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Responses After Completion of Therapy Increase Pixantrone Complete Remission (CR)/Unconfirmed Complete Remission (CRu) Rate to 24% and Overall Response Rate (ORR) to 40% Compared to 7% and 14% for Comparator Agents in Phase III EXTEND Trial in 3rd Line Th

SEATTLE, June 22 /PRNewswire-FirstCall/ -- Updated follow-up phase III EXTEND (PIX 301) clinical trial data enhances previously reported superior response rates for pixantrone over comparator including in high risk patient subgroups Additional Clinical Studies Also Highlighted at Pan ...

CardioVascularCS.Org, a division of EndoVascular Forum, Inc., Partners with Complex Interventional Cardiovascular Therapy (CICT) to Extend Electronic Medical Care Advancement

CardioVascularCS.Org and CICT collaborate by reconstructing cardiovascular clinical experiences presented virtually at the annual CICT conference BOSTON, June 2 /PRNewswire/ -- The EndoVascular Forum, Inc. (EVF), an IC Sciences Company, and its partner Complex Interventional Cardiovascular T...

Bayer and Regeneron Extend Development Program for VEGF Trap-Eye to Include Central Retinal Vein Occlusion

Two Phase 3 studies to start in the second half of this year BERLIN and TARRYTOWN, N.Y., April 30 /PRNewswire-FirstCall/ -- Bayer HealthCare AG and Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN ) today announced that the companies are extending their global development program for VEGF Trap...

Cell Therapeutics, Inc. (CTI) Announces Enrollment Complete in Phase III EXTEND (PIX301) Clinical Trial of Pixantrone in Patients With Second or Greater Relapse of Diffuse Large B Cell NHL

Potential NDA Submission in 2009 SEATTLE, March 25 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC ; MTA) announced today that enrollment is complete in the phase III EXTEND (PIX301) clinical trial of pixantrone (BBR2278) for patients with relapsed di...

FDA Grants Approval to Extend U.S. Enrollment and Clinical Trial

Ablation Frontiers Uses Novel Technology in Treatment of Chronic Atrial Fibrillation Patients CARLSBAD, Calif., Jan. 16 /PRNewswire/ -- Ablation Frontiers, Inc. today announced the expansion of enrollment in the first ever U.S. Investigational Device Exemption (IDE) cli...

FDA to Extend Review of Data Quality Submission for Genasense(R) in Melanoma

BERKELEY HEIGHTS, N.J., Dec. 21 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq: GNTA ) announced today that the Company has received notice from the Food and Drug Administration (FDA) that FDA has extended its review period of Genta's request for correction of certain information that w...

Study Published in Endocrinology Reports Potential of Modigene Technology to Extend Duration of Protein Drugs

- Publication in Leading Peer-Reviewed Journal Represents Further Scientific Validation of the Potential Utility of Modigene's CTP Technology - VIENNA, Va., Sept. 24 /PRNewswire-FirstCall/ -- Modigene Inc. (OTC Bulletin Board: MODG) today reported that rese...

Access Pharmaceuticals Provides Update on ProLindac Clinical Development Program

...l examine dose levels and regimens of ProLindac monotherapy in cancer patients, provide additional data to support design of combinations studies, and extend the safety database. Two ovarian cancer patients have been enrolled in the study to date, and it is anticipated 6 to 12 patients will be enrolled this...

Human Genome Sciences and GlaxoSmithKline Announce Positive Phase 3 Study Results for BENLYSTA(TM) in Systemic Lupus Erythematosus

...tially important therapeutic advance to patients suffering from SLE." Key Findings from BLISS-52 "The BLISS-52 results support and extend the findings that emerged in the serologically active subgroup of SLE patients at Week 52 in our Phase 2 trial," said David C. Stump, M.D., Executive ...

Bioniche Life Sciences Inc. and Endo Pharmaceuticals Sign Licensing Agreement for Urocidin(TM)

... August Endo plans to launch Valstar(TM), for the treatment of bladder cancer. If successful in clinical development, Urocidin has the potential to extend and enhance our recent therapeutic expansion and strengthen the Valstar franchise." Graeme McRae, Chairman, President & CEO of Bioniche, ad...

New Review on PROSTVAC(TM) Published by Key Investigators From NCI

...ccine moving into late stage clinical development that has the potential to extend the lives of people with advanced prostate cancer. Administered subcutaneou... with numerous side effects. In contrast, PROSTVAC(TM) has the potential to extend survival with improved quality of life. PROSTVAC is being developed in coll...

Alfacell Provides Shareholder Update

...s ability to overcome MDR, I believe that Onconase remains a viable candidate for second line therapy in MM. The fact that Onconase was able to extend the lives of patients who had failed a prior chemo therapy was not lost in our thoughts. About a year ago, we engaged Champions Biotechnology, to con...

Cephalon Provides Clinical Update on Lestaurtinib in Relapsed Acute Myelogenous Leukemia

... Cephalon, a leading biopharmaceutical company, is building a diversified portfolio of oncology products that represents a comprehensive approach to extend and enhance the lives of patients with cancer. Cephalon Oncology is a strategic business unit focused on the development and commercialization of onco...

