On April 19, 2009 Cancer Research Technology Ltd (CRT) reported that its scientists will present exciting new findings showing that a potent and selective inhibitor of protein kinase D called CRT0066101, inhibits the growth of pancreatic tumours (Press release, Cancer Research Technology, APR 19, 2009, View Source [SID1234523357]).

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The research – to be presented by CRT’s Dr Christopher Ireson at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) conference today (Sunday) – was a collaborative effort between scientists at CRT’s discovery laboratories and the University of Texas MD Anderson Cancer Center. These results show for the first time that an inhibitor of PKD can slow the growth of tumours in pancreatic cancer models. In addition, experiments carried out by CRT have shown that CRT0066101 is also effective at inhibiting the growth of tumours in a lung cancer model. The scientists believe that the drug has the potential to treat other cancers too.

PKD is a relatively newly identified family of serine/threonine kinases comprising PKD1, PKD2 and PKD3. The potential of PKD as a new drug target was discovered by Enrique Rozengurt, Doreen Cantrell and Peter Parker and funded by Cancer Research UK. Following this discovery, an intensive drug discovery effort led by CRT’s Head of Medicinal Chemistry, Dr Tony Raynham, culminated in the identification of CRT0066101 as a lead candidate for pre-clinical studies. Since then, PKD has been identified as playing a central role in the development of a number of cancers. In addition to its role in the growth of tumour cells, PKD has also been shown to play a pivotal role in cell survival and angiogenesis – a process by which tumours form new blood vessels – which is central to tumour growth and spread.

CRT’s discovery laboratories director Dr Hamish Ryder said: "We focused on pancreatic and lung cancer tumours because they represent cancers with a significant unmet medical need. The CRT model of combining promising basic science with the capability of the industrially-focused discovery laboratories gives us a unique opportunity to rapidly develop potential new molecules to novel targets, and through partnering with industry, explore the potential to see if one day it might help treat cancer patients in the future".

Dr Sushovan Guha who leads the laboratory at MD Anderson Cancer Center, said: "We are very optimistic about CRT0066101’s pharmacological potential. We believe this is the first orally administered small-molecule inhibitor of PKD with significant biological efficacy in pre-clinical animal models of pancreatic cancer. My conviction is that we will show the drug can also prevent the proliferation of cancer cells by blocking their supply of blood – through neo-angiogenesis. This would mean it offers a double action treatment but this needs to be proved through further work."

On April 15, 2009 Sanofi-aventis (EURONEXT:SAN) (NYSE:SNY) reported that it has signed a binding agreement for the acquisition of BiPar Sciences, Inc. ("BiPar"), a privately held US biopharmaceutical company, developing novel tumor-selective approaches for the treatment of different types of cancers (Press release, BiPar Sciences, APR 15, 2009, View Source [SID1234523619]).

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BiPar is the leading company in the emerging field of DNA (DeoxyriboNucleic Acid) repair using PARP (Poly ADP-Ribose Polymerase) inhibitors. PARP inhibitors represent a new, targeted approach to treating many types of cancers. By preventing cancer cells from repairing their own DNA, PARP inhibitors ultimately cause cancer cell death.

BiPar’s lead product candidate is BSI-201, a potential first-in-class PARP inhibitor currently being studied in Phase 2 clinical trials in metastatic triple negative breast cancer (TNBC), ovarian cancer and other malignancies.

"We are extremely pleased to join with one of the most successful and innovative global pharmaceutical companies," said Hoyoung Huh, M.D., Ph.D., president and Chief Executive Officer of BiPar Sciences. "This agreement validates BiPar’s novel scientific approach and will maximize patient access to this new class of breakthrough cancer therapy."

"The acquisition of BiPar, one of the pioneer for novel tumor-selective therapies, is a further step in our company’s goal to focus on new approaches to strengthen our oncology R&D portfolio," said Christopher A. Viehbacher, Chief Executive Officer of sanofi-aventis. "This acquisition illustrates our strong commitment to oncology to provide patients, physicians and public health stakeholders with breakthrough medicines addressing unmet medical needs."

Under the agreement, the purchase price will depend on the achievement of milestone payments related to the development of BSI-201, which could achieve a maximum of $500 million.

The closing of the transaction is expected to occur in the 2nd quarter of 2009, subject to the receipt of the FTC clearance.

About Triple Negative Breast Cancer (TNBC)

When patients are diagnosed with breast cancer, their tumors are routinely tested for and classified based on the presence of estrogen, progesterone, and HER2 receptors. Commonly used breast cancer therapies target these receptors. However, up to 20 percent of all breast cancers are negative for all three receptors, thus giving rise to the term "triple negative breast cancer (TNBC)."

TNBC is a difficult-to-treat cancer subtype that does not have an approved standard-of-care and does not respond to current hormone-based and targeted therapies. TNBC is a very aggressive cancer, with higher rates of metastases and poorer survival rates than other breast cancer subtypes. The prevalence of the TNBC subtype is higher in younger and African-American women.

