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DNA Repair, Helsinki Hospital, Ferrer, Agendia, Power3, Jordan University, Lundbeck, Cogenics, Vermillion, ThinkPanmure, TheraGenetics, Centre for Addiction and Mental Health, Merck, Pfizer, Eli Lilly, PureTech Ventures, Enlight Biosciences, Iverson, DNA

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DNA Repair Licenses Predictive Breast Cancer Therapy Test from Helsinki Hospital
 
The DNA Repair Company has licensed the exclusive North American rights to a test from Helsinki University Central Hospital that predicts how women with breast cancer will respond to a common chemotherapy drug.
 
The Boston-based company acquired the rights to the test through an agreement with Licentia, a Finnish technology transfer company. DNAR plans to use a variant of the NQO1 enzyme to create personalized medicine tests.
 
The NQO1 enzyme was shown in a Helsinki University study to protect cells against oxidative stress, the company said, and patients having one variant of the protein, NQO1*2, had worse survival chances when they were treated with an anthracycline-based chemotherapy compared with an alternative therapy.
 
Women in the study who possessed a double copy of the NQO1*2 variant in their genome had only a 17 percent survival rate while those with only a single copy or without the variant had a survival rate of 75 percent.
 
This was the only study so far to discover this effect, the company said, and independent studies must be conducted in order to develop a test.
 
DNAR CEO Daniel Paterson said the findings about the NQO1*2 variant are “highly significant and hold important promise for predicting clinical outcomes for cancer patients.”
 
Financial terms of the agreement were not released.
 

 
Ferrer to Sell Agendia's Cancer Dx Services
 
Ferrer inCode, the biotech subsidiary of Spanish firm Grupo Ferrer, has gained exclusive rights to sell two of Agendia’s cancer diagnostic services in certain European countries, the firms said this week.
 
Ferrer will offer Agendia’s MammaPrint and CupPrint tests in Germany, France, Italy, and Portugal. Ferrer already sells the tests in Spain under an agreement signed last year.
 
MammaPrint is a prognostic, gene expression profiling test that uses a 70-gene signature to indicate the risk of breast cancer tumor recurrence. CupPrint is a gene expression profiling service that is used to identify the primary tumor site in cancers of unknown origin.
 
The firms said that they are discussing a potentially expanded deal to include other parts of the world.
 

 
Power3 Working with Jordan University to Validate Breast Cancer Dx
 
Proteomic diagnostics company Power3 Medical Products is collaborating with the Princess Haya Biotechnology Center at the Jordan University of Science and Technology for a clinical validation study of the company’s BC-SeraPro Breast Cancer diagnostic blood test.
 
Under the program, the Princess Haya center and Jordan University will provide breast cancer, benign breast disease, and age-matched control patient samples that the company will analyze using its panel of protein biomarkers.
 
Power3 said it plans to finish the clinical validation study in the third quarter of this year and to launch the BC-SeraPro in the first quarter of 2009. The company said it aims to develop a protein biomarker-based diagnostic test that can be applied “regardless of a woman’s genetic makeup or ethnicity.”
 
Among women in Jordan, breast cancer is the leading form of cancer and the second leading cause of death.
 
Power3 also is involved in clinical evaluation studies for its NuroPro blood-based test for Parkinson’s disease with the University of Thessaly Medical School in Greece and with the Cleo Roberts Center for Clinical Research at the Sun Health Research Institute in Sun City, Arizona.
 
The company also said it expects to introduce the NuroPro diagnostic for Parkinson’s and Alzheimer’s diseases in international markets later this year and in the US soon afterward.
 

 
Lundbeck to Use Cogenics' Genotyping Platform in Phase I Trials
 
Cogenics said this week that it will provide the Danish pharmaceutical company H. Lundbeck with genotyping services to support clinical drug studies.
 
Under the agreement, the Clinical Data subsidiary will conduct genotyping in its labs in Morrisville, NC, and in Bernried, Germany, for Lundbeck’s Phase I clinical trials. Cogenics said the period of the agreement is open-ended and that the companies plan to collaborate on other projects in the future.
 
Lundbeck is focused on developing and marketing drugs for treating psychiatric and neurological disorders.
 
Financial terms of the agreement were not released.
 

 
Vermillion Retains Investment Bank to Evaluate 'Strategic Alternatives'
 
Vermillion said this week that it has tapped investment bank ThinkPanmure to help it identify and evaluate “strategic alternatives” for maximizing shareholder value.
 
Vermillion said it plans to work with ThinkPanmure on ways to “enhance the potential” of its OVA1 and VASCLIR proteomic tests and its pipeline of proprietary biomarkers, but added that “no assurances can be given that this evaluation will lead to any specific action or transaction.”
 
The company did not disclose further details on the strategic alternatives it is considering.
 
Vermillion in late June filed for clearance from the US Food and Drug Administration for its OVA1 ovarian tumor triage test.
 
In May, it began a clinical study to support clearance of its VASCLIR test for peripheral arterial disease.
 