Cepheid Receives Grant to Develop Ten-Color Real-Time PCR Detection Technology for Use in the GeneXpert(R) System

... New Capabilities Will Further extend GeneXpert System Technology Advantages SUNNYVALE, Calif., June 10 /PRNewswire-FirstCall/ -- Cepheid (Nasdaq: CPHD ) today announced that it has...

Afinitor(R) Phase II Data Show Positive Results for Patients With Multiple Types of Lymphoma, Leading to Phase III Trial

...ho achieved complete remission with first-line rituximab combined with chemotherapy. This worldwide study will evaluate the potential of everolimus to extend disease-free survival in patients with DLBCL. The longer a patient with DLBCL is in remission the higher their likelihood to remain disease-free. Ther...

IBM and EU Partners Create a Better Way to Fight AIDS Virus

...iction of the right combination of drugs that works for the maximum amount of time." These innovations are being provided as a free tool that can help extend the lives of millions of people who are the victims of this disease. The system's predictions are near 76% accurate, outperforming other common...

Pixantrone Produces High Rates of Complete and Partial Remissions Even Among Aggressive NHL Patients With Extensive Prior Doxorubicin Treatment or Prior Rituximab Treatment

...oup analysis data were reviewed from the phase III extend (PIX 301) clinical trial of pixantrone (the "PIX 301 extend trial") demonstrating the effectiveness of pixantr... Twenty-five of the 70 patients in the PIX 301 extend trial had received prior cumulative doxorubicin do...

Neurobiological Technologies' Partner, Celtic Pharma, Announces Results of XERECEPT(R) Phase 3 Clinical Program

...TM) (ancrod), which was studied in Phase 3 clinical trials as a potential new drug to treat acute ischemic stroke. NTI has more recently chosen not to extend its early-stage research programs for Huntington's and Alzheimer's diseases. NTI has rights to receive payments from an approved drug for Alzheimer's ...

Entremed Presents Results of ENMD-2076 Phase 1 Study in Advanced Cancer Patients

...ising solid tumor indications for further study in Phase 2. The recent initiation of Phase 1 studies in multiple myeloma and leukemia will allow us to extend the possible indications for ENMD-2076 into hematological malignancies where preclinical data have been encouraging. These data and the initiation of...

Heart Disease Treatment Breakthrough

...f you think that this can reduce the damage to the arteries, which is the damage that ends up causing heart attacks and strokes - this can potentially extend life but also saving lives on a global basis. "The potential impact is enormous - we might see a fall in the number of people suffering heart a...

Invitation: PROSTVAC(TM) Wrap up

... About PROSTVAC(TM) PROSTVAC(TM) is a therapeutic vaccine moving into late stage clinical development. PROSTVAC(TM) has the potential to extend survival with improved quality of life in patients with advanced prostate cancer. About Bavarian Nordic Bavarian Nordic A/S is a leading...

Bethesda-Based NHSi Wins $2M Grant for Blood Technology

...gen and more deformable red blood cells for better capillary perfusion, and extend by 50 percent or more the shelf life of stored red blood cells. The S...ls (RBCs) of higher efficacy for transfusion therapy, and at the same time, extend the shelf life of refrigerated RBCs. For more information on the company a...

Dainippon Sumitomo Pharma Announces Lurasidone Phase III Data in Patients With Schizophrenia

...lans on the horizon, this multi-billion dollar company has about 5,000 employees worldwide. Through its research and development efforts, DSP aims to extend our experience, commitment and vision worldwide. Located in Fort Lee, NJ, Dainippon Sumitomo Pharma America, Inc. is a subsidiary of DSP. ...

Pixantrone Phase 3 Data to be Presented at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting

... SEATTLE, May 15 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced that data from CTI's pivotal phase III extend (PIX301) trial of pixantrone in patients with advanced, relapsed aggressive non-Hodgkin's lymphoma (NHL) will be presented at the 2009 American Societ...

Boehringer Ingelheim to Present New Phase II Clinical Data on Two Lead Oncology Compounds at ASCO 2009

...tandard first-line or second-line chemotherapy and then received treatment with an EGFR TKI. The LUX-Lung 1 study will evaluate whether BIBW 2992 will extend the lives of these cancer patients,"(5) said Dr. Haehl. First Presentation of Phase II Data on BIBF 1120 in Ovarian Cancer Data from a Phas...

FDA Approves Vanda Pharmaceuticals' Fanapt(TM) for the Treatment of Schizophrenia

... colleagues, many investigators and thousands of patients who participated in the development of this new treatment for schizophrenia. I would like to extend my gratitude to all those who contributed and reaffirm the commitment of Vanda Pharmaceuticals to the discovery and development of medicines for those...

AstraZeneca Submits NDA for Low Dose Aspirin/Esomeprazole Combination Product

...bout NEXIUM (R) (esomeprazole magnesium) NEXIUM 20 mg is indicated to maintain symptom resolution and healing of EE (controlled studies did not extend beyond 6 months), and for treatment of heartburn and other symptoms associated with GERD. NEXIUM 40 mg and 20 mg daily are indicated for short-term t...