Breast cancer is the most prevalent cancer in the world today and the most common cause of cancer-related deaths among women. It is estimated that 182,000 new cases of invasive breast cancer were diagnosed in women in the U.S. during 2008.

About BSI-201

Among other PARP inhibitors in the industry, BSI-201 is the furthest along in clinical development in TNBC. With first-in-class and best-in-class potential, BSI-201 is highly potent against tumors and inhibits PARP activity for prolonged periods of time. BSI-201 enhances the effect of chemotherapy-induced DNA damage. The development of BSI-201 is supported by a strong safety profile based on studies of more than 200 patients.

Recently, BiPar announced positive interim safety data from an ongoing Phase 2 clinical trial of the company’s PARP inhibitor, BSI-201, in combination with chemotherapy in patients with metastatic triple negative breast cancer (TNBC). The company also presented gene expression data that confirmed significant upregulation of PARP in the tumors of the first 50 patients enrolled in the Phase 2 trial. Results were presented at the recent annual CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) in December 2008.

On March 2, 2009 Cancer Research Technology Limited (CRT), the oncology-focused development and commercialisation company, and the newly established oncology therapeutics company Aura Biosciences reported that they have agreed to take a promising new set of peptides into development for use in targeting cancer (Press release, Cancer Research Technology, MAR 2, 2009, View Source [SID1234523358]). The move marks significant extra investment in a potential treatment which will use these peptides to target cancer cells with RNAi or drug-loaded nanoparticles.

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This deal will further the development of scientific work carried out by Cancer Research UK and DebRA – a charity which works on behalf of people in the UK with the genetic skin blistering condition Epidermolysis Bullosa (EB). Researchers developed short peptides that bind strongly to the protein called integrin avb6*, a cell-surface protein that is over expressed in a wide range of cancers but is not present at high levels in normal healthy tissue. The strong presence of integrin avb6 has been shown to be an indicator of a more aggressive tumours and poorer prognosis for cancer patients in breast cancer and in other tumours.

Dr John Marshall from Queen Mary, University of London – who will lead the study on these peptides said: "We are delighted to be joining forces with Aura Biosciences to develop this technology. We believe it has great potential to target and deliver a therapy to many tumours which over-expresses integrin avb6. This is supported by a wide body of literature showing that integrin avb6 is expressed at high levels in many different cancer types, including some of the cancers which currently have limited treatment options available for them such as pancreatic and head and neck cancer."

The terms of this deal will allow for the scientists at Queen Mary to continue to develop the peptides through a new research evaluation programme, sponsored by and run in collaboration with Aura Biosciences.

Under the terms of the agreement, Aura Biosciences will make payments to CRT in exchange for an option to take an exclusive worldwide licence on the peptides for certain applications – on pre-agreed financial terms which include an upfront fee, development milestones and royalties on future sales. Aura Biosciences will fund and oversee the next stage of the evaluation work. CRT will retain rights to the peptides in all other fields of use.

Dr Elisabet de los Pinos, chief executive officer of Aura Biosciences said: "We are very pleased to be progressing this research as we believe the peptides have exciting potential in combination with our proprietary nanoparticle technology already developed. We hope this collaboration will help us provide a unique way to target our nanoparticles to tumour sites more specifically."

Dr Phil L’Huillier, CRT’s director of business management said:"This deal will enable the development of technology which we hope will one day allow doctors to use these peptides to deliver drug-loaded particles directly to the tumour, reducing the side effects often associated with standard therapies and improving how well they work."

On February 6, 2009 Cancer Research UK reported that sales of Temozolomide*, an anti-cancer drug developed by its scientists, have reached $1 billion (Press release, Cancer Research Technology, FEB 6, 2009, View Source [SID1234523359]). The charity receives a percentage royalty on these sales, which it uses to invest in new research to beat cancer.

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Temozolomide – a chemotherapy drug for patients with the most common form of brain tumour – was discovered 30 years ago in a Cancer Research UK laboratory led by Professor Malcolm Stevens, then at Aston University in Birmingham.

The charity also undertook the first clinical trials of the drug which proved its activity against glioblastoma multiforme – the most aggressive type of brain tumour accounting for over 50 per cent of all primary cases of the disease.

Based on these phase I and phase II trials – which were managed by Cancer Research UK’s Drug Development Office – the charity’s commercial and development arm Cancer Research Technology (CRT) licensed the drug to Schering-Plough which now markets the drug. The company undertook the pivotal phase III studies which found that temozolomide, when given in combination with radiotherapy, results in a significant increase in survival with minimal side effects.

Dr Keith Blundy, chief executive of CRT, said: "We’re delighted that Temozolomide has achieved sales of over $1 billion. We’re extremely proud of our involvement in the licensing of Temozolomide as it has proved to be an effective treatment for people with brain tumours who otherwise have very limited treatment options.

