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Infinity commences IPI-926 Phase 2 trial in patients with pancreatic cancer

Infinity Pharmaceuticals, Inc. today announced the initiation of the randomized Phase 2 portion of the trial of IPI-926 in combination with gemcitabine in patients with previously untreated, metastatic, pancreatic cancer.

22 Feb 2011

KemPharm commences KP201 Phase 1 trial for pain

KemPharm, Inc. today announced that it has commenced a Phase 1 clinical trial in healthy volunteers with KP201, its novel abuse deterrent prodrug of hydrocodone for pain. KP201 is a new chemical entity and is the most advanced opioid-based lead candidate in KemPharm's emerging pipeline.

22 Feb 2011

Pieris: New interim PRS-050 Phase I data against cancer to be presented at Tri-Conference in California

Pieris AG announced today the upcoming presentation of new preclinical and interim Phase I clinical trial data for its PRS-050 Anticalin(r) program, currently under evaluation for the treatment of cancer.

22 Feb 2011

Positive preliminary data from Fate Therapeutics FT1050 Phase 1b trial in patients with life-threatening conditions

Fate Therapeutics, Inc. presented encouraging preliminary data from an ongoing Phase 1b clinical trial of FT1050 at the 2011 BMT Tandem Meetings in Honolulu, Hawaii.

22 Feb 2011

Pharming, Santarus begin RHUCIN Phase IIIb study in patients with Hereditary Angioedema

Specialty biopharmaceutical company Santarus, Inc. and biotech company Pharming Group NV (NYSE Euronext: PHARM) today announced that Pharming has begun an international, multicenter, randomized, placebo-controlled Phase IIIb clinical study evaluating the investigational drug RHUCIN for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema.

22 Feb 2011

Positive results from TMC435 phase 2b PILLAR study in treatment-naive patients with HCV

Medivir AB, the emerging research-based specialty pharmaceutical company focused on infectious diseases, announces today further positive results from the phase 2b PILLAR study of TMC435 in treatment-naive patients with hepatitis C virus genotype-1.

22 Feb 2011

Advancell announces positive results from Acadra clinical study in Chronic Lymphocytic Leukemia

ADVANCELL, an emerging biopharmaceutical company, today announced positive results from a clinical study conducted with Acadra (Acadesine) in Chronic Lymphocytic Leukemia patients resistant to current therapies. The company also announced promising non-clinical results in Multiple Myeloma (MM), Mantle Cell Lymphoma (MCL) and other lymphoproliferative disorders. Synergism of Acadra in combination with current treatment in these indications has been demonstrated.

21 Feb 2011

Synexus creates specialist vaccines team to help pharma and biotech companies

Synexus has created a specialist vaccines team to help pharma and biotech companies find the thousands of patients they need for their late phase trials. The company has a well-established reputation for delivering results in the vaccine field following successes in late phase vaccine trials including most recently, studies for cancer prevention, influenza and rotavirus where it has delivered in excess of three thousand randomised patients in all three areas.

From AES - Accelerated Enrollment Solutions 21 Feb 2011

Bangladesh cholera vaccine trial

Bangladesh will conduct the world’s largest clinical trial of an affordable cholera vaccine which could save tens of thousands of lives. The study began Thursday and involves nearly 250,000 people near the capital, Dhaka.

20 Feb 2011

Protalix: New data from taliglucerase alfa, oral GCD trials to be presented at Lysosomal Disease Network Symposium

Protalix BioTherapeutics, Inc., announced today that new clinical data from the switchover trial of taliglucerase alfa in Gaucher disease patients and preclinical data on oral enzyme glucocerebrosidase (oral GCD) will be presented today at the 7th Annual Meeting of the Lysosomal Disease Network: WORLD Symposium 2011 in Las Vegas, Nevada.

