BioHouston http://www.biohouston.org/en/rss BioHouston RSS Feed. BioHouston http://www.biohouston.org/tresources/en/images/icons/tendenci34x15.gif http://www.biohouston.org Copyright 2008 BioHouston Tendenci Association Software by Schipul - The Web Marketing Company en-us noemail@biohouston.org Thu, 21 Aug 2008 18:25:15 GMT Release http://www.biohouston.org/en/rel/?129 Repros Therapeutics Inc. (NasdaqGM:RPRX) today announced that based on the robust efficacy demonstrated by Proellex® in the interim assessment of the Company’s Phase II endometriosis study, there are sufficient patients currently enrolled to provide for adequate power calculations for the Phase III endometriosis trials. Because of the profound effect noted in this interim analysis, the Company has decided to curtail further patient recruitment for the study. Based on this decision, greater than 40 patients will complete the four month study before yearend. The Company plans to request an end of Phase II meeting with the FDA before yearend and subsequently to commence the Phase III pivotal studies for Proellex in the treatment of endometriosis in the first half of 2009. An interim analysis was completed and reported for the Proellex Phase II US study at the Company’s analyst day held in New York on July 24th, 2008. The interim results, based on the data of approximately seven... http://www.biohouston.org/en/rel/?129 noemail@biohouston.org Mon, 18 Aug 2008 20:00:00 GMT Release http://www.biohouston.org/en/rel/?127 ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP) and Milestone Biosciences, LLC (Milestone) today announced the signing of a definitive license agreement under which Milestone will market Access proprietary product MuGard(TM) in the United States and Canada. Milestone is a company recently started by former executives and sales representatives of companies with an established commercial presence in oncology, including MGI Pharma, Amgen and Genentech. MuGard is used for the management of oral mucositis, a debilitating side effect of many anticancer chemotherapy and radiation treatments, and has already received marketing allowance from the U.S. Food and Drug Administration. Under the terms of the agreement, Milestone will pay Access upfront license fees and subsequent milestone payments that total $10 million along with a double digit royalty upon commercialization of MuGard. Milestone expects to launch MuGard in the US early in the first quarter of 2009. We... http://www.biohouston.org/en/rel/?127 noemail@biohouston.org Mon, 18 Aug 2008 20:00:00 GMT Release http://www.biohouston.org/en/rel/?119 Introgen Therapeutics, Inc. (NASDAQ:INGN), a developer of targeted molecular therapies for cancer, and its subsidiary Gendux Molecular Limited, today announced that the European Medicines Agency (EMEA) has accepted for review the companys Marketing Authrorization Application (MAA) for ADVEXIN(R) (p53 tumor suppressor therapy) for the treatment of recurrent, refractory squamous cell carcinoma of the head and neck. ADVEXIN is an innovative gene therapy designed to restore p53 tumor suppression that is blocked in the majority of tumors. If approved, ADVEXIN will be the first gene therapy product approved for use in Europe. Introgen and Genedux announced the submission of the ADVEXIN MAA on June 30, 2008. This acceptance of the ADVEXIN MAA by the EMEA marks an historic point in the growth of personalized medicine and the treatment of head and neck cancer, said Max Talbott, Ph.D., Introgens senior vice president of worldwide commercial development. This action by the EMEA underscores the... http://www.biohouston.org/en/rel/?119 noemail@biohouston.org Mon, 18 Aug 2008 17:00:00 GMT Release http://www.biohouston.org/en/rel/?128 Power3 Medical Products, Inc. (OTCBB:PWRM - News), a leading proteomics company specializing in the development and commercialization of diagnostic tests for early detection of breast cancer and neurodegenerative diseases, is providing an interim status report of its international validation study of the company’s NuroPro® blood serum biomarker test for Alzheimer’s disease. Power3 is currently conducting a 300-patient clinical validation study of its NuroPro® blood serum test for Alzheimer’s and Parkinson’s disease in collaboration with Dr. Marwan Sabbagh, the Director of Clinical Research at the Cleo Roberts Center of Clinical Research at the Sun Health Research Institute in Sun City, Arizona. The preliminary results of the Power3’s study look very promising. Clinicians