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   Biotech / MedicalParadigm Genetics -- PDGM


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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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To: tuck who started this subject6/28/2004 9:31:16 AM
From: tuck
   of 101
 
>>RESEARCH TRIANGLE PARK, N.C., June 28 /PRNewswire-FirstCall/ -- Paradigm Genetics, Inc. (Nasdaq: PDGM - News), a biotechnology company, announced today that the National Institute of Environmental Health Sciences (NIEHS) has agreed to expand its current research relationship with Paradigm Genetics to now include a study of four to six additional known liver toxicants and the integrated analysis of gene expression, metabolic profiles and quantitative tissue feature data. Results from the broadened study will generate a preliminary data set for a research version of the Chemical Effects in Biological Systems (CEBS) Database at NIEHS' National Center for Toxicogenomics (NCT). CEBS will be a publicly accessible toxicology reference database that will contain information on the biological effects of chemicals and other agents and their mechanisms of action. The new agreement builds on the current collaboration between Paradigm Genetics and NIEHS on acetaminophen toxicity.

The additional gene expression analysis for this larger group of liver toxicants will be performed by Paradigm Genetics under the Company's existing contract with NIEHS and is expected to accelerate the timing of revenue generation under this contract. The expansion of the research relationship allows additional toxicants to be tested, as well as the generation of metabolic profiles and quantitative tissue feature data, which can then be analyzed in conjunction with gene expression data. Accordingly, under the expanded agreement, Paradigm Genetics and NCT will be applying a systems biology approach to the study of toxicity by evaluating liver samples provided through studies funded by NCT.

"The NCT continues to work towards fulfilling its mission of coordinating a nationwide research effort for the development of a toxicogenomics knowledge base," said Raymond W. Tennant, Ph.D., Director, National Center for Toxicogenomics. "Paradigm Genetics' ability to integrate gene expression with metabolic changes in biological pathways, and the automated quantitation of tissue injury will help us fulfill this mission."

"We are pleased that the NIEHS and NCT continue to look to us for the best possible biological information on mechanisms of toxicity," said Heiri Gugger, Ph.D., President and CEO of Paradigm Genetics. "This expanded research relationship -- which involves the concurrent analysis of multiple types of biological data -- underlines Paradigm's leadership role in systems biology as applied to such relevant fields as toxicity and liver disease."

In 2002, Paradigm was awarded a five-year toxicogenomics contract of up to $23.8 million by the NIEHS. The contract was focused on determining how toxicants work and cause damage at the cellular level. In 2003, the NIEHS exercised an option providing for additional funding of $8.4 million for toxicogenomics studies. Portions of this newly broadened research effort will be funded from the contract option that was exercised in 2003.

Paradigm Genetics is focused on the discovery and development of diagnostics for liver injury and chronic liver disease. Its research activities include a clinical collaboration with the University of North Carolina at Chapel Hill (UNC-CH) to identify biomarkers associated with liver damage secondary to dietary choline deficiency. The Company is also working with UNC-CH to determine the mechanisms by which acetaminophen causes liver toxicity in humans.<<

snip

Cheers, Tuck

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To: tuck who wrote (90)8/16/2005 11:26:06 AM
From: Mike McFarland
   of 101
 
Icor.ob earnings:

From the PR

As of June 30, 2005, Icoria reported unrestricted cash, cash equivalents and short-term investments in the amount of $8.7 million, down from $9.6 million as of December 31, 2004. In addition, as of June 30, 2005, the company's assets included accounts receivable of $4.6 million. A large portion of this receivable balance related to several invoices from the NIEHS contract which are expected to be collected in the third quarter of 2005.

From the 10q

1. We recognize revenues relating to our partnership with NIEHS on a cost plus fixed fee basis, generally as samples are processed. In the first quarter of 2005, revenues increased primarily as a result of a higher number of samples processed. The Company expects this sample volume to continue in 2005 and, as a result, we expect revenues will increase in 2005 when compared to 2004.

2. We recognize revenues relating to our service business, Paradigm Array Labs™ , as we complete work for its various customers. Revenue during the second quarter of 2005 decreased compared to the same period in 2004 primarily due fewer samples being processed.

3. We recognize revenues under our grants as the related expenses are incurred. Grant revenues for the three months ended June 30, 2005 and 2004 were generated from the ATP grant. Revenue during the second quarter of 2005 increased compared to the same period in 2004 due to a change in our grant partner which temporarily delayed performance on the grant for a brief period in 2004.

