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   Biotech / MedicalParadigm Genetics -- PDGM

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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.<<


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

4 8/19/2005 6/1/2005 People
4 8/19/2005 6/1/2005 People
4 8/19/2005 6/1/2005 People
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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From: nigel bates1/12/2006 7:21:54 AM
   of 101
Clinical Data, Inc. Announces Collaborative Research Agreement with University of Pittsburgh Cancer Institute for Metabolomics Analysis of Lung Cancer Samples
Thursday January 12, 7:00 am ET

NEWTON, Mass.--(BUSINESS WIRE)--Jan. 12, 2006--Clinical Data, Inc. (NASDAQ: CLDA - News), a worldwide leader in developing and commercializing pharmacogenomics and clinical diagnostics, announced today that it has entered into a collaborative research agreement with the University of Pittsburgh Cancer Institute (UPCI). Under the agreement, Clinical Data, acting as the study sponsor, will apply metabolomics analysis to serum samples from a population of patients diagnosed with lung cancer and matched control subjects without lung cancer recruited as part of the National Cancer Institute (NCI)-funded Specialized Program of Research Excellence (SPORE) in Lung Cancer at the UPCI. The serum samples will be provided to Clinical Data by the UPCI.

Metabolomics is the science of comprehensively measuring and analyzing large numbers of biochemicals produced by the human body. These metabolites represent the end products of gene and protein expression. Their qualitative and quantitative analyses generate a biochemical phenotype of an organism. Metabolomics also offers the unbiased ability to differentiate organisms or cell and disease states based on metabolite levels that may or may not produce visible phenotypes and/or genotypes.

Israel M. Stein, MD, President and Chief Executive Officer of Clinical Data, said, "This is an important collaboration for Clinical Data and could generate new insight into the applicable pharmacogenomics of a diverse patient population afflicted with lung cancer. In essence, this collaboration supports a pilot study to determine the suitability of metabolomics for cancer detection and screening. We anticipate that the data created by this study may demonstrate the robustness of our metabolomics platform to both research partners and potential customers. The field of metabolomics offers tremendous promise for patients and the drug industry alike. We know that Clinical Data possesses one of the most robust metabolomics platforms and analytical skill sets in this industry. We anticipate that the results of this analysis may yield a strong case for commercialization within the lung cancer application."

This collaboration will pursue what the Company believes is the first metabolomics study in a lung cancer population. The Company notes that any new intellectual property or inventions that are derived from this study will remain the property of the respective party that makes any new discovery with final ownership determined by applicable U.S. Patent Law.

William L. Bigbee, PhD, will be the lead investigator for the University of Pittsburgh. Dr. Bigbee is a Professor in the Departments of Environmental & Occupational Health and Epidemiology in the University of Pittsburgh Graduate School of Public Health and also is Leader of the Molecular Biomarkers Group and a Member of the Cancer Epidemiology, Head and Neck Cancer, and Lung and Thoracic Malignancies Programs at the UPCI. In addition, Dr. Bigbee serves as Director of the Clinical Proteomics Core Facility at UPCI and Associate Director for Basic Research of the UPCI Lung Cancer SPORE, Principal Investigator, Jill M. Siegfried, PhD, who is also a co-investigator in the study. For Clinical Data, the study sponsor, Thomas Colatsky, PhD, Icoria's Chief Scientific Officer, will be the lead investigator in the collaboration. Both parties retain the rights to publish the results and disseminate information pertaining to the research conducted under this collaboration agreement.

About Clinical Data, Inc.

Clinical Data, Inc. is a worldwide leader in developing and commercializing pharmacogenomics and clinical diagnostics to improve patient care. The Company's genomic services are marketed to the pharmaceutical, biotech, clinical, academic and agricultural marketplaces. The Company is utilizing pharmacogenomics to develop molecular diagnostics and more efficacious therapeutics by finding genetic markers to guide drug development and utilization. Its diagnostic and instrumentation business has a market focus on the physician's office, hospital and small-to-medium sized laboratory segments.

