted 9 September

New arthritis drug wins out despite safety issues
In a unanimous vote, the US FDA's advisory committee has backed Bristol-Myers Squibb's Orencia (abatacept) for treating rheumatoid arthritis in patients unresponsive to methotrexate or anti-TNF agents. The main caveats were that it should not be taken with TNF blockers or given to pregnant women.
provided by Scrip, posted 9 September

Major trials show Arixtra's strength
A 20,000-patient OASIS-5/MICHELANGELO study has shown an efficacy-safety balance in favour of GlaxoSmithKline's Factor Xa inhibitor, Aritxtra, over Sanofi-Aventis's low molecular weight heparin, Lovenox/Clexane at day nine, day 30 and six months for patients with acute coronary syndromes. The results were presented at the European Society of Cardiology meeting in Stockholm.
provided by Scrip, 9 September

EMEA releases paediatric guideline
The European Medicines Agency has launched a six-month consultation period on its first draft guideline on pharmacovigilance in paediatric populations. The guideline discusses both adverse-event reporting and long-term drug safety studies. The first results from the Agency's paediatric expert group survey have also been released, which aims to find the gaps in paediatric medical care in Europe. The medicines available to children in the fields of pain and rheumatology have both been assessed.
provided by Scrip, 23 August

Congestive heart failure study disappoints
A Phase II trial of Cardiome Pharma's xanthine oxidase inhibitor, oxypurinol, has failed to produce positive results in patients with congestive heart failure. The lead investigator, Dr Josh Hare at the John Hopkins University School of Medicine, described the study as being one of the most rigorous Phase II trials in the cardiovascular arena.
provided by Scrip, 23 August

Cholesterol therapy causes concern
Australia's Adverse Drug Reactions Advisory Committee has called for doctors to be more vigilant in reporting cases of muscle disorders observed in patients taking Merck Sharp and Dohme's ezetimibe (Ezetrol), a cholesterol absorption inhibitor. The Committee has had 44 reports of such adverse events since the launch of the drug in June 2003.
provided by Scrip, 23 August

Increasing use of thalidomide in multiple myeloma patients - In response to public demand, Japan has given orphan drug status to thalidomide for use in patients with muliple myeloma. Fujimoto Pharmaceutical is to start clinical trials of the drug for this indication in patients who did not show a response to other therapies.
provided by Scrip, posted 23 August

Informed consent in emergency settings - In emergency medicine there may be insufficient time to obtain informed consent from patients to allow their participation in a clinical trial. The UK Department of Health has proposed that patients may be entered into such trials for a period of 24 hours without consent if absolutely necessary. The proposal is currently under consultation.
provided by Scrip, posted 5 August

Companies agree to voluntary guidelines over DTC ads
23 pharmaceutical companies, including Lilly, Johnson and Johnson, Pfizer and Aventis, have agreed to comply with guidelines set out by the US PhRMA regarding direct-to-consumer advertising. This includes the submission of advertising material to the FDA before publication. However some critics say this does not go far enough: earlier this month Senator Bill Frist called for a two-year ban on DTC advertising of drugs when they first hit the market.
provided by Scrip, posted 5 August

Cannabis-like drug in trials - A trial of the cannabis-like drug, Sativex, is set to include 600 patients in Catalonia, Spain. So far, the drug is only approved for use in multiple sclerosis in Canada; the patients in the Spanish trial have a variety of diseases, including cancer, AIDS and other neurological illnesses. The first results of the trial will be announced May/June 2006.
provided by Scrip online, posted 5 August