Services

Contact

Address:
Gaea | Clinical Ltd
One Broadcarr Road
Macclesfield
SK11 0AQ
United Kingdom

Gaea Clinical Trial Services LLC
97343, Saint-Petersburg,
ul. Matrosa Zheleznyaka, 57A, 122N

Tel: +44 1625 413 900
Fax: +44 1452 798 222
Mobile: +49 151 51 11 19 31
Email: ngg@gaea.co.uk

News

2015 / 2014 / 2013 / 2012



24th November 2016:

Gaea works with Flex Databases

Flex Databases CTMS provides Gaea with a real-time online overview of all studies and activities. Partnering with Flex Databases is an important step in the digitalisation of Gaea. Implementation of the CTMS reduces time and efforts for keeping the overview of operational data on different levels. The system provides digital dashboard for all team members and supports the efficiency across operations. The Flex e-System reduces paper work and allows a more environmentally -friendly document management which has been a priority of Gaea Clinical. Flex Databases is a software solutions company that provides instant access to CTMS, LMS and EDC. Unlike traditional e-Systems developers, Flex Databases provides a combination of extraordinary flexibility, fair prices, go-the-extra-mile service and support with a constant focus on quality.


Flex Databases











21th June 2015:

Award of a phase III trial in intensive care

Gaea has been awarded a full service 50 European site phase III trial in an intensive care setting with a 30% mortality rate with standard of care. I am delighted to be again working in ICU after my prior work in shock.




30th December 2014:

End of 2014 Report from Eseriani Wild Life, EWA, Kenya - supported by Gaea |Clinical

Kenyans with Kenyans for Kenyan wildlife preservation

Eseriani stands in the Maa language for "Peace". The aim of EWA is to help prevent human wildlife conflicts (HWC) and so help to conserve Kenyan wildlife, by working closely with communities and wildlife authorities to mediate and mitigate any form of such conflict. HWC arises from the push of humans into wild life areas with domestic life stock so forcing herbivores away and leaving lions and leopards with domestic wild stock as prey. In addition, the competition for the scare resource of water forces elephants into conflict. In all cases unless local communities see there is value in wildlife the wildlife will lose. The Government is supposed to compensate but with all in Africa the result is almost non-existent. So EWA creates awareness of the value of living wildlife and education in managing life stock by local Kenyans to their own local communities.

"Today, Eseriani Wildlife Association (please see our Facebook page) received the monthly donation of Euro 500 from Gaea | Clinical. On behalf of EWA I would like to extent my sincere gratitude to our donor Nigel Goodman for his tireless and continuous support of our cause. Without this kind donation, EWA will not be able to respond to the daily cases that happen as a result of human-wildlife conflicts (HWC). Once again I would like to send an appeal for donations, I always do this hoping that more donors will join in and put Eseriani on the map. Many of our followers know what we had been doing, anytime a conflict occurs Eseriani is needed to come in and contain any form of tension from the community that leads to the desire to make revenge attacks on wild life, and we work side by side with the Kenya Wildlife Service. To sustain our work, to make an impact, we need each and every little donation, our banking detail both local and foreign are on top of this group's wall. We will utilise in reducing HWC in the southern frontier. Soon we will revisit Torosei Elephants as the community has been calling us to go visit this area and promote tolerance. As many of you know, lions and leopards from Nairobi National Park (NNP) have been straying out of the park into the many homesteads dotting the unfenced southward side of NNP. To avoid losing this endangered predators we had been working towards many solutions one of them being compensation programme by our main donor Nigel G. Goodman, predator deterrent lights and education. Anyone else is so welcome to chip in any way; either donates fence or even transport to these areas as we keep doing our best to protect this precious wildlife."

Donation to PayPal email: eserianiwa@yahoo.com
Or
gofund.me/kenyanelephants

Contacts Email: eserianiwildlife@gmail.com or ngg@gaea.co.uk

Ibrahim Kantet EWA



11th December 2014:

End of 2014...

