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   Biotech / MedicalParadigm Genetics -- PDGM


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To: nigel bates who wrote (79)11/20/2003 9:42:31 AM
From: nigel bates
   of 101
 
Paradigm Genetics Signs Fungicide Evaluation Agreement With Bayer CropScience
Thursday November 20, 8:35 am ET
Screening tests may lead to future licensing agreement

RESEARCH TRIANGLE PARK, N.C., Nov. 20 /PRNewswire-FirstCall/ -- Paradigm Genetics, Inc. (Nasdaq: PDGM - News), a biotechnology company, today announced that it has signed a fungicide evaluation agreement with Bayer CropScience whereby Bayer will test a select number of chemical compounds validated in Paradigm's fungicide screening program. The testing will take place at Bayer's research headquarters in Monheim, Germany. Financial terms were not disclosed.

If the screening tests are successful, Bayer has the option to enter into an exclusive licensing agreement with Paradigm to develop the lead chemicals into commercial fungicides. Under this scenario, Paradigm could receive a combination of research payments, exclusivity payments, milestone payments, and/or royalties for the lead compounds.

"While our partnered programs in herbicide discovery and crop traits occupy center stage in our agricultural business, we have had a successful internal fungicide discovery program in which we've analyzed more than 250 targets and validated more than 50. This program has been supported by a carefully crafted patent strategy, as evidenced by our recently issued U.S. patents," said Keith Davis, Ph.D., Vice President, Agricultural Research of Paradigm Genetics. "In recent months, we've found there to be greater interest in licensing our fungicide assets. This agreement with Bayer represents an important first step in commercializing discoveries resulting from our fungicide program."

In 2003, Paradigm received two U.S. patents that may lead to the development of novel, less toxic fungicides or antifungals, which are highly sought after in the agricultural industry.

The first patent covers a fungicide target found in the fungal lysine biosynthetic pathway as well as methods enabling the discovery of chemicals that inhibit enzymatic steps within the lysine pathway. The second covers the company's proprietary Transposon-Arrayed Gene Knock-Out (TAG-KO®) technology, which covers methods for the rapid and systematic mutation of pathogenic fungi, enabling the efficient identification of novel antifungal and fungicide targets as well as novel biosynthetic and degradation pathways.

The worldwide fungicide market is approximately $6 billion annually. Demand for new fungicides with novel modes of action is expected to remain high due to recurring fungal resistance.

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To: tuck who started this subject12/19/2003 3:22:59 PM
From: tuck
   of 101
 
Rather strange PR. Financial terms mentioned only vaguely only in the headline . . .

>>Paradigm Genetics Signs Three-Year, Multi-Million Dollar Crop Trait Collaboration With Pioneer Hi-Bred International, Inc.
Friday December 19, 1:27 pm ET
Company to use its GeneFunction Factory(R) platform to identify plant genes that influence crop traits


RESEARCH TRIANGLE PARK, N.C., Dec. 19 /PRNewswire-FirstCall/ -- Paradigm Genetics, Inc. (Nasdaq: PDGM - News), a biotechnology company, today announced that it has signed a collaboration agreement with Pioneer Hi-Bred International, Inc., a subsidiary of DuPont headquartered in Des Moines, Iowa, to identify plant genes that influence important crop traits for use in Pioneer's crop variety development program.

For this collaboration, Paradigm will use its high throughput GeneFunction Factory® platform to analyze genes in Arabidopsis thaliana, a model organism, and identify those genes that will enable Pioneer to accelerate the product breakthroughs and improvements it brings to its customers worldwide.

"We are delighted to collaborate with Pioneer as we strive to provide high throughput, cutting edge research results to our agricultural partners. Pioneer is a leader in commercializing agricultural biotechnology, and we are proud to utilize our GeneFunction Factory® as part of their genomics-based trait discovery process," said Heinrich Gugger, Ph.D., president and CEO of Paradigm Genetics. "This collaboration demonstrates that our strategy for expanding and extending our agricultural customer base of partners is both sound and effective. It also demonstrates our continuous efforts to improve our multiple technology platforms for obtaining a greater understanding of biological systems are paying off."