 
TheraGenetics Licenses IP from CAMH to Predict Response to Antidepressants
 
Pharmacogenetic diagnostic developer TheraGenetics said last week that it has licensed intellectual property from the Centre for Addiction and Mental Health in Ontario, Canada, related to predicting patient response to antidepressants.
 
TheraGenetics, which is developing a suite of tests to guide the treatment of central nervous system disorders, said that the kits will help determine whether certain patients are susceptible to side effects from antidepressants.
 
The company did not disclose further details of the IP that it licensed or the specific antidepressants that it plans to target with the tests.
 
Richard Kivel, CEO of TheraGenetics, said in a statement that the IP “further augments our capabilities to innovate pharmacogenetic diagnostics tests in a broad range of disorders, including schizophrenia, depression, bipolar disorder, Alzheimer's disease, and ADHD."
 

 
Merck, Pfizer, Lilly Form New Company to Speed Development of Drug-Discovery Tools
 
Merck & Co., Pfizer, and Eli Lilly said last week that they have partnered with PureTech Ventures to create a new firm called Enlight Biosciences that will focus on the development of new drug discovery technologies.
 
The three pharmas and PureTech have ponied up a total of $39 million that Enlight will direct toward “breakthrough technologies that can fundamentally alter drug discovery and development.”
 
Enlight is focused on “pre-competitive” technology that will “connect preclinical research, clinical development, and medical practice,” according to a company statement.
 
The company noted that despite the recent emergence of “vital enabling technologies” such as PCR, PET, RNAi, and gene microarrays, “over the last few years most traditional life science investors have focused their funding on late-stage therapeutic programs.”
 
As a result, Enlight said, “important technologies that could be of great strategic impact to the pharmaceutical industry are not being commercialized.”
 
Enlight said it has already begun technology development programs in the areas of molecular imaging, biologics, and drug delivery, and is planning to launch programs in other areas.
 
The company’s website lists a range of “areas of interest” under the categories of imaging and biomarkers, safety and toxicology, predictive models, chemistry and biochemistry, synthesis and production, formulation and delivery, and biologic platforms.
 
In the “biomarker” category, for example, Enlight is interested in developing “systems biology/multi-marker patterns, protein/antibody arrays, label-free binding assay methods, [and] platforms for patient segmentation.”
 
Rod MacKenzie, senior vice president of Pfizer Global R&D, said in a statement that the effort should help develop “breakthrough technologies” that will enable innovation in biopharmaceutical science, which he described as “an urgent priority” for drug-makers.
 

 
DNA Direct to Provide Personalized Reports for Iverson's Warfarin Sensitivity Test
 
DNA Direct and Iverson Genetic Diagnostics said last week that they are collaborating to provide personalized reports for customers of Iverson's warfarin-sensitivity assay.
 
Under the terms of the agreement, DNA Direct will provide a customized, web-based report for Iverson customers that will explain their test results in a “patient-friendly, interactive format,” the companies said.
 
The reports will be “personalized to the patient's test results,” the companies said, and will explain the implications for both general drug response and warfarin dosing, as well as how genes affect drug response, what factors impact dosing of the blood thinner, and what next steps may be most appropriate.
 
Patients will be able to download a copy of their lab report, as well as a clinical summary letter that they can share with their physicians.
 
Iverson’s Warfarin Dosing Panel XP identifies seven different variations of the CYP2C9 gene and nine different variations of the VKORC1 gene that play a role in determining response to warfarin.
 

 
Exact Sciences To Perform Clinical Study for CRC Assay, Expects to File 510(k) in 2009
 
Exact Sciences said last week that it is beginning a clinical study for its DNA-based colorectal cancer screening test that should take six to nine months, and that it plans to file for 510(k) approval for the test with the US Food and Drug Administration by the third quarter of 2009.
 
The company noted that it had completed discussions with the FDA regarding the clinical performance characteristics that will be required to validate its stool-based CRC assay and decided to “bolster the statistical power of the clinical study” by collecting “more clinical samples than the threshold that the FDA indicated would be acceptable.”
 
In October, the FDA warned the firm that its PreGen-Plus assay is a medical device that requires premarket approval. The company has been in discussions with the agency regarding the test since that time. 
 
Exact said that the clinical study could take up to nine months, which would enable a de novo 510(k) filing in the third quarter of 2009, and potential clearance of the test in the first quarter of 2010.
 
The prospective, multi-center study is expected to include around 30 participating sites in the US and Canada and will screen up to 5,000 asymptomatic individuals aged 50 or older who are at average risk for developing colorectal cancer. This study population is expected to yield a “minimum of 25 acceptable CRC cases,” Exact said.
 
The company said that the study will “exceed the FDA's minimum sensitivity performance threshold of a 95 percent confidence interval with a lower bound of 50 percent.”
 
Averion International, a clinical research organization, will manage the study.
 
The company said it expects the total study and regulatory costs to range from $6.5 million to $8.5 million. It added that its current cash and short-term investments will provide around $2 million through the end of 2008 to begin the validation studies.
 
In March, Exact said it was seeking “strategic alternatives,” which could include merging with or being bought by another company, and that it had retained investment banking firm Leerink Swan to help it evaluate opportunities.

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