Each end of year, Gaea produces a card describing what we support from our work as a bespoke CRO and patient recruitment consultancy with our services at www.gaea.co.uk

Gaea focuses what we call our "social enterprise" efforts in the UK with the office on a budding nature reserve, and in Kenya where we have 3 children in school and 1 lady in university, and just meeting these needs is the tip of an enormous iceberg there and we do want we can for conservation.

We know it's been a difficult year for humanity, but the year has been even tougher for wildlife: Ivory from a single elephant's tusk can be worth more than $30,000. The elephant is killed for ivory to be sold to become chopsticks or to sit on a desk as a mark of human success.

Africa is losing at least 40,000 of this iconic keystone species a year, from a population of down to ~420,000. Its not just numbers the senior female and the big breeding bulls are being killed and so the family units and gene pools are being destroyed.

Elephants are not only dying from poaching, trophy hunting that is still legal in much of Africa so that the kleptocratic African politicians can profit, and from human - wild life interaction over scarce water and "slash and burn" farming in areas that belonged to wild life, and where the elephant and carnivores will always lose.

In August 2014, we reached a crucial tipping point, with more African elephants being killed each year than being born: that means extinction unless we stop this.

Many people are trying and they need our support, as if we "leave it to someone else" its over and the species is gone.

As an example of how Gaea tries to mitigate the human- wildlife issue please see our campaign: gofund.me/Kenya elephants

We feature Craig on the cover and we need to keep him alive as he deserves to live and his contribution to nature is significant - there would be few wild grown acacia trees without the seeds that elephants spread in dung and scrub would take over open land -- and for his genes. Alive he brings tourism, as we all want to see a magnificent bull (I look in the mirror each morning but its not happening) - and tourism brings money and jobs.

This "Silly Season" if you don't know what to give as a gift please give a year of foster parent for a baby orphan elephant, via the Sheldrick Wildlife Trust: www.sheldrickwildlifetrust.org


Gaea is a long- term supporter of Sheldrick.

Bull Craig













Bull "Craig" in Kenya


Milk dependent baby with her Sheldrick keeper in the Nairobi Orphanage: fully milk dependent babies drink 9 litres of Formula Milk a day and they can count - at least up to 3 per feed so no short measures! The Sheldrick Trust use 100-tons of Formula a year, which is donated by Pfizer UK defined as not fit for human consumption, and flown free by British Airways.

The babies leave Nairobi still taking some milk to move to one of 3 sanctuaries to live in and out of the wild under the care of keepers - to learn from older orphans and from interactions with the wild elephants - until they move to join a wild herd in 8-10 years: a huge commitment.

To foster a baby is $30 / $50 a year, and not only does Sheldrick rear the babies they also support a Flying Vet service, and this is how one of the largest surviving bulls in Kenya "Tim" recovered from a recent attempt to kill him.

Tim









Sheldrick vet with Tim after he was hit with a poisoned spear - sedated with a sedative dart













Tim post treatment (picture courtesy of Sheldrick Wildlife): he lives!

If $50 is too much, please consider donating to Eseriani Wildlife Association (EWA) with pay pal at eserianiwa@yahoo.com and every donation is welcome. Gaea support keeps the EWA afloat each month and we would value your help in their efforts to bring human wild life conflict to a positive result, to spare the wildlife and assist and educate the population that wild life is more value alive than as meat.

A Gaea message for 2015: "The reasonable person adapts to the world; the unreasonable one persists in trying to adapt the world. Therefore progress depends on the unreasonable person."



Gaea | Clinical

Europe - Russian Federation - USA

Office telephone: + 44 1625 413900

Director, Nigel Goodman Mobile: + 49 151 51 11 1931

www.gaea.co.uk



31st July 2014:

Enzalutamide in Metastatic Prostate Cancer before Chemotherapy

T.M. Beer and Others | N Engl J Med 2014;371:424-433 Published Online June 1, 2014

The PREVAIL study is now published. Enzalutamide significantly decreased the risk of radiographic progression and death and delayed the initiation of chemotherapy in men with mCRPC. Gaea is delighted to have been engaged in this trial, to ensure imaging on time and quality for the r-PFS primary endpoint.

http://www.nejm.org/doi/full/10.1056/NEJMoa1405095?query=TOC#t=abstract

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22nd July 2014:

Nordic Life Science Days, Stockholm, 2014

http://www.nlsdays.com

Nigel Goodman will be presenting at the meeting on 08th September 2014 on the topic of whether large CROs are the best fit for the needs of small sponsors.