"We are pleased to collaborate with Paradigm and use its functional genomics capabilities," said Bill Niebur, vice president of research, product development for Pioneer. "We believe that discoveries made through this collaboration will complement our established trait discovery programs and will allow us to continue to develop new products that bring value to our customers."<<

snip

Cheers, Tuck

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To: tuck who started this subject1/29/2004 7:02:23 PM
From: tuck
   of 101
 
>>RESEARCH TRIANGLE PARK and PITTSBURGH, Jan. 29 /PRNewswire-FirstCall/ -- Paradigm Genetics, Inc. (Nasdaq: PDGM - News), a biotechnology company, announced today that it has entered into a definitive agreement with TissueInformatics.Inc whereby Paradigm Genetics will acquire TissueInformatics, a privately-held company based in Pittsburgh, Pa., which specializes in the development and application of automated pathology software for the quantitative analysis of tissue changes in drug discovery, disease assessment, toxicology, and tissue engineering. The acquisition will occur through an all-stock transaction in which approximately 3.4 million shares will be issued immediately and approximately 2.7 million additional shares are subject to performance milestones.

This acquisition provides Paradigm Genetics with TissueInformatics' technology to obtain quantitative tissue feature information for use in Paradigm Genetics' biomarker and target discovery efforts as well as a proprietary portfolio of drug targets and diagnostics in diabetes, obesity and aging through TissueInformatics' joint venture with DiAthegen, LLC. It also brings to Paradigm enhanced expertise in pre-clinical development, clinical medicine and pharmaceutical business development.

"The acquisition of TissueInformatics will accelerate the commercialization of our technologies and the building of our own product portfolio in biomarker-enabled drug discovery," said Heinrich Gugger, Ph.D., President and CEO of Paradigm Genetics. "I am also enthusiastic about the opportunities to apply TissueInformatics expertise in quantitative tissue analysis to our agricultural research programs. Most importantly, we believe this acquisition provides Paradigm Genetics with a unique competitive advantage as the first company to combine gene expression profiling, biochemical profiling and quantitative tissue analysis in a systems biology approach to life sciences discovery."

The acquisition of TissueInformatics is a key step in the growth strategy of Paradigm Genetics, providing the Company with direct access to highly quantitative information about tissue structure. The Company expects the acquisition to:

create a unique systems biology platform that enables the quantitative analysis of disease and drug action using a Gene to Cell to System(TM) approach;
significantly strengthen the Company's scientific and commercial position through scientific and commercial synergies in toxicology, target and biomarker discovery as well as assay development;
provide opportunities for an expanded services business that can generate near-term revenue and leverage R&D activities supporting the development of a proprietary pipeline of diagnostics, drug targets and leads; and
better position the Company for near-term and future growth by expanding its offering and gaining access to new potential customers and partners.
The combined Company will offer the following products and services: a unique systems biology platform for life sciences discovery and safety assessment through the combination of gene expression profiling, biochemical profiling and quantitative tissue analysis; advanced research capabilities in biomarker-enabled drug discovery, with an internal focus on diabetes and obesity; Paradigm Array Labs(TM) microarray processing services; commercialization of its TissueAnalytics(TM) automated pathology software for use by pharmaceutical, biotechnology and tissue engineering companies for application in drug discovery and toxicology; and, gene-based discovery of novel herbicide and fungicide targets and plant genes important in crop production, pathway engineering of fine chemicals in plants, and high throughput screens for beneficial agricultural compounds.

