Newron and Merck Serono’s Safinamide misses goal in pivotal Parkinson's phase III study
Milan/Geneva – Italian drugmaker Newron Pharmaceuticals and its partner Merck Serono have failed to demonstrate that its investigational drug Safinamide provides a significant benefit as a treatment for advanced Parkinson’s disease as an add-on therapy to levodopa. In a three-arm phase III extension study, neither a 50 mg nor a 100 m mg once daily dose of the drug achieved the primary efficacy study endpoint of improving dyskinesia after 24 months of treatment. However, safety was confirmed in the study involving 544 patients. Dyskinesia, which consists of involuntary and twisting movements of the face and body, is a major complication of levodopa therapy, resulting in a significant deterioration of patient quality of life. At baseline, 32% of patients showed troublesome dyskinesia. The companies’ goal is to file a MAA for their alpha-aminoamide MAO-B blocker as an add-on therapy for dopamine agonist therapy in patients with early Parkinson's disease, and as an add-on for levodopa therapy in patients with advanced Parkinson's.
Rome/Milan – Together with two Italian research institutes, British drug giant GlaxoSmithKline has begun to develop a therapy for the heriditary immune defect ADA-SCID, which affects only 350 children worldwide. Fondazione...
Rome/Milan – Together with two Italian research institutes, British drug giant GlaxoSmithKline has begun to develop a therapy for the heriditary immune defect ADA-SCID, which affects only 350 children worldwide. Fondazione Telethon and Fondazione San Raffaele have succeeded with a gene therapy in Phase I and IIa aimed at fixing the stem cells in the patient’s own bone marrow. The partners want to apply the same technique in trials for other rare diseases such as metachromatic leukodystrophy or Wiskott-Aldrich syndrome. The cooperation is part of GSK’s strategy to position itself in the orphan drug market.
Rome – When it comes to GMOs, the gap between Italy’s federal government and its regions that has marked the country for years is rapidly widening into a gulf. The latest rupture was on display at the October session of the...
Rome – When it comes to GMOs, the gap between Italy’s federal government and its regions that has marked the country for years is rapidly widening into a gulf. The latest rupture was on display at the October session of the Conferenze Stato Regioni ed Unificata. The body’s 22 members represent the regions and autonomous provinces of Italy, and the conference is where the provinces struggle to be heard at the national level. On October 7th, the message was clear. The regional chiefs called on Italian Minister for Agriculture Giancarlo Garlan to impose a full moratorium on the two GMO varieties licensed for cultivation in Italy and the EU – Monsanto’s MON810 and BASF’s amflora potato. The provinces have rejected Garlan’s proposed guidelines for coexistence. After an Italian farmer in Friuli-Venezia Giulia broke a de facto national moratorium on biotech crops that has been in effect since 1998, Garlan instructed the country’s national research body (CRA – Centro Ricerche Agricoltura) to carry out additional tests in order to feed into work on establishing coexistence guidelines. With the regions almost unilaterally opposing coexistence – only Lombardy cast no vote – Garlan said he is now trying to think of an alternative way to “ensure the progress of science and the liberty of research.”
Valletta – A new Life Sciences Park is to be created on the outskirts of Malta’s capital Valletta. The EUR20m project will provide space for companies operating in biotechnology and medical sciences. The park will be located in...
Valletta – A new Life Sciences Park is to be created on the outskirts of Malta’s capital Valletta. The EUR20m project will provide space for companies operating in biotechnology and medical sciences. The park will be located in the immediate vicinity of the Mater Dei Hospital and the University of Malta to foster close ties between start-ups and the two academic entities. Facilities at the park will include labs, offices and conference rooms over an area of 10,000m2, while a further 3,500m2 will be used for incubation facilities. “We are working on the infrastructure that will enable the country to move towards a knowledge-based economy,” said Alan Camilleri, the executive chairman of Malta Enterprise, which is involved in the project.
