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Key To Improving Prognosis In Acute Heart Failure - Better Treatment Selection And Improved Therapies
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Biotech Leaders, Patient Advocates Highlight Cutting-Edge HIV/AIDS Therapies, Need For Next Generation Treatments
Leaders in biotechnology research and patient advocacy joined forces today at the 2009 BIO International Convention to discuss the latest breakthroughs in HIV/AIDS treatments. Following a keynote speech by Sir Elton John focused on the needs of the HIV/AIDS community, representatives of biotech companies previewed the next generation of treatments while patient advocates reiterated the need for new therapies, particularly for those who have developed resistance to existing medications. Researchers are developing new therapies that are more effective in treating HIV/AIDS, including an AIDS vaccine and new methods of delivery that hold the potential to increase patient compliance.
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AdvanDx Receives FDA 510(k) Clearance For GBS PNA FISH(R) For Rapid Detection Of Group B Strep From Lim Broths
AdvanDx announced it received FDA 510(k) clearance for GBS PNA FISH(R) for detection of Streptococcus agalactiae, aka Group B Strep, from turbid Lim Broths inoculated with vaginal and rectal swabs obtained from pregnant women between 35 and 37 weeks gestation. The 90 minute molecular diagnostic test enables rapid and highly sensitive detection of Group B Strep from Lim Broths to help detect colonization in pregnant women.
Public Health

IOPHARM Presents Positive Indibulin Translational And Dose Scheduling Data At ASCO

ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) announced today that it presented positive data from both a Phase Ib clinical trial and preclinical dosing studies of orally administered indibulin (ZybulinTM or ZIO-301), the Company"s novel tubulin binding agent, at the 45th Annual American Society of Clinical Oncology (ASCO) meeting held in Orlando, FL, May 29th to June 2nd. In the Phase Ib study, oral indibulin was administered with oral capecitabine (XelodaTM) in patients with advanced solid tumors. Trial results presented are for 7 patients who had received a median of three prior therapies. All 7 patients were evaluable for safety, and 4 for efficacy. Three patients had stable disease for a minimum of 6 cycles with 1 patient ongoing in their 11th cycle of treatment. There were no dose limiting toxicities and therefore no maximum tolerated dose was established. Adverse events included hand-and-foot syndrome (capecitabine), fatigue, vomiting, loss of appetite and headaches, and were easily managed. There was no reported neurotoxicity, consistent with other Phase I and preclinical data with indibulin. There was early activity seen in breast, colon, bladder and prostate cancers with this sub-optimal dose level and schedule, which is encouraging with regard to further study using mathematically-optimized dose scheduling, the subject of the preclinical data also presented. The preclinical results were derived from mathematical modeling applying Norton-Simon models in breast cancer xenografts. The work was conducted by the Company under the direction of Dr. Larry Norton (Harmon Hill). Formal analyses revealed that the major effect of therapy occurs in five days of exposure, which is not manifest on gross inspection until one week thereafter. Therefore an intermittent schedule based on five days of drug administration preserves full activity while minimizing the possibility of toxicity. A Phase I/II study in breast cancer using this highly novel scheduling strategy is in development under the direction of two leading breast cancer specialists, Dr. Clifford Hudis in the United States and Dr. Jose Baselga in Spain. "Indibulin is not only an interesting drug because it is active against taxane-resistant cells without the neurotoxicity seen with all the other tubulin binding agents, but also because mathematical modeling has revealed a novel dose-schedule that promises to maximize efficacy and minimize toxicity in the clinic. Also, it is oral, so it is potentially of value to the entire world"s population", commented Dr. Larry Norton, senior author on this presentation. To view the presentation please visit here. ZIOPHARM Oncology, Inc.


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