Upon closing the transaction, Paradigm Genetics will employ 225 people, be headquartered in Research Triangle Park, NC and maintain current operations in Pittsburgh, Pa. The existing TissueInformatics management team will join Paradigm Genetics. Peter Johnson, M.D., will become Executive Vice President and Chief Medical Officer, and Mark Braughler, Ph.D., will become Vice President, Business Development -- Healthcare. Both will become members of Paradigm Genetics' executive management team and report to Dr. Gugger. Additionally, Todd Joron, MBA, will become Head, TissueAnalytics(TM) Software Business; and Max Fedor, MBA, will become Head, Product Development, TissueAnalytics(TM) Software.

"Paradigm Genetics and TissueInformatics have been partners since March 2003 when we entered into a collaboration to discover biomarkers for chronic liver disease," said Peter Johnson, M.D., Chairman and CEO of TissueInformatics. "Our shared interest in toxicology and metabolic disorders, our similar corporate cultures, our complementary technologies and our vision for future growth make this decision a natural one. Our shareholders recognize the significant opportunity this merger provides to leverage their investment into this unique and exciting biotechnology company. I'm also pleased that this deal recognizes the Pittsburgh region as an emerging player in biotechnology."

Under the terms of the agreement, Paradigm Genetics, which currently has 32.6 million shares outstanding, will issue new shares of Paradigm Genetics Common Stock to TissueInformatics shareholders in a stock-for-stock exchange. Approximately 3.4 million Paradigm Genetics shares will be issued at closing with an additional 2.7 million shares available on an "earn-out" basis for the successful achievement of performance milestones on or before December 31, 2004. These milestones are tied to the attainment of specified revenue levels and new research contracts with corporate customers. Paradigm Genetics will also assume all outstanding TissueInformatics' options and warrants equivalent to approximately 400,000 shares of Paradigm Genetics Common Stock (assuming all performance milestones are met). All shares issued or to be issued are subject to a lock-up period of one year from the date of closing. Upon closing, Paradigm Genetics will receive approximately $2.7 million in cash and assume approximately $150,000 in long-term debt and capital lease obligations.

The acquisition is subject to the approval of TissueInformatics' stockholders and other customary closing conditions and is expected to close in early March 2004. The principal stockholders of TissueInformatics, including TVM V Life Science Ventures, The Manufacturers Life Insurance Company and Aurora Ventures and others, have agreed to vote their shares in favor of the transaction. Needham & Company, Inc. provided a fairness opinion to the Board of Directors of Paradigm Genetics.

The shares of Paradigm Genetics Common Stock issuable in the transaction with TissueInformatics have not been registered under the Securities Act of 1933, as amended, or any state securities laws. Unless so registered, the common stock may not be offered or sold absent an exemption from or transaction not subject to the registration requirement of the Securities Act and any applicable state securities laws. Paradigm Genetics has agreed to register the shares issued to TissueInformatics shareholders prior to the expiration of the lock-up period. This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of common stock in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

Conference Call

Paradigm Genetics' and TissueInformatics' senior management will discuss details concerning the proposed acquisition of TissueInformatics during a special conference call scheduled for January 30, 2004 at 11 a.m. ET. To listen to the call, participants may dial +1-800-289-0468 (US and Canadian callers) or +1-913-981-5517 (International callers) and enter conference ID #563207 or visit www.paradigmgenetics.com where the call will be simultaneously webcast. A replay of the call will be available through February 3, 2004 at midnight by dialing +1-888-203-1112 (US and Canadian callers) or +1-719-457-0820 (International callers) and entering conference ID #563207. The webcast will be archived and available for replay from the Investor Relations page of Paradigm Genetics' website.