Verona – Scientists at GlaxoSmithKline in Verona have discovered that specific neurons in the amygdala control how mice react to fear stimuli. When they switched off the so-called Type I cells in the animals’ amygdala, the mice...
Verona – Scientists at GlaxoSmithKline in Verona have discovered that specific neurons in the amygdala control how mice react to fear stimuli. When they switched off the so-called Type I cells in the animals’ amygdala, the mice no longer froze when confronted with a fear stimulus, but took flight instead. Through functional brain imaging, the team headed by Angelo Bifone discovered that the switch from passive to active fear responses was controlled by the interaction of Type I cells with cholinergic neurons in the cortex.
San Michele all’Adige – The genetic code of the Golden Delicious apple has been deciphered. Led by Riccardo Velasco at the Edmund Mach Foundation in San Michele all’Adige in Italy’s Trentino province, a team of scientists from 20...
San Michele all’Adige – The genetic code of the Golden Delicious apple has been deciphered. Led by Riccardo Velasco at the Edmund Mach Foundation in San Michele all’Adige in Italy’s Trentino province, a team of scientists from 20 institutions all over the world took two years to unravel the apple’s DNA. It’s the largest plant genome decoded to date (Nature Genetics, 29 August 2010). The apple and its close relative, the pear, both have 17 chromosomes. That’s about twice the number of chromosomes in other plants from the same family. Sequencing the tree’s genome revealed that long stretches of certain chromosomes are copied in others, and many of the duplicate genes in apple trees are related to fruit development. The apple DNA study suggests that a major step in the evolution of the apple coincided with a catastrophic event some 60 million years ago, and may have been a survival response during a period of mass extinctions. Velaso said that sequencing the genome “would have huge implications for applied breeding.” He thinks the data will soon be used by experts to “help us to develop high quality traits and bring new products to the apple market.” At the moment, there are around 7,500 recognised varieties of apple.
Rome/Sydney – A novel therapy based on Yttrium-90-loaded beads has been shown to be safe and effective in patients with inoperable colorectal cancer liver metastases (British Journal of Cancer 103: 324-331) in a phase II trial...
Rome/Sydney – A novel therapy based on Yttrium-90-loaded beads has been shown to be safe and effective in patients with inoperable colorectal cancer liver metastases (British Journal of Cancer 103: 324-331) in a phase II trial with 52 patients. As the study group, headed by Prof. Maurizio Cosimelli at the National Cancer Institute Regina Elena in Rome, demonstrated that liver tumours in one patient (2%) disappeared and that 11 patients (22%) showed a partial response – their tumours shrank by at least 30%. Additionally, a further 12 patients (24%) showed stabilisation of their disease. Liver tumours shrank in two patients (4%) far enough to make a potentially curative surgery can. The overall median survival was 12.6 months for all patients participating in the experiment. The cancer experts recorded a significantly longer survival in 24 patients (48%) responding to the SIR-spheres (Sirtex Medical Pty. Sydney) or where the disease was stabilized in comparison to patients as non-responsive (median 16 months versus 8 months, P = 0.0006). Furthermore, 40% of those who responded were still alive two years after treatment, compared to none of those subjects who did not respond. Light to moderate side effects, especially fever and pain appeared in 16% of patients in the first 48 hours and at 22% between the third and 30 Days reported. The study was conducted as a single-arm study, as this group of patients had no other treatment options. Each year 145 000 Americans and 307,000 Europeans are diagnosed with colorectal cancer. About half of these patients develop metastases, mainly in the liver. Up to 90% of them die from liver failure. Selective Internal Radiation Therapy (SIRT) with the use of yttrium-90 resin beads loaded is a new approach for treating liver metastases. The microspheres are implanted by interventional radiologists to selectively targeted tumours with radiation, while the vital healthy liver tissue is spared and preserved.
: It’s hard to be a pro-GMO campaigner in Italy. Since 2001, the regions there have not implemented the plans for coexistence that were suggested by a ministerial decree. Instead, there was a de facto Italian moratorium on GM...
