Bio Screening Industry News

LA Jolla, CA—Fruit flies and humans share most of their genes, including 70 percent of all known human disease genes. Taking advantage of this remarkable evolutionary conservation, researchers at the Salk Institute for Biological Studies transformed the fruit fly into a laboratory model for an innovative study of gliomas, the most common malignant brain tumors.

“Gliomas are a devastating disease but we still know very little about the underlying disease process,” explains John B. Thomas, Ph.D., a professor in the Molecular Neurobiology Laboratory and senior author of the study, which is published in the current edition of the Public Library of Science Genetics. “We can now use the power of Drosophila genetics to uncover genes that drive these tumors and identify novel therapeutic targets, which will speed up the development of effective drugs.”

Better models for research into human gliomas are urgently needed. Last year alone, about 21,000 people in this country were diagnosed with brain and nervous system cancers, Senator Edward M. Kennedy the most famous among them. About 77 percent of malignant brain tumors are gliomas and their prognosis is usually bleak. While they rarely spread to elsewhere in the body, cancerous glial cells quickly infiltrate the brain and grow rapidly, which renders them largely incurable even with current therapies.

Gliomas originate in brain cells known as “glia” and are categorized into subtypes based on how aggressive they appear, with glioblastoma being the most common and most aggressive form of glioma. Their diversity is mirrored by the number of different signaling pathways involved in the generation of these tumors, yet aggressive gliomas all seem to have one thing in common: Most, if not all human glioblastomas carry mutations that activate the EGFR-Ras and PI-3K signaling pathways. Such mutations are also thought to play a key role in developing drug resistance.

“Fruit flies possess homologs of many relevant human genes including EGFR, Ras, and PI-3K,” explains postdoctoral researcher and first author Renee Read, who spearheaded the project. “We developed the Drosophila model to figure out how these genes specifically regulate brain tumor pathogenesis and to discover new ways to attack these tumors.”

When Read activated both signaling pathways specifically in glia in genetically engineered fruit flies, she found that, just as in the mammalian brain, activation of the EGFR-Ras and PI-3K pathways gave rise to rapidly dividing, invasive cells that created tumor-like growths in the fly brain, mimicking the human disease.

“Once I had verified that the fly tumors share key aspects with human gliomas, I could use the model to screen for new genes that are involved in disease process and compare them to the genes that were found as part of The Cancer Genome Atlas’ glioblastoma initiative,” explains Read.

Glioblastoma is one of the first cancers studied by The Cancer Genome Atlas research network, whose goal is to accelerate understanding of the molecular basis of cancer through the application of modern genome characterization technologies such as large-scale genome sequencing.

Like most cancers, gliomas arise from changes in a person’s DNA that accumulate over a lifetime but sorting changes with wide-ranging impacts from innocent bystanders has been a challenge. “While these initiatives give us big lists of altered genes they don’t tell us much about which ones are really important,” says Read. “Addressing this question in mouse models or patient studies is extremely expensive and time-consuming. In flies, I can test hundreds of genes every week.”

The Salk researchers are now using their fly model to search for genes and drugs that might block EGFR/PI-3K-associated brain tumors. The drug tests are being done in collaboration with co-authors professor Webster Cavenee, Ph.D., and associate professor Frank Furnari, Ph.D., both experts in human brain tumor biology at the Ludwig Institute for Cancer Research at the University of California, San Diego.

The researchers are hoping that through their combined efforts new discoveries from the fly model can be rapidly translated into mouse and human brain tumor studies and lead to development of new therapies for this deadly cancer.

Names World-Renowned Cancer Drug Expert Dr. Joseph Rubinfeld as Chief Scientific Advisor

LOS ANGELES–(BUSINESS WIRE)–CytRx Corporation (NASDAQ: CYTR) today unveiled its corporate strategy to focus its internal resources on the clinical development of oncology drug candidates tamibarotene and INNO-206, which the Company believes offer the greatest mix of near-term and medium-term revenue potential among its clinical assets. CytRx will pursue partnerships to advance the clinical development of INNO-406 (bafetinib) and its clinical molecular chaperone portfolio, where it continues to see significant future revenue potential. The Company further intends to use its proprietary high-throughput, high-content drug screening Master Chaperone Regulator Assay (MaCRA) platform to discover additional molecular chaperone drug candidates, including those that may inhibit cancer growth, which will support internal efforts to build an oncology drug franchise or future out-licensing possibilities.