around the world look forward to adding a tool to diagnose and treat Alzheimer’s earlier and therefore give the best care to their patients, says Dr. Sabbagh. To date, 92 Alzheimer and Control patient... http://www.biohouston.org/en/rel/?128 noemail@biohouston.org Wed, 13 Aug 2008 20:00:00 GMT Release http://www.biohouston.org/en/rel/?123 Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company developing novel cell therapies for multiple sclerosis, today announced the completion of a private placement financing with total gross proceeds of approximately $3.0 million. Opexa will use the proceeds from the financing to support the ongoing clinical development of Tovaxin, the company’s novel treatment for multiple sclerosis. Top-line data from the company’s Tovaxin Phase IIb clinical trial (TERMS) are expected to be presented in September 2008. New institutional investors Lehman Brothers and Diker Management, LLC joined existing shareholders, directors and officers to complete the financing. The financial support of new institutional investors, as well as our current investors and board, in advance of the results from our Tovaxin Phase IIb clinical study demonstrates an important vote of confidence for Opexa, said Neil K. Warma, president and chief executive officer of Opexa. Under the terms of the financing, Opexa received... http://www.biohouston.org/en/rel/?123 noemail@biohouston.org Wed, 13 Aug 2008 18:00:00 GMT Release http://www.biohouston.org/en/rel/?118 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, announced today that it has initiated formal preclinical development of LX7101, a new drug candidate for glaucoma. LX7101 is a small molecule compound that may have application in treating glaucoma by lowering fluid pressure in the eye through a new mechanism of action. Glaucoma is a disease of the eye which gradually impairs vision and is a leading cause of blindness in the United States. Upon successful completion of preclinical development, Lexicon plans to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for LX7101. Drugs currently on the market for glaucoma lower intraocular pressure by either reducing aqueous humor production or by increasing the passive outflow of fluid from the anterior chamber of the eye. Lexicon’s drug candidate, LX7101, reduces intraocular pressure by... http://www.biohouston.org/en/rel/?118 noemail@biohouston.org Wed, 13 Aug 2008 17:00:00 GMT Release http://www.biohouston.org/en/rel/?126 To protect potential patients from being unwitting victims in the proliferation of less than competent therapeutics, the Repair Stem Cell Institute LLC (RSCI) (http://www.RepairStemCells.org) and its Scientific Advisory Board (SAB) today announced the establishment of the industrys first standards of excellence for Repair Stem Cells(TM) (RSC) treatment centers worldwide who are using RSC, also known as Adult Stem Cells. Among the critical ethical criteria, which are required for facilities to be qualified for the RSCIs list of top treatment centers, are licensing and certification of the treating doctors by their countrys medical professional regulatory board. According to Don Margolis (don@repairstemcells.org; 214-556-6377), founder and chairman of the RSCI, Regrettably, there is a wave of offshore commercially available less-than-competent stem cell therapeutic practitioners. Their bogus, unwanted extravagant claims, which tout the potential of their stem cell... http://www.biohouston.org/en/rel/?126 noemail@biohouston.org Tue, 12 Aug 2008 20:00:00 GMT Release http://www.biohouston.org/en/rel/?125 OncoVista Innovative Therapies Inc. (OTC BB: OVIT.OB), a biopharmaceutical company engaged in the development and commercialization of targeted cancer therapies and diagnostics, announced today that Status Equity Research has initiated research coverage on the Company with a rating of Accumulate and a 36 month price target of $16 per share. The research report can be accessed at www.statusequity.com on the Status Research tab. st1:*{behavior:url(#ieooui) } About Status Equity Research: Status Equity Research is a monthly publication committed to providing coverage on unique emerging growth companies that can become sector leaders in the U.S. equity markets. Status Equity Research also provides market commentary, perspectives on geopolitical affairs and global economic issues. Status Equity Research’s core desired goal is to provide well rounded access to emerging growth companies that currently have limited visibility, yet possess