Silvano dalla Libera is a maize farmer who runs a farm in Vivaro in the Friuli region of northern Italy. In 2004, dalla Libera co-founded Futuragra, a cultural organisation that promotes the use of innovative technologies in farming in general and biotechnology in particular. In June, he met EU representatives in Brussels in an attempt to lobby against the nationalisation of GMO-cultivation guidelines that have been announced by EU Health and Consumer Policy Commissioner John Dalli. Euro|BioTech|News Signor Dalla Libera, in June you went to Brussels with a Futuragra delegation to protest John Dalli’s plans for the nationalisation of GMO cultivation...
dalla libera: We met with representatives from different EU bodies, among them the President of the Committee for Agriculture and Rural Development of the European Parliament, Paolo de Castro, and representatives from the cabinet of Manuel Barroso. For all of them, we had the same message: the Dalli proposal is a proposal against a unified Europe, because it will create different conditions all over Europe.
Euro|BioTech|News How come?
dalla libera: It will not only lead to disadvantages for many farmers in relation to their European colleagues, but also make Europe vulnerable to agricultural GMO-imports from countries outside the EU. In a recession like this, we need more Europe – not less. We feel the Commission should be consistent. If it creates new economic differences, it should be ready to compensate farmers for loss of income. We want to establish an observing body to evaluate the damage done to the Italian economy by the ban on GMOs. At the moment, some estimates place the damages at about a1bn – or more – over the last 10 years.
Euro|BioTech|News What else are you doing at the national level?
dalla libera: We believe in courts, not in Italian politicians. We have appealed the decree issued by Luca Zaia. So we are once again asking the Consiglio di Stato to lift the ministerial ban. We expect a decision in July. At the European level, we have appealed to the European Commission, because we argue that Italy is infringing on European laws with its reluctance to implement the coexistence rules. But former Environmental Commissioner Stavros Dimas blocked everything. John Dalli recently sent an answer saying he will look into it again. Back at the national level, Giancarlo Galan appears to be more positive regarding GMOs than Zaia, who was fundamentally opposing them. Galan recently gave some hints that experimental research on GMOs could be revitalised. Now he has to deliver, and approve working guidelines for open-space experiments.
Euro|BioTech|News But does Italy have the scientific backbone to conduct leading research?
dalla libera: Up to 2001, there were about 250 open-space experiments with genetically engineered plants underway in Italy. Italy was one of the first three countries worldwide to start these experiments. None of these led to problems with contamination or security. At the moment, just one or two projects are still running, and they will be concluded soon. This is a disgrace for a developed country. Euro|BioTech|News Local Italian media reported that a farmer illegally planted some GM maize near Pordenone. Do you know anything about that? dalla libera: We are not in any way involved in the Pordenone planting. I think it is an act of desperation. I understand it, but I don’t approve of it. We’ve chosen to go through the courts.
Euro|BioTech|News But if Dalli has his way, the Italian government might soon be able to impose a ban legally. Then the courts won’t help anymore.
dalla libera: That’s right. But as I said, we don’t believe in politicians, but in farmers and consumers. In the long run, they will decide. According to a survey in March of 2009, 53% of the farmers in the Veneto and Friuli districts said they would like to plant GM maize. 35% of consumers are also already willing to buy it, and this percentage will rise when public communication about GMOs is based on scientific facts, and not on campaigns about “Frankenstein food”. We need a common agricultural policy in Europe that includes GMOs as a means of production.