CytRx also announced that Board of Directors’ member Dr. Joseph Rubinfeld has accepted the additional responsibility of Chief Scientific Advisor, and will consult on all aspects of the Company’s oncology development programs while serving as an important interface between the Company and investors, clinicians and industry thought leaders. Dr. Rubinfeld brings substantial expertise in oncology and drug development through his distinguished career. Dr. Rubinfeld was employed at Bristol-Myers Company International Division as Vice President and Director of Research and Development. While at Bristol-Myers, Dr. Rubinfeld was instrumental in licensing the original anticancer line of products, including Mitomycin and Bleomycin. Among other accomplishments, he was among the four co-founders of Amgen, Inc., and founded SuperGen, Inc., where he previously served as CEO, President and Chief Scientific Officer. In his career he has been instrumental in the development of several blockbuster cancer drugs including cisplatinum, etoposide, erythropoietin, decibitene and pentostatin, and the antibiotics amoxicillin and cefadroxil.

Steven A. Kriegsman, CytRx President and CEO said, “We feel that our stockholders are best served by a focus on potential therapeutics for cancer. We believe tamibarotene has strong potential as a revenue generator with a high likelihood for rapid U.S. approval as a third-line treatment for acute promyelocytic leukemia (APL). Our view is based on the substantial clinical history of tamibarotene as an approved treatment of relapsed APL, in Japan and the existing special protocol assessment (SPA) in place with the U.S. Food and Drug Administration (FDA) for our ongoing U.S. registration clinical trial. We are accelerating enrollment in this clinical trial, with the expectation of filing an NDA with the FDA as early as 2010. We are also taking steps to move into a Phase 2 clinical trial with INNO-206, our highly promising targetable pro-drug for the commonly prescribed chemotherapeutic doxorubicin. We believe that INNO-206 could be effective in a wide variety of cancers, including small cell lung cancer, sarcoma, breast and ovarian cancer and Non-Hodgkins Lymphoma.

“Importantly, we expect that we have ample financial resources with our current cash position and investment in RXi Pharmaceuticals Corporation to support this strategy,” according to Mr. Kriegsman. “We have strong oncology expertise within CytRx and are delighted that Dr. Joseph Rubinfeld, our long-time board member who has enjoyed an illustrious career developing cancer drugs, will be taking a leadership role in our oncology programs.”

Dr. Rubinfeld said, “Having reviewed the extensive data on tamibarotene and INNO-206, I am excited about the potential for these two cancer drug candidates and look forward to working closely with the CytRx management team to advance their clinical development to potential commercialization. I am also encouraged by the Phase 1 data we announced earlier this month with INNO-406, now known as bafetinib, which demonstrated positive, clinical responses in 35% of patients with refractory chronic myeloid leukemia. I believe these results will be instrumental in our search for a partnership for bafetinib.”

Mr. Kriegsman added, “We also stand behind our view that our orally administered molecular chaperone drug candidates, arimoclomol and iroxanadine, provide enormous potential in addressing large, underserved markets and are convinced that the prudent course to maximize stockholder value in this economic climate is to pursue pharmaceutical partners to share additional development costs for these longer-term programs. We intend to complete our ongoing arimoclomol animal toxicology studies and work aggressively toward lifting the current clinical hold in order to enable this drug candidate to move back into the clinic. At that point, we will seek partners for further development of arimoclomol as a therapeutic treatment for both ALS and stroke recovery. Additionally, iroxanadine has shown significant potential as a therapeutic treatment for diabetic foot ulcers and other diabetic complications, and based on Phase 2 data, we will pursue potential partnerships in cardiovascular conditions.”

CytRx’s drug portfolio includes the following:

Oncology Drug Candidates:

Tamibarotene: CytRx holds the North American and European rights to tamibarotene, a rationally designed, synthetic retinoid compound designed to potentially avoid toxic side effects of the current first-line APL treatment trans-retinoic acid (ATRA). CytRx is actively enrolling patients in a Phase 2 registration clinical trial, known as STAR-1, with tamibarotene to evaluate its efficacy and safety as a third-line treatment for APL. The registration study is being conducted under a Special Protocol Assessment. The FDA has granted Orphan Drug Designation and Fast Track Designation for the use of tamibarotene in patients with relapsed or refractory APL following treatment with ATRA and arsenic trioxide.

There are currently no approved third-line treatment options for refractory APL patients. CytRx estimates the U.S. market opportunity for tamibarotene in refractory APL at approximately $20 million annually. CytRx scientists are also evaluating clinical strategies for developing tamibarotene as a first-line or second-line APL therapy. The estimated annual market potential in the U.S. and Europe for an expanded label including refractory, maintenance and front-line therapy is $150 million. CytRx also retains an option to expand its licenses for the use of tamibarotene in other cancers including multiple myeloma, myelodysplastic syndrome and certain solid tumors in the U.S., and multiple myeloma, myelodysplastic syndrome and solid tumors, other than hepatocellular carcinoma, in Europe.