About TissueInformatics

TissueInformatics.Inc is the World's Automated Pathology Company. Staffed with seasoned professionals and funded with over $25M in financing from notable investors such as Motorola, TVM V Life Science Ventures, Aurora Funds, The Manufacturers Life Insurance Company and other venture capital and private financers, TissueInformatics has developed TissueAnalytics(TM) automated pathology software and services for more precise identification and quantification of tissue. Building upon TissueInformatics' expertise in automated pathology software for the quantitative analysis of animal tissue slides from drug safety studies, dermapathology, and correlative bioinformatics, TissueInformatics seeks to accelerate the drug discovery process by providing a broad range of tissue analysis software, tissue analysis services, and drug target discovery solutions to the pharmaceutical, biotechnology and CRO industries. For more information, visit www.TissueInformatics.com .<<

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Cheers, Tuck

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To: nigel bates who wrote (80)2/10/2004 4:20:46 PM
From: tuck
   of 101
 
PDGM's Alan J Higgins discusses systems biology, biomarkers, and metabolomics, with vague mention of their own process for incorporating these fields into their strategic plan. DCGN also mentioned . . .

currentdrugdiscovery.com

The good news? The human metabolome is pretty darn small -- though that doesn't mean its elucidation will be fast or easy.

Cheers, Tuck

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To: tuck who wrote (83)2/10/2004 5:02:17 PM
From: nigel bates
   of 101
 
Thanks for the link.

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To: tuck who started this subject3/22/2004 12:58:58 PM
From: tuck
   of 101
 
>>RESEARCH TRIANGLE PARK, N.C., March 22 /PRNewswire-FirstCall/ -- Paradigm Genetics, Inc. (Nasdaq: PDGM - News), a biotechnology company, today announced it will present results from metabolomics analyses undertaken as part of its biomarker research collaboration with the National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), at the 43rd Annual Meeting of the Society of Toxicology. The in-life studies were conducted under NIEHS Contract No. NO1-ES-65406 by Battelle for the study of acetaminophen toxicity in liver. The metabolomics data demonstrate that biochemical profiling is a powerful tool for generating biomarkers useful in monitoring and diagnosing liver injury, and will help to reveal the biochemical mechanisms involved in toxicity. Acetaminophen overdose remains the leading cause of hospital admissions for acute liver toxicity in the U.S.

The biomarker collaboration between Paradigm Genetics and the NIEHS to study the mechanism of acetaminophen toxicity in liver began in June 2003. The research is focused on identifying better diagnostics for assessing liver damage and individual patient response to therapeutic treatment.

"Currently, the diagnosis of liver damage, based on traditional serum markers, may not be early enough or reliable enough to make medical decisions in the absence of additional clinical testing. The challenge is to identify more sensitive biomarkers in serum and urine that signal liver function and the mechanisms underlying liver injury at an earlier time in the disease process, thereby allowing physicians to explore more and better treatment opportunities," said Tom Colatsky, Ph.D., Vice President, Healthcare Research for Paradigm Genetics. "Our research has shown that biochemical signals can provide these types of early, more sensitive indicators of liver injury and toxicity."

Separately, the company announced that it is co-sponsoring with Agilent Technologies a workshop titled "Advancing Toxicity Assessment through Microarray Gene Expression Analysis." The workshop, which is scheduled for Monday, March 22, at 3:45 p.m., will include discussions on visualizing chemical effects through gene expression, integration of traditional toxicology parameters with gene expression measurements, and pathways for neurotoxicity.

The relationship between Paradigm Genetics and the NIEHS also includes a five-year toxicogenomics contract for $23.8 million with the National Center for Toxicogenomics. The contract is focused on determining how toxicants work and cause damage at the cellular level. The research may result in better methods of risk assessment and compound optimization for both the pharmaceutical and chemical industries. In April 2003, the NIEHS exercised an option to the existing contract, providing for an additional $8.4 million for toxicogenomics studies for the National Toxicology Program.<<

snip

Cheers, Tuck

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To: tuck who started this subject4/22/2004 2:55:39 PM
From: nigel bates
   of 101
 
Paradigm Receives Second U.S. Patent for Fungicide Target Pathway

RESEARCH TRIANGLE PARK, N.C., April 22 /PRNewswire-FirstCall/ -- Paradigm Genetics, Inc. (Nasdaq: PDGM - News), a biotechnology company, today announced that the company has been issued U.S. Patent No. 6,723,529, titled "Methods for the Identification of Inhibitors of Alpha-Aminoadipate Reductase as Antibiotics." The patent covers the discovery of a novel gene target (Alpha-Aminoadipate Reductase) in the biochemical pathway by which fungi produce lysine, a nutrient necessary for the growth and development of fungi, as well as methods enabling the discovery of chemicals that inhibit gene protein activity within the lysine pathway. Chemical compounds discovered by Paradigm's patented method may lead to the development of more effective, less toxic fungicides, which are highly sought after throughout the agricultural industry.