Euro|BioTech|News Futuragra is an Italian organisation. How do you want to have an European impact?
dalla libera: Europe needs a strong lobby of farmers arguing for balanced communication about GMOs. One of our main goals in the near future is to establish European contacts. We already have ties to Spanish and Romanian agricultural groups. The next step would be the establishment of a European umbrella group of GMO advocates modeled after Futuragra. Euro|BioTech|News What’s your motivation when arguing in favour of GMOs?
dalla libera: GM crops are good for the environment.They are healthier, and they provide an economic opportunity. But another issue is even more important. Freedom is the main force behind both the economy and society – especially in Italy. Business productivity was the reason for the Italian boom after the war. Now everything is blocked by excessive bureaucracy. I want to break that blockade.DContact: email@example.com
Milan – One of Italy’s biggest biotech players wants to raise EUR58m to boost its pipeline of cancer therapies. The round will be closed on July 16th. With operating costs of EUR22.5m and a total loss of about EUR17m in 2009,...
Milan – One of Italy’s biggest biotech players wants to raise EUR58m to boost its pipeline of cancer therapies. The round will be closed on July 16th. With operating costs of EUR22.5m and a total loss of about EUR17m in 2009, MolMed needs the money to continue operations. Good results from several drugs in Phase II have improved confidence in the biopharmaceuticals maker. TK, a cell therapy aimed at boosting survival of leukaemia patients undergoing stem cell transplantation, has entered Phase III testing. Several varieties of NGR-hTNF – a recombinant therapeutic protein that is a combination of a tumour homing peptide (NGR) with the human Tumour Necrosis Factor (hTNF) – have also completed Phase IIa tests.
Milan – Italian researchers have restored sight to blind patients using stem cells from the patients’ own bodies. In a study published by the New England Journal of Medicine (10.1056/NEJMoa0905955), scientists from Modena and...
Milan – Italian researchers have restored sight to blind patients using stem cells from the patients’ own bodies. In a study published by the New England Journal of Medicine (10.1056/NEJMoa0905955), scientists from Modena and Milan treated 106 patients whose eyes had been severely damaged by chemical burns. The researchers derived the stem cells from the respective patient’s own eyes, specifically from around the limbus, the rim around the cornea where stem cells are naturally produced by the body to repair it. The cells were then induced to multiply. Once they had enough stem cells, the researchers removed the scar tissue on the blinded eyes and grafted the stem cells onto the cornea. The graft then began to regenerate new corneal tissue. After 12 to 24 months, the grafts were followed up by corrective surgeries. All in all, the treatment had a 77% success rate – and some of the recoveries were quite remarkable. One patient had burned both his eyes severely with alkali back in 1948. The researchers were able to adapt and derive limbal stem-cell cultures with biopsied tissue taken from the patient’s left eye. The therapy successfully restored both corneal surfaces, returning normal, combined vision (around 20/30) to a patient who had been blind for over 60 years.
Rome/Maryland – The Vatican has taken a bold step into unchartered territory with its decision to finance new research into the potential use of adult stem cells for the treatment of intestinal disease and possibly other...
Rome/Maryland – The Vatican has taken a bold step into unchartered territory with its decision to finance new research into the potential use of adult stem cells for the treatment of intestinal disease and possibly other conditions. According to an announcement issued by the University of Maryland, the Catholic Church has agreed to donate US$2.7m to the International Intestinal Stem Cell Consortium, which brings together researchers from the Center for Stem Cell Biology and Regenerative Medicine at the University of Maryland, the University of Salerno, the Bambino Gesù Childrens’ Hospital in Rome and the Istituto Superiore di Sanita – Italy’s leading public health institution. “This research protects life,” said Cardinal Renato Martino, a former head of the Pontifical Council for Justice and Peace, during a meeting with Italian and American scientists and health officials. The Vatican is strongly opposed to embryonic stem cell research, but encourages the search for alternatives. The investment received blessings from the very top of the Catholic hierarchy. In 2007, Pope Benedict XVI said that adult stem cell research is acceptable because it respects “the life of the human being at every stage of his or her existence.” The project is still at a preliminary phase, Vatican officials said.
7th Berlin Conference on IP in Life Sciences: Big Data, Big Drugs
The health care industry faces significant transformation, driven by a boom in knowledge within biomedical sciences and breakthrough technologies such as gene sequencing. The management of "big data“ will change the understanding of diseases, development of drugs and treatment of patients. more