INNO-206: This pro-drug derivative of the commonly prescribed chemotherapeutic agent doxorubicin is designed to reduce adverse events by controlling drug release and preferentially targeting the tumor. In a Phase 1 study, INNO-206 was administered in doses at up to six times the standard dosing of doxorubicin without an increase in observed side effects over those historically seen with doxorubicin. Objective clinical responses were seen in patients with sarcoma, breast and lung cancers. The Company plans to evaluate further clinical development of INNO-206 in a wide variety of cancers, including sarcomas, breast and ovarian cancer, and Non-Hodgkins Lymphoma.

INNO-406 (bafetinib): INNO-406 (bafetinib), a potent, orally available, rationally designed, dual Bcr-Abl and Lyn-kinase inhibitor, is being evaluated for the treatment of patients with chronic myeloid leukemia (CML) and other leukemias that have a certain mutation called the Philadelphia Chromosome (Ph+) and are intolerant of or resistant to imatinib (Gleevec^®) and second-line tyrosine kinase inhibitors (i.e. dasatinib (Sprycel^®) and nilotinib (Tasigna^®)). In November 2008, CytRx announced that bafetinib demonstrated positive, clinical responses in 35% of patients with CML in Phase 1 clinical testing. The Phase 1 clinical trial was used to determine the optimal dose prior to Phase 2 clinical efficacy testing.

CML is a type of cancer that starts in blood-forming cells of the bone marrow and invades the blood. In 2007, the American Cancer Society estimated that approximately 4,600 new cases of CML were diagnosed in the U.S. and that the number will increase as the population ages. Current estimates are that worldwide CML prevalence will increase by 10,000 patients a year, reaching a population of 110,000 in 2010. The global market will grow to an estimated $5.5 billion by 2012.

Molecular Chaperone Regulation

CytRx is a leader in molecular chaperone regulation technology. The Company currently has two orally administered, clinical-stage, drug candidates and recently discovered a series of additional compounds that may provide a pipeline for additional drug candidates. The Company’s drug candidates are believed to function by regulating a normal cellular protein repair pathway through the activation or inhibition of “molecular chaperones.” Because damaged proteins are thought to play a role in many diseases, activation of molecular chaperones that help to reduce the accumulation of misfolded proteins may have therapeutic efficacy in a broad range of disease states. Similarly, CytRx believes that the inhibition of molecular chaperones that normally help protect cancer cells from toxic misfolded proteins may result in the selective destruction of cancer cells.

• Arimoclomol: This molecular chaperone regulator drug candidate is being considered as a treatment for amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease) and stroke recovery. Arimoclomol has been studied in seven Phase 1 and two Phase 2 clinical trials without any significant adverse events. CytRx’s Phase 2b clinical trial with arimoclomol as a treatment for ALS was placed on clinical hold by the FDA in January 2008, unrelated to any data generated by human studies, and additional preclinical toxicology studies are underway to resolve this issue.
• Iroxanadine: CytRx believes that this orally available small molecule compound represents a potentially powerful breakthrough in the treatment of vascular diseases that are caused in part by damage to “vascular endothelium” that lines the inside of blood vessels. CytRx believes that endothelial dysfunction plays a key role in the development of various vascular diseases or their complications including diabetic ulcers, thrombosis, retinopathy, and peripheral artery disease. Preclinical and clinical studies with iroxanadine indicate that it has therapeutic potential for the treatment of cardiovascular atherosclerosis. According to the National Heart, Lung & Blood Institute, atherosclerosis is a leading cause of illness and death in the U.S. and affects approximately 4.6 million people annually.

CytRx San Diego Laboratory: The CytRx San Diego Laboratory is using the Company’s proprietary Master Chaperone Regulator Assay (MaCRA), a cell image-based screening tool that enables the rapid and quantifiable screening of large numbers of small molecule compounds. This technology is used to identify potential drug candidates that modify the activity of a protein known as heat shock transcription factor 1 (Hsf1) and consequently control entire groups of molecular chaperone proteins that repair or degrade toxic misfolded proteins present in diseased cells. Evaluation of the compounds identified in the screen has shown that they exhibit cytoprotective properties in cell culture models of disease. This platform has broad applicability to a range of therapeutic areas, through its ability to identify drug candidates that can either inhibit or amplify molecular chaperone activity. Information related to the development of MaCRA for compound screening was published in the November 2008 issue of the peer-reviewed Journal of Biomolecular Screening.