"The royalties we receive from the sales of Temozolomide go straight back into the pot to fund further research to aid the development of even more drugs to help in our fight against the disease."

The standard of care for glioblastoma multiforme – also known as glioma – includes chemotherapy during and after radiotherapy. The use of temozolomide both during radiotherapy and for six months post radiotherapy is now the gold standard treatment for most cases of the disease. Temozolomide works by killing cancer cells and sensitising them to the effects of radiation.

Harpal Kumar, chief executive of Cancer Research UK, said: "This milestone highlights the significant impact our research is having on cancer drug development. It is testament to the ingenuity of the scientists who developed the original compound as well as the unique capabilities of our drug development and technology transfer teams."

Cancer Research UK scientists have contributed to the discovery or early clinical development of 5-10 per cent of all major cancer treatments currently in clinical use around the world and has taken over 100 new drugs into patients for the first time.

Harpal Kumar continued: "This is just the latest example in a long list of successful treatments that have come out of Cancer Research UK funded research. Our scientists helped to discover and develop two of the most widely used cancer drugs in the world – carboplatin and cisplatin – which are used to treat ovarian, lung and testicular cancer.

"We also have a very exciting pipeline of almost 50 new drugs currently in clinical trials which could provide further significant weapons in the fight against cancer. Of these, several are in phase III development, including three potential new drugs for lung cancer, a disease in which we have sadly made little progress over the past few decades.

"Today’s news is a fantastic example of how the public’s investment, through their generous donations, in Cancer Research UK pays off."

On November 28, 2008 Cancer Research Technology Limited (CRT), the oncology-focused development and commercialisation company, and the technology development specialists The Technology Partnership plc (TTP) reported they have agreed to join forces to progress new lens-free imaging equipment called CyMap (Press release, Cancer Research Technology, NOV 28, 2008, View Source [SID1234523361]).

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CyMap is able to detect a range of particle types in a solution and holds the potential to be used in highly cost-effective medical diagnostics systems* in hospitals, doctors surgeries and research laboratories to detect, quantify and analyse medical samples such as blood or bacteria.

This technology is based on the principle that when illuminated using a simple light source, ‘items’ such as cells or pathogens in a sample create light diffraction** and interference patterns that can be recorded by a charge-coupled device (CCD) – a type of digital camera – and then analysed using computer algorithms. This will enable scientists to count the number of ‘items’ in a sample, and also to monitor changes over time, such as location, movement and division of cells. This information will be useful in helping scientists understand cell division and cell movement, which are important in some normal processes such as wound healing, and in some diseases including cancer.

In the diagnostics field, CyMap may also be developed to monitor bacterial contamination, the presence of other pathogens, or to count red and white blood cells. One of the other advantages of CyMap technology is that it can be easily miniaturised and integrated with microfluidic systems – and it may also have other wider research applications as well.

Professor Borivoj Vojnovic, one of the inventors of the technology at the Gray Institute for Radiation Oncology and Biology, University of Oxford, (GIROB) said: "This new generation of imaging technology will hopefully be much smaller, cheaper and easier to use than the existing alternatives which are usually only available to scientists and pathologists in larger well equipped bioscience laboratories. We envisage CyMap working well as a hand-held device which should make the equipment accessible and affordable for more people working in cancer and other health related disciplines across the world."

The technology was developed by members of the Optical Biochips Consortium, at GIROB, Cardiff University and Bangor University. This Consortium was backed by funding*** from Research Councils UK, which includes the Biotechnology and Biological Science Research Council and the Engineering Physical Sciences Research Council.

The intellectual property arising from this laboratory-based research has been assigned to CRT which has filed a patent to protect the academic work. Under the terms of the agreement announced today, CRT has awarded TTP an exclusive option to license and develop the CyMap technology. TTP will seek other commercial partners to develop and bring to market a range of applications based on CyMap, either by direct licensing arrangements or through co-development partnerships. CRT and TTP will share the revenues arising from any future development and sales of the technology.

Paul Galluzzo, consulant at TTP, said: "We specialise in commercialising technology that holds the potential to make a real difference in sectors such as clinical and consumer diagnostics, drug discovery, consumer products, digital printing, and communications. We frequently work in partnership with the scientists who made the discovery to bring exciting concepts to the marketplace. CyMap is genuinely innovative and we believe it has great commercial potential, for example to enable new diagnostic platforms, and to introduce imaging capability to products where imaging is currently too expensive. The next stage will be to develop the technology for a range of specific product areas."

Dr Phil L’Huillier, CRT’s director of business management said: "We believe this technology is very exciting and it’s great to be able to see it progressed in today’s deal. We hope CyMap will help understand and predict what is happening to patients at a basic biological level. This could, one day, have an impact on treatments and how they are delivered. CyMap technology has the potential to be cheaper, more compact and simpler to use which will hopefully prevent doctors from having to send as many samples to laboratories for analysis and enable quicker and easier monitoring of the samples. Only time will tell if this early stage promise pays off but we will watch its progress eagerly."