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24th June 2014:

Gaea announces Recruitment Role in European Phase II Ovarian Cancer Trial

Gaea has been contracted to provide initial patient recruitment services in a large phase II trial in ovarian cancer.

Nigel Goodman, Director of Gaea, discussed this new project: "We are pleased to be involved in another project in ovarian cancer (OC) with a novel antibody, in addition to our current work as CRO on a phase I/II study in advanced OC. Unlike companies that offer yet more web solutions, the Gaea national recruitment specialist meets the site staff and defines the real issues that are blocking the site, and we offer practical solutions to the sponsor. We like to be involved before a study "flat-lines" on recruitment, as resuscitation is harder than earlier intervention. Gaea has a 10-year track record in moving patient recruitment forward, and we will work hard and fast to achieve results with this project. "

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19th May 2014:

Gaea announces a new phase I CRO project in GBM

Gaea is delighted to announce a new project for a phase I trial in Spain using an exciting oncolytic virus in glioblastoma. Our Senior CRA in Spain with over 12 years experience in clinical research will handle all clinical trial monitoring for the study; Gaea will take responsibility for Clinical Project Management.

"We are thrilled to be able to continue our work in oncolytic viruses, which have a huge potential in oncology; we pride ourselves on our prior work using such therapies and look forward to using our experience to help to make this trial a success", said Nigel Goodman - Director of Gaea. " GBM is also a very interesting field for me personally, having previously worked in this field when we struggled to get drugs across the blood-brain-barrier - to see a new drug with the incredible potential that it has in this area is certainly very positive".

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16th May 2014:

Are you attending the 50th meeting of ASCO?

Gaea will be at ASCO 2014 in Chicago, US, from Wednesday 28th May to Wednesday 4th June 2014.

We would be delighted to set-up a brief meeting with you to discuss our services as full service CRO, rescue CRO or fixing issues at trial sites in Europe, Russia and now also the USA. We have a track record in rescuing trials that are behind in start-up or recruitment, and those that have a novel IMP that often cause difficulties in the pharmacy.

Please contact the Gaea Clinical Project Manager, Rebecca White, to arrange a suitable time slot. We can't improve the coffee but we can try to meet your project needs.
Email: rebecca.white@gaea.co.uk

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11th May 2014:

U.K.'s NICE throws Astellas a bone on Xtandi--or does it?

Gaea spent 3.5 years representing Cougar, the sponsor, in Europe managing the CRO for Cougar`s Abiraterone two phase 3 trials in pre and post docetaxel CRPC, both enrolling 1000 patients in 12 months and with successful FDA audits. Then with Medivation in the PREVAIL phase 3, pre docetaxel, in which we were fixing issues at Eastern Europe and Israel sites. We are delighted to read of the success of both products meeting significant unmet medical needs:

"Both drugs-revolutionary therapies that hit the market in 2011 and 2012, with Zytiga getting the head start--put up big numbers last year. Zytiga raked in $1.7 billion in 2013 sales and Xtandi posted $739 million in the first half alone. Despite Zytiga's first-to-market advantage, analysts have tabbed Astellas' med to eventually overtake it..."

First it was good news, then it was bad news, and now it's good news again for Astellas' prostate cancer treatment Xtandi (enzalutamide) and its recommendation from the U.K.'s National Institute for Health and Care Excellence (NICE). At least it appears that way.

In final guidance, the cost-effectiveness gatekeeper has nixed a proposed limitation on use of the drug for patients who have already been treated with a Johnson & Johnson (JNJ) competitor. But whether it will actually endorse Xtandi in that patient population remains to be seen.