CytRx Oncology Expertise

Collectively, CytRx’s management and its Board of Directors have brought numerous cancer drugs to market. In addition to Dr. Rubinfeld, the senior managers and directors of CytRx who hold significant oncology experience include: Max Link, Ph.D., Chairman of the Company’s Board of Directors since 1996, who served for a number of years as Chairman and CEO of Sandoz Pharma as well as a director of Alexion Pharmaceuticals, Inc., Celsion Corporation and Discovery Laboratories, Inc.; Jack R. Barber, Ph.D., Chief Scientific Officer, who has significant R&D experience in oncology at Immusol and Viagene, where he most recently served as Head of Oncology; and Shi Chung Ng, Ph.D., Senior Vice President of Research and Development, who has substantial R&D experience at companies such as Abbott and ArQule, Inc., and most recently served as Vice President of Molecular Oncology at Ligand Pharmaceuticals.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development company engaged in the development of high-value human therapeutics. The CytRx drug development pipeline includes programs in clinical development for cancer indications, including tamibarotene in a registration study for the treatment of acute promyelocytic leukemia (APL). CytRx is developing two drug candidates based on its industry-leading molecular chaperone technology, which aims to repair or degrade misfolded proteins associated with disease. The Company owns and operates a research and development facility in San Diego. CytRx also maintains a 45% equity interest in publicly traded RXi Pharmaceuticals, Inc. (NASDAQ: RXII). For more information on the Company, visit www.cytrx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks relating to the outcome or results of any pre-clinical or clinical testing of CytRx’s potential oncology or molecular chaperone drug candidates, including tamibarotene as a third-line treatment for APL, risks related to CytRx’s ability to enter into partnerships to advance the clinical development of INNO-406 and its clinical molecular chaperone portfolio, uncertainties related to the impact of the FDA’s clinical hold on the Company’s arimoclomol clinical trial for ALS on the timing and ability to resume clinical testing at the desired dosage of arimoclomol, the risk that any requirements imposed on the Company’s planned clinical trial designs for ALS or stroke recovery by the FDA as a result of the concerns expressed in their clinical hold of the Company’s ALS program might adversely affect the Company’s ability to demonstrate that arimoclomol is efficacious in treating ALS or stroke patients or cause the Company to cancel one or both of those trials, risks related to CytRx’s need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, risks related to the future market value of CytRx’s investment in RXi and the liquidity of that investment, and the risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx’s most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

LEXINGTON, Mass. (USA), and HEIDELBERG, Germany, Oct. 20, 2008 - The German Cancer
Research Center, also known as DKFZ, in Heidelberg (Germany) chose febit´s newly
introduced Geniom® RT Analyzer to investigate the association of microRNAs (miRNAs)
and cancer.

miRNAs are small pieces of RNA with a maximum length of 23 nucleotides, which have
become an important focus of life-science research in the past couple of years.
Since they do not encode any proteins, they remained largely unappreciated for many
decades. Recently, however, scientists began to realize their crucial role in the
regulation of intracellular events such as differentiation or apoptosis of cells.
The number of miRNA being discovered is growing by the day.

DKFZ scientists therefore searched for a technology that would allow them to keep
pace with the rapidly evolving miRNA databases, continually incorporating the latest
information into their research on the role of miRNAs in carcinogenesis. The newly
developed Geniom RT Analyzer ideally meets this requirement: it exploits freely
configurable biochips produced on demand at febit for microarray analysis of miRNA
profiles in biological samples.

“Our positive experience with the flexibility of febit´s Geniom contributed to our
decision to use the new Geniom RT Analyzer,” said Joerg Hoheisel, director of the
DKFZ Functional Genome Analysis Division. “Preliminary tests indicate an excellent
quality of microarray analysis. In addition, my team is enthusiastic about the
straight-forward operation and outstanding efficiency of the instrument.”

In addition to flexibility, the Geniom RT Analyzer offers a high degree of
automation and nume­rous user-friendly features: all steps in the workflow,
including sample addition, hybridization, staining, washing, shaking and detection,
are performed in one single instrument requiring a minimum of operator time. The
efficient operation results with minimal error rates and offer consistent
experimental parameters providing highly reproducible results. Data read out by the
Geniom Wizard software may then be analyzed with standard software solutions.