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To: Mike McFarland who wrote (95)1/21/2006 11:50:28 AM
From: Mike McFarland
   of 101
CLDA "reorganizing into two operating divisions to be known
as Clinical Data Molecular and Vital Diagnostics. The
Clinical Data Molecular division will consolidate the
operations of Genaissance Pharmaceuticals, Inc., Lark
Technologies, Inc. and Icoria, Inc., all of which were
acquired by the Company during 2005. The Vital Diagnostics
division will consolidate the operations of Clinical Data
Sales and Service, Inc., Vital Scientific NV, Vital
Diagnostics Pty. Ltd., and Electa Lab s.r.l., the
Company’s previously owned subsidiaries in the small volume
clinical diagnostics market.

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To: Mike McFarland who wrote (97)1/24/2006 11:32:27 AM
From: Mike McFarland
   of 101
Clinical Data and IO Informatics
The $11.7-million grant was initially awarded to Clinical Data subsidiary Icoria in 2002

IO Informatics' intelligent multidimensional object
IMO will be applied to data accumulated through Clinical Data's Gene-to-Cell System

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To: Mike McFarland who wrote (97)1/26/2006 11:30:26 AM
From: nigel bates
   of 101
Clinical Data Initiates Pivotal Phase III Trial for Novel Antidepressant
Thursday January 26, 8:00 am ET
First Ever Pharmacogenomic Screening Tool for Antidepressant to be Developed Concurrently
Maybe should have posted to the defunct Genaissance thread ?
Though this one seems more active...

NEWTON, Mass.--(BUSINESS WIRE)--Jan. 26, 2006--Clinical Data, Inc. (NASDAQ: CLDA - News), a worldwide leader in commercializing pharmacogenomics to guide drug utilization, announced today that the Company will begin enrollment of a pivotal Phase III clinical trial for vilazodone, a novel compound being studied for treatment of depression, and anticipates having initial results from this study available by mid-2007. The successful outcome of this trial would serve as one of two pivotal trials required for a new drug application ("NDA"), which the Company hopes to file with the United States Food & Drug Administration as early as year end 2008.

Carol R. Reed, M.D., the Company's Chief Medical Officer, said, "Following our recent meeting with the staff of the Division of Psychiatry Products of the FDA we are accelerating our development plans for vilazodone and a companion biomarker test. We believe this program has the potential to revolutionize the treatment of depression. As part of this trial, Clinical Data will use its expertise in biomarker discovery to identify biomarkers for response to vilazodone. We plan to use these biomarkers to develop a test to screen for patients who are likely to benefit from the drug. About half of depressed patients do not achieve satisfactory results with current first-line treatment options; we hope to assist physicians in matching a patient with a treatment that is likely to work for that patient. There are no such predictive tests currently available."

"This is a transformative event in the history of Clinical Data," said Clinical Data's President and CEO, Israel M. Stein, M.D. "The development of a genetic-based, predictive screening tool to guide the use of a novel antidepressant would represent a significant advance in pharmacogenomics and in the treatment of depression. While available therapeutics are many, a patient's response is highly individualized, leading to trial-and-error inefficiencies and unnecessary delay in finding effective treatment."

About Vilazodone

Vilazodone is a novel, dual serotonergic antidepressant. It is both a Selective Serotonin Reuptake Inhibitor (SSRI) and a 5HT1A partial agonist. The compound has been assessed in 15 phase I and five phase II trials involving a total of 369 healthy subjects and 1163 depressed patients. Vilazodone has been found to have an acceptable safety profile for this stage of development. In previous trials with positive controls, vilazodone failed to demonstrate significant efficacy against placebo but demonstrated efficacy comparable to that of the positive control, an approved antidepressant in wide use. The rights to develop and commercialize vilazodone were acquired from Merck KGaA of Darmstadt, Germany, in September 2004.

Clinical Trial Design

This double-blind, placebo-controlled clinical trial is designed to assess the efficacy and safety of vilazodone and to discover genetic markers of treatment response associated with vilazodone. The trial will enroll approximately 400 adult patients diagnosed with Major Depressive Disorder at eight US centers. Potential biomarkers will be examined for each clinical subject, and the genetic analysis will be performed in-house by the company at its GLP- and CLIA-approved facilities, which perform similar genetic services for many major pharmaceutical companies. At least one long-term safety study, which has yet to be reviewed by the FDA, will be required prior to NDA filing. The Company is hopeful that clinical subjects from each of the pivotal efficacy trials will participate in the long-term safety studies.

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