"The issuance of this patent significantly strengthens our intellectual property position on important fungicide target pathways and further demonstrates our ability to apply a systems biology approach to gain a more comprehensive understanding of entire biological systems," Keith Davis, Ph.D., Vice President, Agricultural Research. "Our scientists were able to identify a second novel target within the lysine synthesis pathway. By inhibiting steps along this critical pathway, we can potentially prevent the growth of fungi known to harm commercial crop production. We believe this discovery will have significant commercial applications, as companies aggressively pursue the development of fungicides that are environmentally safe and more effective than existing products."

"This discovery supports our strategy of leveraging our technologies, intellectual property and expertise to begin developing our own product opportunities, while continuing to provide the highest quality research for our current and future partners," said Heinrich Gugger, Ph.D., President and CEO. "This patent, along with the other four fungicide discovery patents issued in the past year, represent the first fruit of our investment in this area and is the beginning of a pipeline of patents we expect to issue in the years to come. Our plan is to use this growing IP portfolio to develop proprietary fungicide products and to drive high value R&D collaborations with agrichemical companies."

Paradigm also announced the issuance of two additional fungicide discovery patents, bringing the company's total fungicide patent portfolio to five. One of the new patents (U.S. Patent No. 6,703,200) broadens the scope of Paradigm's proprietary TAG-KO® technology, a tool for the rapid and systematic mutation of pathogenic fungi, enabling the efficient identification of novel antifungal and fungicide targets as well as novel biosynthetic and degradation pathways. The second patent (U.S. Patent No. 6,689,578) protects a fungicide target in the heme production pathway. Paradigm Genetics has 19 U.S. issued patents in total.

About Paradigm Genetics

Paradigm Genetics is a biotechnology company using proprietary systems biology to discover biomarkers to reduce the cost, risk and time of product development, as well as to discover inaccessible targets for small molecule discovery, both for our partners and for Paradigm Genetics. Paradigm Genetics has major collaborations with the National Institute of Environmental Health Sciences, the National Institute of Standards & Technology's Advanced Technology Program, Bayer CropScience, the Monsanto Company, Pioneer Hi-Bred International Inc. and L'Oreal Inc. For more information,

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To: nigel bates who wrote (86)5/6/2004 11:29:19 AM
From: tuck
   of 101
 
>>RESEARCH TRIANGLE PARK, N.C., May 6 /PRNewswire-FirstCall/ -- Paradigm Genetics, Inc. (Nasdaq: PDGM - News), a biotechnology company, announced today that its current contract with the National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health, has been expanded to include additional work using small interfering ribonucleic acid (siRNA) technology as a part of the toxicogenomics research Paradigm Genetics is performing for the NIEHS. Paradigm Genetics is in the process of subcontracting with the Translational Genomics Research Institute (TGen), a non-profit biomedical research institute, to build a siRNA "library" for use in better understanding genes that appear to be involved in human response to environmental toxins. The Company noted that the NIEHS contract modification, which is expected to accelerate the timing of revenue generation under the contract option, is another step toward successfully reaching its 2004 revenue target.

"This contract amendment reflects the close and productive relationship between Paradigm Genetics and the NIEHS, as the National Center for Toxicogenomics works to build the Chemical Effects in Biological Systems (CEBS) database," said Thomas J. Colatsky, Ph.D., Vice President of Healthcare Research at Paradigm Genetics. "siRNA is a new and extremely powerful tool that can help characterize gene function. Using siRNA, genes suspected of playing a role in producing tissue injury can be knocked-out, thereby validating their involvement in toxic responses and gaining a richer understanding of toxicity mechanisms. We look forward to working with Dr. Jeff Trent, President of TGen, and Dr. Spyro Mousses, who heads up TGen's scientific team, to build this comprehensive, centralized siRNA resource for the NIEHS."