significant prospects for growth. About... http://www.biohouston.org/en/rel/?125 noemail@biohouston.org Tue, 12 Aug 2008 18:00:00 GMT Release http://www.biohouston.org/en/rel/?120 Introgen Therapeutics, Inc. (NASDAQ:INGN), a developer of targeted molecular therapies for cancer, today announced the appointment of James E. Rothman, Ph.D., to the Companys board of directors. In September 2008, Dr. Rothman will relocate his laboratory from Columbia University to Yale University where he will serve as the Wallace professor of biomedical sciences, chairman of the Department of Cell Biology and founder of the Yale University Center for High-Throughput Cell Biology. Dr. Rothman is renowned for discovering the molecular machinery responsible for transfer of materials among compartments within cells. Understanding this delivery process, known as membrane fusion, is valuable for drug development since alterations in these pathways are important in cancer, diabetes, and diseases of the central nervous system. Through his work, Dr. Rothman has provided a unified conceptual framework for understanding such diverse and important processes as the release of insulin into the... http://www.biohouston.org/en/rel/?120 noemail@biohouston.org Tue, 12 Aug 2008 18:00:00 GMT Release http://www.biohouston.org/en/rel/?130 Caris Diagnostics (Caris Dx), a leading provider of the highest quality diagnostic, translational development and pharmaceutical services encompassing anatomic pathology and molecular testing, announced today the offering of Target GI to physicians nationwide. Target GI is designed to provide information on the expression of key molecular targets present in colon cancer, providing physicians the most up-to-date information to help in the management of their patients. The Target GI test includes analysis of a key group of biomarkers that have been identified as relevant in clinical studies on colon cancer. These biomarkers include KRAS (Proto-oncogene of the Kirsten murine sarcoma virus) by mutational analysis and TS (thymidylate synthase) and TOPO1 (topoisomerase 1) by immunohistochemical analysis. Patient tumors that have somatic mutations in KRAS have been associated with a lack of response to cetuximab and panitumumab. Patients with metastatic colorectal cancer over-expressing TS... http://www.biohouston.org/en/rel/?130 noemail@biohouston.org Mon, 11 Aug 2008 14:00:00 GMT Release http://www.biohouston.org/en/rel/?117 July 29, 2008 -- Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, announced today that it has successfully completed a Phase 1 multiple-dose escalation study in normal volunteers with LX1031, its oral drug candidate for irritable bowel syndrome (IBS). The company plans to progress the new drug candidate into Phase 2 studies in the fourth quarter. LX1031 is one of four programs in human clinical trials as part of Lexicon’s 10TO10 program. LX1031 will be our second drug candidate to enter Phase 2 testing, said Arthur T. Sands, M.D., Ph.D., president and chief executive officer. Our drug discovery strategy is continuing to produce a pipeline of drug candidates working through novel mechanisms that could ultimately enhance the lives of patients worldwide. The recently completed trial was a randomized, double-blind, ascending multiple-dose study in which all dose levels were well tolerated over 14... http://www.biohouston.org/en/rel/?117 noemail@biohouston.org Tue, 29 Jul 2008 05:00:00 GMT Release http://www.biohouston.org/en/rel/?131 The ability of Electronic Brachytherapy to accurately and consistently deliver localized, non-radioactive radiation treatment directly to cancer sites is the focus of a symposium and multiple research papers accepted for presentation at the 50th American Association of Physicists in Medicine Meeting, July 27 – 31 in Houston. According to Xoft, Inc., developer of the Axxent® Electronic Brachytherapy System, positive clinical results from initial breast cancer treatment experience has generated significant momentum for adoption of Electronic Brachytherapy (eBx). It has also spurred much research validating eBx use in additional applications, including the treatment of endometrial and endocavitary cancers. In conjunction with the AAPM Meeting, Xoft is hosting a luncheon symposium, titled Clinical and Regulatory Considerations for Electronic Brachytherapy. Featuring a panel of leading physicists and radiation biology experts, the panel discussion will focus on breast cancer... http://www.biohouston.org/en/rel/?131 