In addition to miRNA analysis, the Geniom RT Analyzer offers a variety of other
high-performance applications. For example, a patented biochip protocol enables the
fragmen­tation and sorting of large genomes in smaller well-defined fractions.
Without this essential fractionation step, the complexity of the genomic DNA would
preclude any effective analysis. These may then serve as samples in mutation
analysis and high-throughput sequencing with next-generation sequencers.

febit’s new Geniom RT Analyzer combines extraordinary flexibility with a high degree
of automation for microarray analysis. (Photo: febit)

About febit

febit enables scientists to read, write and understand the code of life: DNA. With
its unique Geniom technology and services, febit is the only company that puts the
control of simplified genomic research in the hand of the user. The seamless
integration of DNA synthesis and analysis and the superior support in experiment
design and bioinformatics helps to understand data and turn it into results. febit’s
team of experienced scientists is dedicated to support customers to solve the
challenge of understanding biological processes. Geniom is a technological and
service platform successfully implemented in basic and applied research by renowned
institutions and companies. Geniom exploits cutting-edge microarray technology for
analysis and synthesis of genes and genomes, providing superior time- and
cost-efficiency combined with an unsurpassed spectrum of applications.

For more information about febit and its products please visit

www.febit.com

About the DKFZ, Division of Functional Genome Analysis

Research at the division of Functional Genome Analysis at the DKFZ (German Cancer
Research Center) aims at the development and immediate application of new
technologies for the production and processing of molecular information at a global
cellular level. The overall objectives are an analysis, assessment and description
of the realisation of cellular function from genetic information as well as the
understanding of the regulation of the relevant processes. Many projects are pursued
in national and international collaborations and programmes.

For more information on Functional Genome Analysis at the DKFZ, please visit
www.dkfz.de/funct_genome/

Detection may be used to complement and target screening for the disease; findings will be integrated into the deCODEme(TM) personal genome scan.

Last update: 1:30 p.m. EDT Sept. 14, 2008
REYKJAVIK, Iceland, Sept 14, 2008

DCGN and colleagues at Radboud University Medical Center in the Netherlands today report the discovery of two common single-letter variants in the human genome (SNPs) that confer increased risk of urinary bladder cancer. Approximately 20% of people of European descent carry two copies of the first variant, a version of a SNP on chromosome 8q24, putting them at a 50% higher risk of developing bladder cancer than those without the variant. Individuals who carry two copies of a common version of another SNP on chromosome 3 were found to be at a 40% higher risk of the disease than non-carriers. These are the best-replicated genetic variants ever linked to bladder cancer risk, and the study analyzed genotypic data from more than 40,000 patients and controls from Iceland, the Netherlands and eight other European countries. The paper, entitled ‘Sequence variant on 8q24 confers susceptibility to urinary bladder cancer,’ will appear today in the online edition of Nature Genetics at www.nature.com/ng.
“In all cancers, the ability to identify individuals at high risk, screening them intensively and intervening early, is the key to improving prevention and outcomes. We expect that the detection of these and other risk variants will soon be employed to complement the assessment of standard risk factors for bladder cancer. As with all of our discovery work, we seek to publish our findings and establish a solid intellectual property position in order to bring these swiftly into the healthcare arena, and have already folded today’s findings into our deCODEme(TM) personal genome analysis service. At the same time, we are working to identify the common thread of variants we and others have discovered on chromosome 8q24 that confer risk of several forms of cancer, including prostate, breast, colorectal and now bladder. If a common molecular mechanism exists, it could provide an important insight into oncogenesis more broadly,” said Kari Stefansson, CEO of deCODE.
For a more detailed discussion of today’s findings you can watch a video discussion between Dr. Stefansson and Dr. Simon Stacey on our blog, at www.decodeyou.com.
Urinary bladder cancer is the sixth most common type of cancer in the United States. It is estimated that 68,810 individuals will be diagnosed with bladder cancer in the United States during 2008 and that 14,100 people will die of the disease. Bladder cancer has been linked to exposure to various types of toxic substances such as cigarette smoke and industrial chemicals. Although it has been known for some time that genetic factors also play a significant role, identifying validated genetic risk variants had been problematic. Incidence of bladder cancer varies considerably between ethnicities, and as the risk factors reported here were discovered by analyzing DNA from groups of European descent, it is our hope that the publication of these findings will contribute to the swift analysis of the impact of these variants in cohorts of other continental ancestries.
The authors wish to thank the thousands of patients and control subjects who participated in this study, and acknowledge the assistance of national cancer registries that worked to identify potential participants. Data and sample collection in Iceland and the Netherlands was funded in part by European commission grants LSHC-CT-2005-018827 and LSHM-CT-2004-005166.
About deCODE
deCODE is a biopharmaceutical company applying its discoveries in human genetics to the development of diagnostics and drugs for common diseases. deCODE is a global leader in gene discovery — our population approach and resources have enabled us to isolate key genes contributing to major public health challenges from cardiovascular disease to cancer, genes that are providing us with drug targets rooted in the basic biology of disease. Through its CLIA-registered laboratory, deCODE is offering a growing range of DNA-based tests for gauging risk and empowering prevention of common diseases, including deCODE T2(TM) for type 2 diabetes; deCODE AF(TM) for atrial fibrillation and stroke; deCODE MI(TM) for heart attack; deCODE ProCa(TM) for prostate cancer; and deCODE Glaucoma(TM) for a major type of glaucoma. deCODE is delivering on the promise of the new genetics.(SM) Visit us on the web at www.decode.com; on our diagnostics site at www.decodediagnostics.com; for our pioneering personal genome analysis service, at www.decodeme.com; and on our blog at www.decodeyou.com.
Any statements contained in this presentation that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results, and the timing of events, to differ materially from those described in the forward-looking statements. These risks and uncertainties include, among others, those relating to our ability to obtain financing and to form collaborative relationships, uncertainty regarding potential future deterioration in the market for auction rate securities which could result in additional permanent impairment charges, our ability to develop and market diagnostic products, the level of third party reimbursement for our products, risks related to preclinical and clinical development of pharmaceutical products, including the identification of compounds and the completion of clinical trials, the effect of government regulation and the regulatory approval processes, market acceptance, our ability to obtain and protect intellectual property rights for our products, dependence on collaborative relationships, the effect of competitive products, industry trends and other risks identified in deCODE’s filings with the Securities and Exchange Commission, including, without limitation, the risk factors identified in our most recent Annual Report on Form 10-K and any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. deCODE undertakes no obligation to update or alter these forward-looking statements as a result of new information, future events or otherwise.

