Medivation, Astellas begin prostate gland cancer drug analyse

Medivation and Astellas pharmaceutical company have proclaimed the discourse of first patient in a stage 2 study of MDV3100, a triple-acting oral exam androgen receptor antagonist, in the treatment of advanced prostate cancer patients who have shaped up while on LHRH analogue therapy or accompanying surgical castration.

The stage 2 study is configured to compare MDV3100 with bicalutamide - a typically used anti-androgen, and is expected to enroll approximately 370 patients in North America and European Union.

The basic endpoint of the trial is progression-free survival.

Astellas Pharma Global Development president Steven Ryder said this is the first of two Phase 2 trials in earlier stage disease i.e. being initiated to evaluate the potential benefit of MDV3100 in a broad spectrum of prostate cancer patients.

"The second of our new Phase 2 trials will analyse MDV3100 in an even earlier-stage population, and we expect to start the test in the first half of this year," Ryder said.

MDV3100 decelerates development and induces cell death in bicalutamide-resistant cancers via three complementary actions - blocks testosterone binding to the androgen receptor, impedes movement of the androgen receptor to the nucleus of prostate cancer cells (nuclear translocation) and inhibits binding to DNA.

IGCW- 2011: Industrial Green Chemistry World - 2011

IGCW- 2011: Industrial Green Chemistry World - 2011
Source : Industrisal Green Chem


Industrial Green Chemistry World is the platform to brings together the mainstream issues concerning Green Chemistry and Green Engineering to all stakeholders of Chemical Industry.

IGCW 2011 will provides, business leaders at all levels with insights into developing and enhancing profitable and sustainable means for implementing Green Chemistry and Green Engineering practices. Successful practitioners and experts in the field will present on the many current and future green and sustainable opportunities in the chemical industry.

Intoduction of IGCW 2011

The Industrial Green Chemistry World (IGCW) is a global platform for the Chemical Industry to explore, engage and exchange emerging trends and innovations implemented in the field of Industrial Green Chemistry and Engineering.

IGCW is an initiative by the Green ChemisTree Foundation, a philanthropic expression founded by Newreka Green Synth Technologies Pvt. Ltd for promoting, Green Chemistry and Green Engineering (GC&E) practices amongst diverse sections of societies, i.e.: Industry, Govt. bodies, Research Institutes, Academia, Students, etc.

The IGCW-2011 Symposium & Expo is primarily designed to bring forth GC&E initiatives by various chemical companies. It is an apt platform for Chemical companies to showcase their products & processes as adapted to GC&E principles, while providing an opportunity for many chemical companies to get inspired and see how at source changes are being incorporated for greening the processes.

Join, at the IGCW-2011 Symposium & Expo in Mumbai, India. Through your participation, be assured of an enriching exposure to diverse successful endeavors in the industry that can transform your thinking on your technological and business practices with world leading practices and global trends.


Contact:
Newreka Green Synth Techonologies Pvt.Ltd

405, Mastermind IV,
Royal Palms, Aarey Colony,
Goregaon ( East)
Mumbai – 400 065, India
T : +91-22-2879 1835.
    +91-22-2879 1275.
F : +91-22-2879 4790.
E : krishna.dave@newreka.co.in

XOMA 052 Disappoints - Pharma Research

Source: ZA QUOTE  - Xoma Drug Disappoints

Xoma Ltd. (XOMA) recently reported negative results, when trail is at mid-stage of type II diabetes treatment, XOMA  052. The stage IIb trial failed to meet the primary endpoint of reducing glycosylated hemoglobin (HbA1c) in type II  diabetes patients after six months of treatment with XOMA 052, compared to placebo. In the trial, patients were given one of the four XOMA 052 doses or placebo subcutaneously, once a month over a period of 6 months.

However, it was observed that biological activity of XOMA 052 significantly supported the candidate’s potential in cardiovascular diseases like a decline in C-reactive protein (CRP), a biomarker for the risk of heart attack, stroke and other cardiovascular diseases, versus placebo. Moreover, considerable improvement was observed in high-density lipoprotein (good cholesterol) in two of four XOMA 052 dosage strengths versus placebo.

Xoma Ltd....

Xoma has a collaboration agreement with Servier for the development and commercialization of XOMA 052 in the US. Per the terms of the agreement, Xoma retained the US and Japanese commercial rights to the candidate for Behcet's uveitis and other inflammatory and oncology indications. Further, Servier has worldwide rights to XOMA 052 for diabetes and cardiovascular disease indications. Servier also has rights for other indications in territories excluding the US and Japan.

Servier is to bear 100% of the first $50 million and 50% of additional development expenses for the Behcet's uveitis indication and will fully fund the development expenses for the cardiovascular disease and diabetes indications. Xoma is responsible for the manufacturing and launch of XOMA 052. As part of the deal, Xoma is eligible to receive milestone payments of up to $470 million and tiered royalties up to the mid-teens percentage rate.

For the Behcet's uveitis indication, the company has successfully completed a mid-stage trial, where all seven
patients displayed rapid reduction of intraocular inflammation and improvement in visual acuity or other ophthalmic measures after a single treatment with XOMA 052.

The drug has orphan drug status in the US and European Union for Behcet's uveitis and is scheduled to enter phase III clinical trials in 2011. The company also plans to move XOMA 052 into clinical development for cardiovascular disease in 2012.

Once XOMA 052 is approved, it will face competition from products of companies like Eli Lily and Co. (LLY), Novartis AG (NVS), AstraZeneca plc (AZN) and Regeneron Pharmaceuticals Inc. (REGN).