noemail@biohouston.org Mon, 28 Jul 2008 14:00:00 GMT Release http://www.biohouston.org/en/rel/?116 July 23, 2008 -- Introgen Therapeutics, Inc., a developer of targeted molecular therapies for cancer, today reported additional efficacy data from the companys recent regulatory filings seeking approval of ADVEXIN(R) (p53 tumor suppressor therapy) in the United States and Europe. These findings resulted from supportive statistical analyses based on data from the pivotal Phase 3 clinical trial of ADVEXIN in patients with recurrent, refractory head and neck cancer. These analyses (Cox Regression) evaluated the length of survival of patients in the biomarker population receiving ADVEXIN as compared to patients in the biomarker population receiving methotrexate. Results showed that patients with p53 tumor profiles positive for ADVEXIN efficacy demonstrated statistically significant increased survival benefit at both six months (p less than 0.0051) and overall (p = 0.0265) following treatment with ADVEXIN. Additionally, these analyses showed that for patients with tumor p53 profiles... http://www.biohouston.org/en/rel/?116 noemail@biohouston.org Wed, 23 Jul 2008 05:00:00 GMT Release http://www.biohouston.org/en/rel/?115 July 22, 2008 -- OncoVista Innovative Therapies, Inc., a biopharmaceutical company engaged in the development and commercialization of targeted cancer therapies and diagnostics, announced today that patient recruitment has commenced in the companys Phase I/II study of cordycepin for the treatment of patients with terminal deoxynucleotidyl transferase (TdT)-positive refractory leukemia. Participating clinical sites include the Dana Farber Cancer Institute (Boston, MA) and the Cancer Therapy and Research Center (San Antonio, TX). Initiation of this Phase I/II clinical trial of cordycepin is an important milestone for OncoVista. We believe cordycepin will prove to be an effective and well-tolerated treatment option for many leukemia patients who do not respond to other therapies. We are very excited to have the trial up and running. stated Alexander L. Weis, Ph.D., President and Chief Executive Officer of OncoVista Innovative Therapies. OncoVista has received Orphan Drug Designation from... http://www.biohouston.org/en/rel/?115 noemail@biohouston.org Tue, 22 Jul 2008 12:00:00 GMT Release http://www.biohouston.org/en/rel/?114 July 22, 2008 -- Opexa Therapeutics, Inc., a company leading in the development of cell therapies for multiple sclerosis (MS) and diabetes, has completed an internal assessment of data from its Phase I/II two year extension study with Tovaxin in patients with MS. While confirming the favorable safety and efficacy profile of Tovaxin, further analysis also confirms both the benefit of consecutive annual treatments with Tovaxin and the advantage of tailoring each vaccination to the patient’s changing disease profile. The extension study evaluated 22 intent-to-treat patients that had enrolled in two Phase I/II open-label clinical studies with Tovaxin. 13 patients were enrolled with Relapse Remitting Multiple Sclerosis (RRMS) and 9 with Secondary Progressive Multiple Sclerosis (SPMS). After the first annual course of treatment the company conducted an analysis of each patient’s specific disease profile and myelin peptide epitope profile using Opexa’s proprietary Epitope Analysis Assay... http://www.biohouston.org/en/rel/?114 noemail@biohouston.org Tue, 22 Jul 2008 12:00:00 GMT Release http://www.biohouston.org/en/rel/?113 July 16, 2008 -- Repros Therapeutics Inc. today released strong results from its completed extension safety study of Proellex in the chronic treatment of the symptoms associated with uterine fibroids. To date there have been no abnormal histological findings from the endometrial biopsies taken post menses after cessation of drug administration. As of this release, results from 13 women who had endometrial biopsies post menses following last dose of drug in a two-drug cycle extension study of Proellex in the treatment of symptoms associated with uterine fibroids are available. These women have been exposed to Proellex for one three-month and two four-month drug cycles to help control the symptoms of their uterine fibroids. These three cycles have covered a span of two and one half years which exceeds current FDA guidance for the duration of exposure to hormonal drugs. The biopsies have been read by a panel of three expert pathologists all of whom will remain blinded to the treatment... http://www.biohouston.org/en/rel/?113 