SUNDAY, Sept. 14 (HealthDay News) — Researchers have identified a new genetic player in the development of colon cancer.

September 4th, 2008 - Tocris Bioscience announced today the signing of an exclusive deal with AstraZeneca to supply Gefitinib (also known as Iressa  and ZD1839) to preclinical researchers working on the mechanisms underlying cancer development. For the first time, scientists will be able to buy authentic, fully licensed, non-formulated Gefitinib as an off-the shelf product for use in biological research.

In recent years pharmaceutical companies have developed a number of small molecule drugs that are clinically effective against certain types of cancer. Tyrosine kinase inhibitors (TKIs) such as Gefitinib are at the forefront of this new generation of targeted anticancer agents.

Gefitinib is an EGFR-TKI (epidermal growth factor tyrosine kinase inhibitor), which targets and blocks the activity of the EGFR-TK, an enzyme that regulates intracellular signalling pathways implicated in cancer cell proliferation and survival. Growth factor signalling has been identified as a key driver of tumour growth and spread in a wide range of cancers. For clinical use, Gefitinib has been approved for the treatment of advanced Non Small Cell Lung Cancer (NSCLC) in 36 countries.

This molecule has been licensed to Tocris for use as a preclinical research compound only. Strict conditions have been imposed by AstraZeneca to ensure that it is not used in human studies.

Duncan Crawford, Tocris’ Chief Scientific Officer, said, “We know that there is a great deal of interest in Gefitinib from the global research community. By making fully licensed Gefitinib available through our catalogue, we hope to promote new and exciting research in the fundamental processes that drive cancer development. For Tocris this important new product perfectly compliments our comprehensive and expanding range of high purity compounds, which are in use worldwide to further biomedical research. We are delighted that our excellent relationship with AstraZeneca has allowed us to make this compound available to scientists working on the fundamental mechanisms of cancer cell biology”

About Tocris Bioscience
Tocris Bioscience is a leading supplier of high performance chemicals, peptides and antibodies, with customers in virtually all of the world’s major pharmaceutical companies, universities and research institutes. The Company is committed to making new life science discoveries possible by providing the highest performing and most innovative range of research reagents.

Tocris Bioscience products are used by scientists carrying out non-clinical research in fields such as cancer, stroke, Alzheimer’s disease and obesity. The Company’s product range of over 2,000 reagents represents a unique collection of novel, exclusive and licensed research tools. A major source of key signal transduction reagents and arguably the world leader in the supply of neuroscience reagents, the Company won the Queen’s Award for Enterprise (International Business) in 2002.

Tocris Bioscience is the trading name for the companies in the Tocris Cookson Group. Formed from the 1994 merger of Tocris Neuramin and Cookson Chemicals, Tocris Cookson Ltd is privately held and headquartered in Bristol, UK. Its US subsidiary, Tocris Cookson Inc, is located in St. Louis, Missouri, USA. There are approximately 50 employees in the Group worldwide, operating out of two sites in the UK and one in the US.