As PMLiVE reports, the watchdog has done away with a January guidance revision that ruled out Xtandi for patients who had taken J&J's hot-selling rival, Zytiga (abiraterone). NICE made the switch after the Japanese drug maker provided new observational data suggesting that some patients may benefit from Xtandi after Zytiga. That doesn't mean NICE is all for Xtandi use in former Zytiga patients, however; on the contrary, NICE said in a statement seen by PMLiVE that there were "too many uncertainties in the evidence" to endorse it, adding that its committee deemed it impossible "at this stage to make a recommendation on the clinical and cost-effectiveness of enzalutamide when given after abiraterone."

Indeed, some are sceptical that the revision provides any meaningful change--including Owen Sharp, the CEO of nonprofit Prostate Cancer UK. "If it transpires in reality that this is a de facto restriction thinly veiled by complex prose, we will be holding relevant parties to account," he told PMLiVE.

Source: PMLiVE

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6th May 2014:

Astellas and Medivation Receive Priority Review from FDA for XTANDI® (Enzalutamide) Capsules In Chemotherapy-Naive Advanced Prostate Cancer

We are delighted to read this, having spent 1 year working with Medivation for the sites in Eastern Europe and Israel to minimise patient discontinuations for non protocol reasons, and to ensure radiographic procedures for the r-PFS endpoint took place on time.

TOKYO and SAN FRANCISCO, May 6, 2014
Astellas Pharma Inc. and Medivation Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the supplemental New Drug Application (sNDA) to extend the indication for XTANDI� (enzalutamide) capsules for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy. This sNDA application was granted Priority Review designation with a stated FDA Prescription Drug User Fee Act (PDUFA) review date of September 18, 2014. XTANDI is currently approved for the treatment of patients with mCRPC who have previously received docetaxel chemotherapy.

The sNDA application is based on the results from the Phase 3 PREVAIL trial evaluating XTANDI as compared to placebo in more than 1,700 chemotherapy-na�ve mCRPC patients. A variation application to amend the European Marketing Authorization Application was submitted to the European Medicines Agency on April 2, 2014.

About the PREVAIL Trial The Phase 3 PREVAIL trial is a randomized, double-blind, placebo-controlled, multi-national trial that enrolled more than 1,700 patients at sites in the United States, Canada, Europe, Australia, Russia, Israel and Asian countries including Japan. The trial enrolled patients with chemotherapy-naive metastatic prostate cancer whose disease progressed on a luteinizing hormone-releasing hormone analogue or after bilateral orchiectomy. The co-primary endpoints of the trial were overall survival and radiographic progression-free survival. The trial was designed to evaluate enzalutamide at a dose of 160 mg taken orally once daily versus placebo.

SOURCE Astellas Pharma Inc.

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7th February 2014:

Medivation and Astellas Announce Final Results for PREVAIL (enzalutamide®)

Medivation Inc. and Astellas Pharma Inc. announced final results on primary and secondary efficacy endpoint for their phase III PREVAIL Trial on 28th January 2014. PREVAIL was set-up to analyse the efficacy of enzalutamide in patients with asymptomatic or minimally-symptomatic chemotherapy-nave metastatic prostate cancer who have previously failed androgen deprivation therapy. A statistically significant overall survival benefit was seen in patients treated with enzalutamide (reduced death rate of 29%) compared to placebo (HR=0.71; p<0.0001) and significantly reduced the risk of radiographic progression or death by 81% compared with placebo (HR=0.19; p<0.0001). Another benefit seen was the median tie to deterioration in a measure of prostate cancer-specific quality of life were 11.3 months for enzalutamide-treated patients and 5.6 months for placebo (HR=0.625; p<0.0001). Gaea is delighted to see such positive results for enzalutamide, having been involved in the Clinical Operations and Quality Management for this phase III PREVAIL Trial, working alongside the sponsor-chosen CRO to reduce premature patient discontinuations, all imaging management and additional CRO Training.

http://www.astellas.com/en/corporate/news/detail/medivation-and-astellas-announ-8.html

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25th January 2014:

Clinical trial evidence supporting FDA approvals varies widely

Downing NS.JAMA. 2014;doi:10.1001/jama.2013.282034.

