|Vertex Announces Positive Results from ALS-2200; XOMA, Oncobiologic Agree on Collaboration Agreement|
|By Staff and Wire Reports|
|Monday, 30 July 2012 18:19|
Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) and its collaborator Alios BioPharma, Inc. announced positive results from a viral kinetic study of the nucleotide analogue ALS-2200 for the treatment of hepatitis C. There was a median 4.54 log10 reduction in hepatitis C virus (HCV) RNA in people with genotype 1 chronic hepatitis C who were new to treatment (n=8) after seven days of dosing with 200 mg of ALS-2200 once daily. ALS-2200 was well-tolerated in this study, and no patients discontinued due to adverse events. Based on these data, Vertex plans to begin Phase 2 studies this year of 12-week all-oral regimens including ALS-2200 in people with genotype 1 hepatitis C, pending discussions with regulatory agencies.
Patients with hepatitis C dosed with ALS-2200 in this study had a dose-dependent, consistent and rapid decline in HCV RNA. After three days of dosing, a median 3.85 log10 decline was observed among patients in the 200 mg dose group. In this dose group, a median 4.54 log10 decline was observed after seven days of dosing, which was maintained for up to two days after the completion of dosing. Four of eight patients in this dose group achieved HCV RNA levels below the limit of quantification (<LOQ = < 25 IU/mL). There were no serious adverse events observed in people dosed with ALS-2200 in the study. Data from this study have been submitted to a medical meeting for presentation in the second half of this year.
Based on these data, Vertex expects to conduct a study to evaluate ALS-2200 in combination with INCIVEK® (telaprevir), the companys approved protease inhibitor for people with genotype 1 hepatitis C, and a study of ALS-2200 in combination with ribavirin. These studies will evaluate 12 total weeks of treatment with a primary endpoint of SVR12 (sustained viral response: undetectable hepatitis C virus 12 weeks after the end of treatment) in people with genotype 1 hepatitis C.
Were encouraged by the substantial, rapid and consistent viral decline and initial safety results from this study, which make ALS-2200 a very promising part of Vertexs hepatitis C pipeline, said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer at Vertex. ALS-2200, with its high level of antiviral activity, gives us flexibility to explore several combinations of all-oral treatment regimens for hepatitis C. Were moving quickly to begin the first Phase 2 trials this year.
Oncobiologics announced a collaboration agreement with XOMA (NASDAQ:XOMA) Corporation to develop novel biotherapeutics based on engineering single-chain variable fragments into a bi-specific antibody scaffold. Through the partnership, Oncobiologics will utilize XOMA's ADAPT fully human antibody technology platform as a key component of its drug discovery program.
Under the agreement, Oncobiologics will gain access to XOMA's highly diverse library of scFv antibodies and associated patent estate, and will utilize XOMA's know-how and proven software tools as it advances its own candidates for treating cancer and immune diseases. Financial terms were not disclosed.
Accuray Incorporated (Nasdaq: ARAY), the premier radiation oncology company, announced today that more than 70 studies on the clinical use of the CyberKnife Robotic Radiosurgery® System and the TomoTherapy® System will be presented at the 54th Annual Meeting of the American Association of Physicists in Medicine (AAPM) taking place in Charlotte, N.C.July 29 - August 2, 2012.
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OncoSec Medical Inc. (OTCBB:ONCS), which is developing its advanced-stage OMS ElectroOncology therapies to treat solid tumor cancers, announced it has received notified body certification to the International Organization for Standardization's (ISO) 13485 standard for the "design, development, manufacture, and distribution of electroporation devices."
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Pharmos Corporation (OTCQB: PARS) today reported financial results for the second quarter and six-month period ended June 30, 2012.
Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today it will transition six more products of its pediatric vaccine portfolio to two-dimensional (2D) barcoding technology by the beginning of 2013.
Verenium Corporation (Nasdaq: VRNM), a leading industrial biotechnology company focused on the development and commercialization of high-performance enzymes,today announced that it will release 2012 second quarter financial results on Monday, August 6, 2012 after market close.