In 2000, the NIEHS initiated the National Center for Toxicogenomics (NCT), which seeks to better understand human responses to environmental exposures through the identification and characterization of the genes most critically associated with chemical-induced toxicity using gene expression technology. The NCT is currently conducting studies to determine the identity, expression and function of these "Tox Genes" and to evaluate their value in environmental safety assessment. siRNA provides a means of rapidly determining gene function and determining whether specific genes are, in fact, responsible for generating a toxic response.

Paradigm Genetics and the NIEHS began a toxicogenomics collaboration in September 2002. The five-year, $23.8 million contract is focused on how toxicants work and cause liver damage at the cellular level. The research may result in better methods of risk assessment and compound optimization for both the pharmaceutical and agrichemical industries. In April 2003, the NIEHS exercised an option in the existing contract, providing an additional $8.4 million for toxicogenomics studies. Data generated from this toxicogenomics research will be included in the NTP's program to better understand the effects of short and long-term exposure to chemicals. The data will become part of the Chemical Effects in Biological Systems (CEBS) database, a publicly accessible relational database that will contain information on the biological effects of short and long term exposures to chemicals.

About TGen

TGen's mission is to make and translate genomic discoveries into advances in human health. "Translational genomics research" is a relatively new field employing innovative advances arising from the Human Genome Project to apply to the development of diagnostics, prognostics and therapies in cancer, neurological disorders, diabetes and other complex diseases. For more information, visit www.tgen.org .<<

snip

Cheers, Tuck

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To: tuck who started this subject6/21/2004 9:48:55 AM
From: tuck
   of 101
 
>>RESEARCH TRIANGLE PARK, N.C., June 21 /PRNewswire-FirstCall/ -- Paradigm Genetics, Inc. (Nasdaq: PDGM - News), a biotechnology company, announced today that it has received a Small Business Innovation Research Phase I/II contract from the National Institute of Environmental Health Sciences, National Institutes of Health, entitled "Metabolomics and Pathway Linkage: Urine, Serum, and Liver." The Fast Track contract will support Paradigm's efforts to discover biochemicals in urine, serum and liver tissue that predict the early onset of drug-induced liver injury. "Fast Track" refers to a mechanism used by the NIH to expedite the decision and award of applications that have a high potential for commercialization.

Under the award, Paradigm will conduct preclinical studies on three compounds known to cause liver damage, using mass spectrometry to measure changes in hundreds of small molecular weight biochemicals that may be linked to liver toxicity. These findings could lead to the development of diagnostics that provide earlier, more reliable signals of liver injury and would help to screen more consistently for these effects in the drug development process. In addition, these types of diagnostics would have application in identifying those patients who respond adversely to certain treatments and may help physicians ensure that patients receive the most appropriate medications for particular diseases.

Thomas J. Colatsky, Ph.D., Vice President of Human Health Research at Paradigm Genetics, commented, "Currently, liver injury is not detected until the liver is severely damaged. Paradigm's objective through this study is to identify non-invasive biomarkers that are more sensitive predictors of the early onset of liver injury. These biomarkers may be useful as diagnostics that will help pharmaceutical companies to better assess drug candidate safety. This research represents an important part of our broader commitment to finding biomarkers for disease and drug action that will streamline drug trials, stratify patient populations and eventually enable physicians to more effectively diagnose and treat disease."

The importance of biomarkers has been highlighted by the Food and Drug Administration (FDA), which issued a March 2004 report outlining the importance of biomarkers in the drug development process for enhancing predictability and improving clinical trial efficiency. Paradigm's biomarker discovery program is focused on developing integrated suites of biomarkers that can be used to predict, diagnose and monitor drug and chemical-induced toxicity more reliably than currently used measurements. The Company's acquisition of TissueInformatics, Inc. provides Paradigm with well-validated technologies for obtaining quantitative tissue information for use in Paradigm's biomarker discovery efforts. This competitive advantage positions Paradigm at the forefront of biomarker discovery research.