About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world’s leading pharmaceutical companies with healthcare sales of $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit: www.astrazeneca.com

WA researchers have taken the first step towards developing new anti-cancer medications that could activate a gene shown to block the growth of cancerous cells.

Led by Western Australian Institute for Medical Research (WAIMR) Director Professor Peter Klinken, the scientists have screened a large collection of drug-like molecules and recently identified a number of compounds which can increase levels of the Hls5 gene.

“This discovery is very encouraging and a great step forward in our quest to create new cancer treatments,” said Professor Klinken.

“Because of the role Hls5 plays in keeping cell growth at a normal rate, we expect that these compounds will greatly slow down the growth of cancer cells.”

The Hls5 tumour suppressor gene was reported by Professor Klinken’s team in 2004.

The group’s research has revealed that people who don’t have the gene - or those who have a mutated or inactive form of the gene - are more likely to develop certain types of cancer.

In conjunction with WA-based biotechnology company BioPharmica, the WAIMR team has spent more than a year screening 70,000 compounds which increase Hls5 levels.

“Our preliminary data reveals that several of these compounds do indeed markedly slow down the growth of human cancer cells,” said Professor Klinken.

“Importantly, we also know through computer modeling that nearly all of these compounds have drug-like qualities.”

“From here, we take the research to the next phase of laboratory testing with the ultimate hope of investigating if one of these molecules can be used to create a fresh treatment that can slow growth of cancer cells in patients.”

Healthcare company AstraZeneca Plc (AZN: News, Chart, Quote ,AZN.L: News, Chart, Quote ) said Friday that it signed an innovative new partnership with the National Cancer Centre Singapore, or NCCS, and the National University Hospital, or NUH, for development of anti-cancer compounds. The collaboration is spelt out in a Memorandum of Understanding, or MOU.

As per the MOU, AstraZeneca and the Singapore institutions will enter into a collaborative agreement that spans both clinical and pre-clinical development activities.

AstraZeneca noted that the partnership also includes a Training Programme placement with the Manchester Cancer Research Centre, with whom AstraZeneca has a formal research alliance. Singapore Economic Development Board partly supports the training programme. The purpose of the training programme is to train a pool of clinical research professionals for both private-sector and public-sector research labs.

According to AstraZeneca, the partnership aims to further build its drug development capabilities in Asia and ultimately accelerate access to new medicines of potential benefit to patients with inoperable Hepatocellular Carcinoma, or HCC. HCC is a cancer that is particularly prevalent in Asia and accounts for approximately one million deaths annually worldwide.

Under the terms of the clinical development collaboration, NCCS and NUH can access AstraZeneca compounds that have already undergone initial clinical testing in the West.

The institutions have already identified AstraZeneca’s two compounds for clinical screening in inoperable HCC during 2008 and 2009. The company stated that more compounds would be made available at a rate of one per year, for the duration of the partnership, which exists until 2012.

For both clinical and pre-clinical activities, AstraZeneca maintained the alternative to presume further development and marketing of all drugs made available as part of the partnership deal.

AZN closed Thursday’s regular trade at $49.04, up $0.34, on a volume of 1.2 million shares.

Carlsbad, Calif., and Beltsville, Md., May 7, 2008 – In research demonstrating that RNA previously thought to have no biological relevance may be of use for therapeutic and diagnostic targets, Invitrogen Corporation (NASDAQ:IVGN), a provider of essential life science technologies for research, production and diagnostics, and BioServe, the leading provider of clinically annotated tissue samples and provider of molecular marker research services, today announced that their technologies identified noncoding RNAs that were differentially expressed in healthy and diseased tissue. These micro ribonucleic acid (miRNA) sequences were either up or down-regulated between matched samples of RNA isolated from healthy colon and colorectal cancer tissues.  Data was presented in a poster at the annual meeting for the American Association for Cancer Research.

Invitrogen researchers used RNA samples from BioServe’s OncoRNA (http://www.bioserve.com/products/oncoRNA.cfm) product line, a series of RNAs isolated from fresh-frozen, fully annotated tumor and adjacent normal tissues, to probe the Ncode(TM) Human miRNA microarray V3.  Ncode(TM) Profiler software identified miRNAs that were either up- or down-regulated in tumor versus healthy tissue, and researchers used quantitative PCR to validate the findings.

“Using the high quality RNA samples from BioServe, we were able to identify novel microRNA sequences that could potentially be involved in the generation of new tumor tissues, particularly in colorectal cancer,” said Chris Adams, research and development leader of Epigenetics at Invitrogen.  “If more stringently validated, these disease-related microRNAs may eventually serve as targets for diagnostic or therapeutic development.”