The quality and scope of clinical trial evidence utilised by the FDA as the grounds for drug approvals is highly variable across indications, with just more than one-third of indications approved on the strength of a single pivotal efficacy trial, according to new study findings, reported in JAMA.

For each of the new drugs evaluated, an investigator determined the pivotal efficacy trials used as grounds for approval. The trials were classified based on 1) randomisation and blinding, 2) primary endpoints ,3) type of comparator, 4) number of treated patients,5) �trial duration and 6) �completion rates.�

The investigators noted the use of "surrogate" outcomes, defined as any endpoint using a biomarker to predict clinical utility.Researchers for the cross-sectional study evaluated publicly accessible FDA documents relating to all novel therapeutic agents approved between 2005 and 2012.

The researchers found that during the study period, the FDA approved 188 new drugs for 206 indications, on the strength of 448 pivotal efficacy trials. Although for each indication the median number of pivotal trials was two, 74 indications (36.8%) were approved on the grounds of a single pivotal trial. Most trials were randomized (89.3%; 95% CI, 86.4-92.2), double blind (79.5%; 95% CI, 75.7-83.2) and used either an active or inactive comparator (87.1%; 95% CI, 83.9-90.2). Among all pivotal trials, the median number of patients enrolled per indication was 760. The approval of 68 indications was backed by at least one pivotal trial with a duration of at least 6 months (33.8%; 95% CI, 27.2-40.4). For 91 indications, pivotal trials using surrogate endpoints as the primary outcome constituted the sole basis of approval (45.3%; 95% CI, 38.3-52.2). Trials using clinical outcomes and clinical scales served as the exclusive grounds for approval for 67 (33.3%; 95% CI, 26.8-39.9) and 36 indications (17.9%; 95% CI, 12.6-23.3), respectively. The features of the trials differed based on therapeutic and indication variables, including therapeutic area, anticipated duration of treatment, orphan status and accelerated approval.

The researchers said although the FDA's regulatory flexibility allows valuable customisation in approving new agents, it should be considered when making therapeutic decisions.

"This variation has important implications for patients and physicians as they make decisions about the use of newly approved therapeutic agents, and has the potential to inform current FDA regulatory approval standards and post market surveillance initiatives," the researchers wrote.

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19th December 2013:

Gaea contracted for Quality Oversight Services for EMA Inspection Preparation

Gaea has been contracted to a UK-biotech company for Quality Oversight Services in an upcoming EMA inspection for sites in North America, Europe (Central and Eastern), Russia and the Ukraine.

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20th November 2013:

Gaea announces a Rescue-CRO phase I project in Solid Tumours

A new rescue-CRO project has been awarded to Gaea for a phase I project in solid tumours in the UK. Gaea will provide project management, monitoring, data management, biostatistics and medical writing services for this project.

"Rescue-CRO projects are always a challenge with sites often left un-motivated from the prior-CRO and the significant time needed to transfer the project to Gaea", said Nigel Goodman - Director of Gaea, "This project is particularly challenging and we look forward to getting started on monitoring GCP-compliance for treated and on-going patients, alongside the challenge of setting up a database for retrospective data from 2007."

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31st August 2013:

Gaea announces a new Phase I/II project in Advanced Ovarian Cancer

Gaea is proud to announce a new contract with a small, European Biotech with an exciting Phase I/II project in advanced Ovarian Cancer. Acting as CRO in Belgium and Germany, Gaea will conduct site selection, start-up, continued monitoring and management and close out of the project. Also providing an experienced Medical Monitor resource to the project to manage patient eligibility and safety questions in the EU-timezone.

Nigel Goodman expressed the following; "Advanced ovarian cancer has a high unmet need, with cure unavailable to these patients and only palliative treatment available. Survival rates for ovarian cancer are currently the poorest for all gynaecological cancers with an overall 5-year survival rate of less than 35%. The opportunity to work in this indication and potentially provide a new therapy for these patients is wonderful, the team is very motivated to make this project a success and provide excellent quality data for the sponsor in this early-phase trial."