Novartis overtakes major stake of Chinese firm Zhejiang Tianyuan

Novartis has successfully finished its acquisition of 85% of Chinese vaccines firm Zhejiang Tianyuan Bio-Pharmaceutical. The deal of $125 million announced in the year 2009. Novartis Swiss based drugs giant says the acquisition will provide it with an expanded presence in the Chinese vaccines market and facilitate the introduction of additional Novartis vaccines into the country. The firms claim China represents the world’s third largest vaccines market, with annual industry sales of over $1 billion, and the expectation of double-digit growth over coming years. “This agreement combines the strength of our vaccines R&D strategy and pipeline with Tianyuan’s deep knowledge of the vaccines market in China,” remarks Andrin Oswald, head of Novartis vaccines and diagnostics.

Novartis.......

Novartis and Tianyuan will work jointly to expand the Chinese firm’s product portfolio and R&D pipeline through targeted investments in technology, manufacturing and commercial networks. “We have already identified several joint development programs that could be implemented in China over the next ten years, with the potential of launching key products responding to unmet medical needs in the mid-term”, claims Mr. Ding Xiaohang, founder, chairman and CEO of Tianyuan

FDA Grants 510(k) for "Life Technologies"

Source: GEN

Food and Drug Administration (FDA) has granted 510(k) clearance for Life Technologies’ StemPro® MSC SFM culture medium for the ex vivo tissue and cell culture of human mesenchymal stem cells (MSCs). Designed to culture MSCs in an undifferentiated state, StemPro MSC SFM was first introduced in May 2009 as a research-use-only product. Life claims the serum-free culture medium is the only product of its kind to have received FDA approval.

Clearance for clinical applications means there will be one less hurdle for the development of potential cell therapies based on MSCs, the firm maintains. “A key component for stem cell research to advance into clinical trials and beyond is the ability to put validated tools into the hands of researchers,” remarks Joydeep Goswami, head of primary and stem cells at Life. “The 510(k) clearance by FDA of our STemPro MSC SFM is a pivotal step in that direction.”

Life Technologies’ Cell Therapy Systems™ portfolio already comprises a range of 510(k)-cleared products for stem cell culture, isolation, expansion, differentiation, and characterization.
These include: AIM V® Medium, DMEM, KnockOut™ SR Medium, and KnockOut® SR XenoFree Medium.

Pharmassist – Pharmaceutical Contract Research Organisation, Athen, Greece

Pharmassist is a contract research organisation located in Athens, Greece, areas of services were regulatory affairs, pharmacovigilance, clinical trials, medical economics and biostatistics.

In a rapidly changing and demanding pharmaceutical market, our mission is to deliver timely, accurate, highly specialised and cost-effective services to our clients. Composed of integrally skilled and highly trained personnel, Pharmassist can guarantee high-quality services.

Pharmassist's range of services includes:

• Regulatory affairs
• Pharmacovigilance
• Clinical trials
• Pricing and market access strategy
• Medical information
• Scientific and medical training
• Support in business development
• Marketing and sales support
• Expanding country-specific services

Founded in 1999, Pharmassist has, over the years, established a network of experienced professionals and expert consultants in Greece and abroad. The breadth and depth of our experience has led to successful collaborations with multinational pharmaceutical enterprises and industries all over the world, reinforcing and confirming our excellent reputation within the healthcare arena and building the ground for new ventures.

Pharmassist is in the process of expanding the geographic coverage of the company to Balkan countries and Turkey as it is our aim to reflect the growing need for both multi-national and country-specific services within the healthcare arena.

Contact Pharmassist
Pharmassist Limited
262 Mesogion Avenue
155 62 Holargos
Athens
Greece
Tel: +30 210 65 60 700
Fax: +30 210 65 12 210
info@pharmassist.gr
www.pharmassist.gr

Fast, accurate (Automated MRI) test for Alzheimer's Disease

Fast, accurate (Automated MRI) test for Alzheimer's Disease 

Researchers at the National Institute for Health Research’s (NIHR) Biomedical Research Centre for Mental Health at the King's College London Institute of Psychiatry (IoP) and South London and Maudsley NHS Foundation Trust (SLaM) are the first to use an advanced computer programme to accurately detect the early signs of Alzheimer's disease from a routine clinical brain scan.  This advance Automated MRI scan can return 85 per cent accurate diagnostic results in under 24 hours. 

This 'Automated MRI' software automatically compares someone’s brain scan image against 1200 others, each showing varying stages of Alzheimer’s disease.  

Normally in routine clinical practice, brain scans are used to simply exclude diseases that can mimic Alzheimer’s disease, but here automated MRI software is being used for the first time in a NHS setting (Memory Clinics) to make an early and accurate diagnosis of the illness. 

Diagnosis in Starting Stage:

Early diagnosis of Alzheimer's is clinically difficult and patients with the early signs are frequently not treated until their symptoms become stronger. The new Automated MRI scan however can return 85 % accurate diagnostic results in under 24 hours.  

Starting stage diagnosis allows people to plan their care before the condition worsens - helping to prevent hospatalisation, dramatically improving their quality of life.  It is also a cost effective and efficient way to manage and organise treatment of the disease.

The Automated MRI scan programee has been developed by scientists at the IoP, together with colleagues from the Karolinska Hospital in Stockholm.

The Automated MRI computer programmee  is being 'tested' over the next 12 months with patients attending SLaM memory services in Croydon, Lambeth and Southwark.  The ‘field test’ will also provide a supply of research grade images, which has important implications for the development of the next generation of drugs for dementia and individualised treatments. 

There are 750,000 people with Alzheimer's diseases in the UK. The financial cost of dementia to the UK is over £20 billion a year. According to the Alzheimer’s Society, in just 15 years a million people will be living with dementia. This will soar to 1.7 million people by 2051.