MicroRNAs are short RNA sequences that do not code for specific proteins but are extremely important in the regulation of gene expression; they are implicated in several disease states including cancer and heart disease.  Among the activity of miRNAs is the triggering of messenger RNA (mRNA) degradation and the inhibition of protein translation – the process of assembling amino acids into proteins based on the instructions contained in mRNA sequences.  Invitrogen’s Ncode(TM) Human miRNA microarray V3 consists of miRNA content from multiple sources, including the Sanger 10.0 miRNA database and novel miRNAs unavailable in public databases, giving users access to strong content for identification and study of miRNAs.

“MicroRNA is making headlines in drug discovery for its ability to fine tune the activity of genes and its part in the formation of cancer,” said Kevin Krenitsky, chief executive officer, BioServe. “This makes it all the more critical that researchers can be certain they are working with stable, highly annotated samples collected under rigorous ethical and scientific protocols. We created OncoRNA to respond to this need, providing bench-ready RNA for tomorrow’s discoveries.”

About BioServe

BioServe is a leader in the processing, development, and validation of diagnostic tests for the practice of personalized, predictive and preventive medicine. Leading pharma, biotech and diagnostic firms collaborate with BioServe to identify and validate markers that cause disease while correlating clinical and molecular data to develop new diagnostic tests promoting wellness around the world. BioServe offers the Global Repository(R), a growing library of over 600,000 human DNA, tissue and serum samples linked to detailed clinical and demographic data from 140,000 consented and anonymized patients from four continents. Leveraging BioServe’s robust genomic analytical services, technology, Global Repository and CLIA-certified laboratory, collaborators gain a complete, highly efficient platform for processing diagnostic test results and identifying genomic markers for powerful new assays. BioServe has headquarters in Beltsville, MD and Hyderabad, India. For more information please visit www.bioserve.com or call 301-470-3362.

About Invitrogen

Invitrogen Corporation (NASDAQ:IVGN) provides products and services that support academic and government research institutions and pharmaceutical and biotech companies worldwide in their efforts to improve the human condition. The company provides essential life science technologies for disease research, drug discovery, and commercial bioproduction. Invitrogen’s own research and development efforts are focused on breakthrough innovation in all major areas of biological discovery including functional genomics, proteomics, stem cells, cell therapy and cell biology — placing Invitrogen’s products in nearly every major laboratory in the world. Founded in 1987, Invitrogen is headquartered in Carlsbad, California, and conducts business in more than 70 countries around the world. The company employs approximately 4,700 scientists and other professionals and had revenues of approximately $1.3 billion in 2007. For more information, visit www.invitrogen.com.

Biomarkers will be accepted as predicted tools, but their clinical usefulness needs to be understood
first, according to personalized medicine expert.

Coordinating personalized medicine on an international level, Dr Edward Abrahams, Executive
Director of the Personalized Medicine Coalition believes that biomarkers will eventually impact all
disease areas.

“When they were validated, and when it can be understood how clinically useful they are, biomarkers will be the easier method to understand the etiology of disease and human wellness,” commented Abrahams.

While the science of personalized medicine is fairly new, it is already being demonstrated in successful approaches to treating breast cancer and HIV. In cancer research in particular, industry is realising the potential of a separate diagnostic readout for every patient to allow for more targeted therapeutics. Abrahams sees biomarkers as “the scalpel that opens the patient,” but despite current success there are also serious issues for the uptake of personalized medicine, such as barriers to market.

The Personalized Medicine Coalition has been set-up to deal with such barriers in all levels of
research across the various industries involved. Evolving business models, demonstrating clinical
utility, and improving training at the bedside are just a few of the barriers that have affected “a clear regulatory pathway to co-develop personalized products,” commented Abrahams.

Despite warning of the serious issue of probability when using biomarkers as predictive tools, Abraham’s view of the future is bright: “I and many foresee a day when we’ll have predictive
biomarkers across all of healthcare.” With successful validation and clinical usefulness, advancing the use of biomarkers in industry will be a key stepping stone towards a personalized approach and the success of the healthcare system in the future.

Reducing healthcare costs will be a vital step to ensuring an effective system is in place for our aging populations; “personalized targeted therapies” may be one way to improve outcomes, with products tailored to each patient group. Highlighting this is one of the goals of the Personalized Medicine Coalition.

“Even if the individual products might cost more money, the system might save money by getting the approach right the first time.”

Hear more from Dr Edward Abrahams during his plenary lecture at the upcoming Informa Life
Sciences’ conference on ‘Advancing Biomarkers for Industry.’ Running alongside a Molecular
Diagnostics meeting, this takes place on 24-25 June 2008 in Brussels, Belgium. Find out more at
www.informa-ls.com/biomarkers