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24th August 2013:

European Cancer Congress 2013, Amsterdam

27th September- 1st October 2013

With little over a month before the 17th ECCO -38th ESMO - 32nd ESTRO European Cancer Congress in Amsterdam, Gaea are excited to attend one of the most significant congresses of the year, presenting emerging treatments and strategies for the treatment of cancer.

Gaea's Director will be in attendance for the entire four day event, and will be happy to meet with you to discuss our services as CRO or resourced Clinical Consultancy in Europe and Russia. We have a track record in rescuing trials that are behind in start-up or enrolment, or those that have a novel IMP that often cause difficulties in the pharmacy.

Please contact us through enquires@gaea.co.uk should you wish to arrange a discussion at ESMO'13.

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21st August 2013:

Gaea announces a preferred provider relationship with Lyscaut Medical Imaging Company

With the increase in image-driven endpoints in oncology clinical trials, radiology has become more critical. Radiology services are under great pressure from routine clinical work, so missed scans, slow courier services to central read and time-consuming (often impossible) traditional web-upload all contribute to less effective participation from radiology into clinical trials.

Gaea announces a preferred provider relationship with Lyscaut Medical Imaging Company - a collaboration that will provide Gaea and Lyscaut's clients with an effective management and delivery of image-based clinical trials.

As part of the agreement, Lyscaut will provide end-to-end image support to image-based clinical trials for drugs, devices and vaccines. This support is possible through Lyscaut's principal technology partner Hermes Medical Solutions providing cloud-based image handling.

Lyscaut provides a state of the art cloud-based lean service to enable: image anonymisation and upload, storage and visualisation, processing and transport to the reading network using only an intuitive USB dongle with secure encryption. The actual image visualisation, processing and read can be done at will either in the cloud or on the local workstation depending on the preferences of the authorised user. This role-based access to the images is compliant with international regulatory authorities and allows an adaptive connectivity to specific centres.

Dr Hugo Jansen, CEO and founder of Lyscaut, commented: "The relationship with Gaea allows an offering to the client of integrated workflow handling for both clinical and image data in parallel. Both companies address the small- and mid-sized market which at present is underserved regarding data integration. There simply aren't many independent companies with a proven track record and deep understanding of the process side of image-based studies. The combination of clinical experience, agile project management and advanced technology will create efficiencies bringing down costs and drastically increase the odds of an in-time data lock".

Nigel Goodman, Director and founder of Gaea, added: "We are delighted to announce our new relationship with Lyscaut. It is a natural progression from our successful collaborations to date, and will help to ensure that Gaea continues to successfully manage and deliver full service CRO capabilities. Imaging is often problematic as radiology is busy even without clinical trials. With the Lyscaut image upload via USB dongle connection to a central server we also remove the need for the courier of images and so reduce the time of all involved in managing images at sites. We will be able to benefit our client's development and quality timelines".

Full information on Imaging Services is available on the websites:

www.gaea.co.uk/medical_imaging.htm
www.hermesmedical.com
www.lyscaut.com.

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29th June 2013:

Gaea Announces Feasibility and Start-Up Project in Metastatic Castration Resistant Prostate Cancer (pre-chemotherapy)

Gaea is happy to announce their continued work in mCRPC with a novel therapeutic, having finalised a new project to conduct feasibility and start-up for up to 5 additional centres in the United Kingdom for an ongoing phase II immunotherapy trial. The sponsor's novel approach is to induce balanced humoral and cellular immune responses against multiple cancer antigens in CRPC - which may be superior to investigational therapies only targeting PSA.

The project is challenging as Gaea has been given a 1 month period to identify and quality up to 5 sites, followed by 2 months to complete start-up of the centres with all approvals, contract and budget negotiation. These fully set-up sites will then be passed onto the existing CRO for full site management.

Nigel Goodman explains: "We have a proven track record in driving start and enrolment in CRPC trials since 2009 and are thrilled to be actively involved, particularly with an exciting potential therapy. Our excellent links with top UK sites from our previous work has meant that we will be able to work to the tight start-up timelines and prove our worth. Our very experienced resource in the UK will be leading the local submissions with the sites, alongside contract and budget negotiations to ensure we stay on time with the project. We hope to have a clear impact on this study and help boost their enrolment with the addition of our selected sites".