noemail@biohouston.org Wed, 16 Jul 2008 22:45:00 GMT Release http://www.biohouston.org/en/rel/?112 July 8, 2008 -- Opexa Therapeutics, Inc., a company leading in the development of cell therapies for multiple sclerosis announced today that the Data Safety Monitoring Board (DSMB) overseeing the on-going Phase IIb clinical study of Tovaxin has recommended that the trial continue unmodified. This positive recommendation follows a regularly scheduled meeting of the DSMB in June and is based upon an evaluation of clinical, magnetic resonance imaging (MRI) and safety data that had been recorded for all patients to date. The TERMS trial (Tovaxin for Early Relapsing Multiple Sclerosis) is nearing completion and the DSMB has two additional scheduled meetings in July and August of this year. Tovaxin is being evaluated in a multi-center, randomized, double blind, placebo controlled study in 150 patients suffering from Relapse Remitting Multiple Sclerosis (RRMS) or Clinically Isolated Syndrome (CIS). The trial was initiated in the third quarter of 2006 and enrollment was completed in the... http://www.biohouston.org/en/rel/?112 noemail@biohouston.org Tue, 08 Jul 2008 12:00:00 GMT Release http://www.biohouston.org/en/rel/?111 July 03, 2008 -- Introgen Therapeutics, Inc. today announced a re-allocation of employees to focus on regulatory review and commercial activities. After years of product development, Introgen is directing corporate spending toward regulatory review programs, commercialization and the future marketing of ADVEXIN therapy. Recently the Company achieved the major corporate milestone of filing for regulatory approval of ADVEXIN cancer therapy in the U.S. and Europe. From its current total of approximately 70 employees, Introgen will eliminate approximately 20 positions primarily associated with ADVEXIN development and regulatory submission programs that have now been completed. Some of the approximately 50 remaining Introgen employees and some new employees are expected to join Introgens manufacturing subsidiary, Introgen Technical Services, Inc. The Company anticipated reductions in ADVEXIN program expenses contained in previous financial guidance. These steps will allow Introgen to... http://www.biohouston.org/en/rel/?111 noemail@biohouston.org Thu, 03 Jul 2008 05:00:00 GMT Release http://www.biohouston.org/en/rel/?110 July 1, 2008 -- Fifteen students are spending the summer at NASA Johnson Space Center, working alongside space life scientists and space medicine researchers as part of the National Space Biomedical Research Institute’s Summer Internship Program. As the International Space Station nears completion, these young scientists are getting a taste of health and medical research related to living in space for long periods and to sending humans back to the moon. The 10-to-15 week program provides the opportunity for undergraduate, graduate and medical students to join ongoing research activities at NASA. The 2008 NSBRI Summer Interns and their home institutions are: -Teresa Ai, Duke University -Justin Barba, Texas A&M University -Michelle Bruner, Mars Hill College -John Cackler, Stanford University -Pushan Dasgupta, Harvard University -James Fiedler, Iowa State University -Lauren Frost, West Virginia University -Jennifer Hirt, University of Kansas Medical Center -Stephanie... http://www.biohouston.org/en/rel/?110 noemail@biohouston.org Tue, 01 Jul 2008 05:00:00 GMT Release http://www.biohouston.org/en/rel/?107 June 30, 2008--Introgen Therapeutics, Inc. submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) requesting marketing approval for ADVEXIN(R) p53 therapy to treat recurrent, refractory head and neck cancer. Simultaneously, Gendux Molecular Limited, an Introgen subsidiary, submitted a Marketing Authorization Application (MAA) to the European Medicines Evaluation Agency (EMEA) for the same indication. ADVEXIN represents the first of a new class of tumor suppressor cancer therapy and is the first of its kind to be submitted for regulatory approval in the United States and Europe. Introgen has requested Priority Review from the FDA for ADVEXIN. Priority Review is typically granted to compounds that provide significant medical benefit compared to existing treatments for a disease. If Priority Review is granted, the FDA will have up to six months from submission date to take action on the dossier. ADVEXIN is considered an Orphan Drug in the US for... http://www.biohouston.org/en/rel/?107 noemail@biohouston.org Mon, 30 Jun 2008 13:30:00 GMT