Neurobiological Technologies Reports Receipt of $1.5 Million Royalty Payment for Quarterly Sales of Memantine

...TM) (ancrod), which was studied in Phase 3 clinical trials as a potential new drug to treat acute ischemic stroke. NTI has more recently chosen not to extend its early-stage research programs for Huntington's and Alzheimer's diseases. NTI has rights to receive payments from an approved drug for Alzheimer's ...

ANA598 Demonstrates Potent Antiviral Activity at all Dose Levels in Completed Phase Ib Study in Hepatitis C Patients

...gement of clinical sites. 14 Day Healthy Volunteer Study Anadys recently completed dosing healthy volunteers in a 14-day study conducted to extend the safety and pharmacokinetic profile of ANA598. Thirty subjects participated in the study, with eight subjects receiving ANA598 and two subjects re...

Healthpoint Initiates Phase II, Dose-Finding Study to Evaluate Effectiveness of a Unique Cell Based Therapy in Venous Leg Ulcers

...nt program for this novel biologic therapy," commented Bert Slade, MD, FAAAAI, Chief Medical Officer at Healthpoint. "This second Phase II study will extend our understanding of this agent, which we believe will add to the promising results obtained in previous European clinical trials." The study is ...

InteKrin Therapeutics Announces Enrollment Completion of 360 Patient, 24 week Phase 2b Study

...lacebo controlled study of INT131 at four doses in poorly controlled Type 2 diabetics. "INT131-007 is an important study designed specifically to extend the encouraging findings from our Phase 2a study and demonstrate the unique properties of INT131, a potent insulin sensitizer, in patients with inadeq...

Isolagen, Inc. Submits Biologics License Application for the Treatment of Wrinkles to the U.S. Food and Drug Administration

...I am extremely proud of our employees and their efforts in accomplishing this significant goal for the Company. Further, I would like to recognize and extend my appreciation to our investigators and our regulatory and clinical advisors for all of their dedicated efforts." Mr. Daly continued, "In additi...

FDA Submission of B-R-A-H-M-S MR-proANP Kryptor

...rkers for the diagnosis, treatment and therapeutic management of life-threatening diseases. With its more than 400 employees, the company's goal is to extend its large portfolio of new biomarker tests for infectious and cardiovascular diseases as well as other clinical applications. B-R-A-H-M-S develops and...

Ascenta Therapeutics Announces Positive Preliminary Results with AT-101 in Docetaxel Refractory Prostate Cancer

...gator, Florida Cancer Specialists. "Our results to date suggest that stimulating cancer cell apoptosis through Bcl-2 pathways with AT-101 may in fact extend the clinical utility of docetaxel in this cohort of highly treatment-resistant patients." The analysis included data from 37 men with docetaxel-r...

MannKind Updates Status of NDA Submission for AFRESA

...Administration ("FDA") by the end of February. Based on editorial decisions made during the final stages of preparing the dossier, we have decided to extend the submission date by approximately three weeks. The document is fully drafted. However, we decided during our final review that it would be ...

IlluminOss Medical Announces First Human Case Utilizing a Unique, New, Minimally Invasive Technology for Fracture Repair is Performed at Medical Hospital del Trabajadar in Santiago, Chile

...minOss Photodynamic Bone Stabilization System was used on a 21 year old man with a fracture of the 5th metacarpal. The metacarpals are the bones that extend from the base of the wrist to the base of each finger at the knuckle. The fifth metacarpal runs to the little finger. According to Dr. von Unger...

Compared to Standard Therapies, Pixantrone Decreases Time to Achieve Complete Remission by 47% in Relapsed Aggressive Non-Hodgkin's Lymphoma

...gressive NHL a meaningful clinical benefit." CTI announced in November 2008 that it had achieved the primary efficacy endpoint of its phase III extend (PIX301) trial of pixantrone (BBR2778). Patients randomized to treatment with pixantrone achieved a high rate of confirmed and unconfirmed complete re...

Savient Provides Update on Pegloticase BLA

...ubmissions constituted a major amendment to the pegloticase BLA, which allowed the FDA under the Prescription Drug User Fee Act (PDUFA) regulations to extend the review period. In order to allow the agency time to consider these amendments, the FDA has notified the Company that the pegloticase BLA priority ...

Cell Therapeutics and IDIS Announce Agreement for a European Named Patient/Compassionate Use Program for Pixantrone

...sults have been confirmed in further studies," Dr Herbrecht added. The extend clinical trial was a phase III single-agent trial of pixantrone for patient...er 2008 that it had achieved the primary efficacy endpoint of its phase III extend (PIX301) trial of pixantrone (BBR2778). Patients randomized to treatment wi...

Medgenics Announces Positive Data From Phase I/II Clinical Trial of EPODURE Treatment of Anemia in Chronic Kidney Disease

...iopump is intended to increase efficacy, reduce side effects, and improve patient compliance and quality of life, as well as lower treatment costs and extend treatment to populations currently under-treated. Medgenics intends to develop its technology for a variety of chronic conditions, initially foc...
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