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31st May 2013:

Proven Success in Enrolment Services for Phase 3 Prostate Cancer Trial

Having completed a 3-month contract working on a phase 3 immunotherapy trial, Gaea is delighted to announce results of a 40% improvement in enrolment in Gaea countries.

"Using a team of highly experienced Clinical Research Associates and Clinical Trial Managers, attending on-site visits and providing remote-support to clinical sites in the UK, Spain, Russia and Israel, we have been successful in increasing enrolment by 40% in a 3-month period", explained Nigel Goodman - Director of Gaea, "through the teams efforts, in both a good collaboration with the chosen top-5 CRO and their own experience we have once again proven Gaeas success in improving enrolment into clinical trials".

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28th May 2013:

Attending ASCO?

Gaea will be attending ASCO 2013 in Chicago, US, from Saturday 1st June to Tuesday 4th June.

We would be delighted to set-up a meeting with you to discuss our services as CRO or resourced Clinical Consultancy in Europe and Russia. We have a track record in rescuing trials that are behind in start-up or enrolment, or those that have a novel IMP that often cause difficulties in the pharmacy.

Please contact Gaea's Clinical Project Manager to arrange a suitable timeslot:
Email: rebecca.white@gaea.co.uk.

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22nd May 2013:

Gaea Announces Feasibility Project in clostridium difficile associated diarrhoea

Gaea is conducting a first feasibility project to assess the viability of a clinical trial in clostridium-difficile-associate diarrhoea. The sponsor company is a virtual biotech focused on the development of an antibody-enriched whey derived from cows' milk for patients with clostridium difficile- associated diarrhoea.

"C.diff is a common nosocomical infection and is an increasingly frequent cause of morbidity and mortality among elderly hospitalised patients" said Nigel Goodman, Director of Gaea, "Just as concerning is the relapse rate for these patients of up to 30%, and the ongoing issue of significant antibiotic overuse. These antibodies, targeted to the causative toxins, have the potential to reduce recurrence rates. In addition, a milk based product is easy to use and offers a potential new line of therapy".

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26th April 2013:

Johnson & Johnson release positive sales growth in Q1 for Zytiga® (abiraterone acetate)

With Zytiga® being approved for use in the pre-chemo CRPC population in early 2013, where there is significant unmet medical need, it is no surprise that Johnson & Johnson (JnJ) were able to release very positive sales figures and predicted growth over 2013. The CEO of JnJ, following the full-year sales results, described the drug as the "most successful oral cancer drug launch of all time".

Between December 2012 and January 2013, Zytiga received approval for use in chemotherapy-nave castration-resistant prostate cancer across the US and Europe respectively. A previous analysis estimated 30,000 patients fitting these criteria, although the Q1 sales figures suggest a larger population.

However, on the horizon is the approval for Medivation's Xtandi® (enzalutamide) in the same population. With the Medivation's PREVAIL study looking to meet its primary (PFS) and secondary endpoint (OS); there could be difficulty ahead of Zytiga as the COU-AA-302 study did not provide statistically significant OS data due to its early halt. In addition, the PREVAIL study is significantly larger (1,700 Vs 1,088) than COU-AA-302, providing even more statistical power to the result. It is also thought that the Medivation product, Xtandi®, will be more effective in the pre-chemotherapy than in the post-chemotherapy setting. In addition, prednisone is not required for this regimen, compared to Zytiga.

Interestingly, in December 2012, the NCCN updated their guidelines to recommend Xtandi for use in men with metastatic CRPC who are not eligible for chemotherapy and for those patients in the pre-Docetaxel metastatic CRPC setting - all due to the ongoing phase III PREVAIL trial.