The fast-track contract is worth up to $742,000, with $99,000 funded for the six-month Phase I part of the study and an additional $643,000 over two years for Phase II, upon the successful completion of Phase I. This project has been funded in whole or in part with Federal funds from the National Institute of Environmental Health Sciences, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN291200445524C.

In addition to the current study, Paradigm's liver toxicity research activities include a collaboration with the University of North Carolina at Chapel Hill to identify biomarkers indicative of choline deficiency, a physiological state that has been implicated in the onset of liver damage in humans. Also, the Company is working with UNC-CH, the National Institute of Environmental Health Science (NIEHS) and NIH to determine the underlying mechanisms by which acetaminophen causes liver toxicity.<<

snip

Cheers, Tuck

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To: tuck who started this subject6/23/2004 4:12:09 PM
From: tuck
   of 101
 
>>RESEARCH TRIANGLE PARK, N.C., June 23 /PRNewswire-FirstCall/ -- Paradigm Genetics, Inc. (Nasdaq: PDGM - News), a biotechnology company, announced today that it has received a second Fast Track Small Business Innovation Research Phase I/II contract from the National Institutes of Health (NIH), this one entitled "Metabolomics: Alcohol Induced Toxicity." The funding for this second contract supports the application of biochemical profiling to the discovery of biomarkers for alcohol-related diseases. "Fast Track" refers to a mechanism used by the NIH to expedite the decision and award of applications that have a high potential for commercialization.

The first phase, a six-month study that commences September 1, 2004, is funded by NIH's National Institute of Alcohol Abuse and Alcoholism, and will be undertaken in collaboration with the University of North Carolina at Chapel Hill. Phase I includes preclinical studies examining the acute and chronic effects of high doses of ethanol, an addictive toxin that is primarily processed by the liver. Using mass spectrometry, the Company will identify key biochemicals in liver, brain and plasma that are altered in association with changes in tissue pathology and other traditional measures of disease, such as elevated serum enzyme levels. The altered biochemicals will be mapped to their relevant biochemical pathways as a means of determining a mechanism and assessing a causal linkage to disease. Upon successful completion, the Phase I study will be extended into a Phase II study where the metabolomic assessment of plasma, liver and brain metabolites will also include the integrated analysis of gene expression.

"We are happy to see our pioneering work in the area of biochemical profiling and data integration acknowledged through this fast track award. This research should enable us to find better ways of diagnosing the diseases often attributable to alcohol abuse," said Thomas J. Colatsky, Ph.D., Vice President of Human Health Research at Paradigm Genetics. "Liver disease continues to be a major health problem, and is often difficult to diagnose until its later stages. This award will not only help in the continued building of our biomarker discovery program, but also in extending our relationship with the UNC-CH. We have been collaborating with UNC-CH in ongoing clinical studies on novel biomarkers for liver injury."

"I am excited that this collaboration with Paradigm Genetics will provide us with the opportunity to discover unique metabolic biomarkers that relate to and predict pathological changes induced by acute alcohol abuse and alcoholism in liver, brain and perhaps in other critical target organs," said Fulton T. Crews, Ph.D., Director, Bowles Center for Alcohol Studies, and UNC-CH Professor of Pharmacology and Psychiatry.

The fast track contract is worth up to approximately $850,000, with $100,000 funded for the six-month Phase I part of the study and up to $750,000 over two years for Phase II, upon the successful completion of Phase I. This project has been funded in whole or in part with federal funds from the National Institute of Alcohol Abuse and Alcoholism, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN281200410004C.<<

snip

PDGM keeps afloat on these little wins. Will it ever add up to a turnaround?

Cheers, Tuck

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