4. The final revenue related to the Bayer contract was recognized during the three months ended March 31, 2005.

5. We recognize revenues relating to our partnership with Monsanto by comparing the number of genes analyzed during the period to the total number of genes to be analyzed over the term of the contract. Revenues related to this commercial partnership ended during the second quarter of 2005 as a result of the Monsanto transaction occurring in March 2005 and all assets transitioning to Monsanto in May 2005.

6 We recognize revenue on the Monsanto transition services agreement as services are delivered. This agreement began in May 2005.

7. We recognize revenues relating to our partnership with DuPont- Pioneer Hi-Bred by comparing the number of plant lines analyzed during the period to the total number of plant lines to be analyzed over the term of the three-year contract. This commercial partnership was signed in December 2003 and performance began during the first quarter of 2004.

8 We recognize revenues relating to our partnership with DuPont by comparing the number of traits analyzed during the period to the total number of traits to be analyzed over the term of the one year contract. This commercial partnership was signed in early 2005 and began to make significant progress during the second quarter of 2005.

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To: Mike McFarland who wrote (91)8/25/2005 1:06:38 AM
From: Mike McFarland
   of 101
 
Something like 350k shares yesterday, I know
that is only $60k, but caught my eye.

Also, insiders who left the company have
let go of some of their shares. For instance,
Gugger sold 97k shares at 27 cents, and
still held 200k shares as of June 1st.
etc etc

Rpt Per : COLATSKY THOMAS J
4 8/19/2005 6/1/2005 People
ICORIA, INC. Rpt Per : GUGGER HEINRICH
4 8/19/2005 6/1/2005 People
ICORIA, INC. Rpt Per : BUZOGANY J BARRY
4 8/19/2005 6/1/2005 People
ICORIA, INC. Rpt Per : FARABAUGH BRETT
4 8/19/2005 6/1/2005

Also, Icoria issued yesterday this PR:
...signed an agreement with Isis Pharmaceuticals to
identify biomarkers of toxicity in animal models. Icoria will
use its metabolomics platform to characterize differences in
biochemical profiles between treated and untreated animal
subjects and to identify those biochemicals that are
specifically affected by treatment. Isis can use this
information to suggest pathways that may be altered by future
drug candidates.

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To: Mike McFarland who wrote (92)9/20/2005 10:44:01 AM
From: Mike McFarland
   of 101
 
Icoria shareholders will get 0.0139 share of Clinical Data common stock for each share of Icoria, the companies said in a statement.

Based on Clinical Data's closing price on Friday, the terms represent a price for Icoria of 32 cents per share, the companies said.

Shares of Icoria closed at 18 cents on Monday in over-the-counter bulletin board trade.

Clinical Data said Icoria's biomarker discovery platform is an excellent fit with its molecualr diagnostics business model.

Based on the current share price of Clinical Data and including the impact of the expected acquisition of Genaissance Pharmaceuticals Inc. (GNSC.O: Quote, Profile, Research) , Icoria shareholders will own about 7.6 percent of the combined company, the companies said.

The acquisition is expected to close late this year or in early 2006, pending approval by Icoria shareholders. (Reporting by Tuhin Kar in Bangalore)

------------------------------------
Boy, that was a little hairy--I owned it at 17.5
cents and for several weeks was underwater.
Current price seems a perfectly good price to
give the shares up, considering gnsc at first
glance looks somewhat broke. I bought some dpii
with the proceeds, fwiw.

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To: Mike McFarland who wrote (93)12/20/2005 4:21:20 PM
From: Mike McFarland
   of 101
 
Final numbers

Clinical Data will issue 0.01552 of its own shares for each
outstanding share of Icoria common stock, representing a
price of $.28 per Icoria share based on Clinical Data's share
price in mid-afternoon trading. The total value of the
transaction is approximately $11 million.

Is there a CLDA thread?

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To: Mike McFarland who wrote (94)1/4/2006 12:11:32 PM
From: Mike McFarland
   of 101
 
CLDA shares are up to $20 from around
$17.5 in the last several hours of trading,
including yesterday.

Clinical Data showed net assets
of only 14M, but they are very
marginally profitable, at least
before buying Icoria.

I'll put it on my watch list and try to
post any interesting headlines I see
here on the pdgm/icor thread. I see this
too, a very small deal:

acquired Electa Lab s.r.l. in a cash transaction valued at approximately $1.8 million. Electa Lab, headquartered in Forli, Italy, is a leading worldwide supplier of Erythrocyte Sedimentation Rate ("ESR") instrumentation and related consumables, with annual sales of more than $3 million. Electa Lab has also developed proprietary technology for the safe decapping of blood collection tubes and is developing instruments and assays for the immunochemistry and coagulation markets. The acquisition will be accounted for as a purchase and is expected to be immediately accretive to Clinical Data's earnings.

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