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20th April 2013:

Gaea Continuing Experience in atypical Haemolytic Uraemic Syndrome

Orphan indications are of great interest to Gaea following a number of market access projects in this field. Gaea is currently performing initial research for a North American biotech with a new human monoclonal antibody in atypical Haemolytic Uraemic Syndrome (aHUS) to identify the potential countries and sites to be selected in a first-in-human trial.

aHUS is a chronic, life threatening disease thought to affect 1 person in 500,000. Ecluzumab (Soliris®) is the first treatment to be recommended for use in this indication, but with a price of ~$163,800 per patient, per year, there are obvious concerns for patients with regards to reimbursement. Treatment for patients has previously been focused on prophylaxis.

"To have the opportunity to work in this indication again, even at this early stage, is very exciting for the team at Gaea. We have excellent links with expert clinicians in this field and are well versed in the magnified problems of running clinical trials in such small populations." Said Nigel Goodman, Director of Gaea, "Our interest in this disease is increased due to the poor treatment options for these patients, as we know the importance of Quality of Life for any patient with whatever disease. To see a new product in development for this indication is wonderful and we hope to continue our work here."

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27th February 2013:

Gaea Announces Role in Global Phase III Prostate Cancer Project Using Vaccinia Virus

Gaea has been taken on-board to provide pharmacy specialist and subject recruitment services in a phase III, chemotherapy na�ve, castration-resistant prostate cancer trial for sites in Israel, Poland, Spain, Russia and the UK. The trial uses a vaccinia virus as its investigational medicinal product, and it is hoped that this trial will improve overall survival in this population of patients.

"We are thrilled to be involved in yet another exciting project in prostate cancer following our work with abiraterone acetate and enzalutamide and even more interested as this uses a product we are familiar with, having worked for two years with a biosafety level 2 virus", explained Nigel Goodman, Director of Gaea. "Our aim is to improve the start-up timelines in sites that are not yet open by using our Pharmacy Specialists to educate the site teams on the investigational medicinal product, alongside resolving any issues identified. The Subject Recruitment Specialists will then be employed to boost enrolment at open sites and provide additional support alongside the sponsor chosen CRO."

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11th January 2013:

Gaea Delighted to Provide Advice to Biotech on Running Trials with an Oncolytic Virus

With two years' experience using an oncolytic virus in a phase III oncology study, Gaea is delighted to have been invited to meet a promising biotech company with a similar product in development.

Nigel Goodman, Director of Gaea, discussed this opportunity; "This is the absolute embodiment of Sharing Our Experience, running the phase III trial with an oncolytic virus for the first time in many centres was not without its issues. For small-mid sized companies at the beginning of their development in phase I or II we can help to remove the unknown of such projects by sharing our experience with such products and helping the team identify and overcome issues before they continue development. Even sharing small recommendations such as countries and sites that have known issues with oncolytic viruses can be of huge assistance to these companies, preventing the waste of much time and effort that could be best placed elsewhere."

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8th January 2013:

Difficulties for Clinical Trials in India

It was recently in the media that there have been over 200 cases in India in which patients were unknowingly part of a clinical trial. On 3rd January 2013, the Supreme Court in Dehli ruled that the health secretary was to monitor all new applications for trials from pharmaceutical companies (1).

India is a popular location for pharmaceutical companies to target; its already weak laws are poorly enforced, and it is far less costly to run a trial in India than it would be in Europe or the USA. According to the Confederation of Indian Industry, research and development costs can be reduced by up to 60% in phase II and III trials by conducting the trial in the continent (2).

Unfortunately, this has paved the way for uncontrolled experimentation on patients. The judge presiding over the hearing stated that Indians were being used as used as 'guinea pigs' and that 'havoc' was being bought to the country as a result.

Clinical trials are essential to the development of effective therapeutics, and so are normally heavily monitored, tightly regulated and above all, safe. With such unethical and dangerous practises being carried out by certain doctors and companies in India, India is not a place that Gaea would considering operating in until such a time when regulations and laws were strong enough to enforce legal and safe practises helping vulnerable patient populations.

(1) NA (2013). Drug trials causing 'havoc' to human life, Supreme Court says. Available: Click Here For Source / Last accessed 08Jan13.

(2) V, Krishnan. (2012). The Dark Underbelly of India's Clinical Trial Business. Available: Click Here For Source / Last accessed 08th Jan 2013.

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