19 Feb 2011

Genzyme reports 3-year follow-up data from eliglustat tartrate Phase 2 trial for Gaucher disease

Genzyme Corporation today announced three-year follow-up data from patients enrolled in the phase 2 clinical trial for its investigational oral therapy for Gaucher disease type 1 known as eliglustat tartrate. Sustained or further improvements were observed across all endpoints, including bone disease, at the three-year timepoint.

19 Feb 2011

Phase I/II safety, efficacy data for Bellicum's BPX-101 presented at 2011 Genitourinary Cancers Symposium

Bellicum Pharmaceuticals, Inc. today announced the presentation of Phase I/II safety and efficacy data for BPX-101, a novel drug-activated dendritic cell vaccine for metastatic castrate resistant prostate cancer (mCRPC), in three separate posters at the 2011 Genitourinary Cancers Symposium held in Orlando, Florida on February 17 – 19, 2011.

19 Feb 2011

EMA grants Prima BioMed Scientific Advice for CVac ovarian cancer vaccine Phase III trial

Australian health care company Prima BioMed Ltd announced today that there has been an agreement for strategy and design of the Phase III clinical registration trial for the CVac™ immunotherapy therapeutic ovarian cancer vaccine.

19 Feb 2011

FDA grants CSL Behring marketing approval for Corifact in treatment of congenital FXIII deficiency

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Corifact™, Factor XIII Concentrate (Human), for the routine prophylactic treatment of congenital factor XIII (FXIII) deficiency. Corifact, already available for use in 12 countries throughout the world under the trade name Fibrogammin®- P, is the first and only FXIII concentrate approved in the U.S.

19 Feb 2011

Novavax announces final safety, immunogenicity results from H1N1 VLP vaccine at WHO meeting

Novavax, a clinical-stage biopharmaceutical company, today presented the final safety and immunogenicity results from its 2009 H1N1 virus-like particle pandemic influenza vaccine clinical trial in Mexico at the invitation-only 7th World Health Organization Meeting on Evaluation of Pandemic Influenza Vaccines in Clinical Trials.

19 Feb 2011

Tibotec begins enrollment in TMC435 phase 3 trial for treatment of HCV

Medivir AB, the emerging research-based specialty pharmaceutical company focused on infectious diseases, notes that its development partner, Tibotec Pharmaceuticals, announced today that the global phase 3 studies with TMC435 in treatment-naive patients and patients who have relapsed after prior SOC treatment have started.

18 Feb 2011

Positive interim data from cabozantinib Phase 2 metastatic castration-resistant prostate cancer trial

Exelixis, Inc. today reported updated interim data from the cohort of patients with metastatic castration-resistant prostate cancer (CRPC) treated with cabozantinib (XL184) in an ongoing phase 2 adaptive randomized discontinuation trial.

18 Feb 2011

BDSI announces over 50% enrolled in BEMA Buprenorphine Phase 3 study in chronic pain

BioDelivery Sciences International, Inc. announced today that enrollment of its Phase 3 trial assessing the efficacy and safety of BEMA Buprenorphine for the treatment of moderate to severe chronic pain is on schedule, with over half of the needed subjects enrolled.

18 Feb 2011

Urocidin Phase III non-muscle-invasive bladder cancer trial interim results to be presented at EAU, AUA conferences

Endo Pharmaceuticals and Bioniche Life Sciences Inc. today announced plans for peer-reviewed presentation of interim efficacy and safety results from the first Phase III trial of the intravesical formulation of Mycobacterial cell wall-DNA complex (MCC), known as Urocidin™ or EN3348.

18 Feb 2011

Apricus Bio in discussions with FDA for PrevOnco SPA Phase III protocol

Apricus Biosciences, Inc., announced today that it is currently in discussions with the U.S. Food and Drug Administration ("FDA") relating to the PrevOnco™ Special Protocol Assessment ("SPA") Phase III protocol submitted by the Company in December 2010.

18 Feb 2011

Drug Trial News

Infinity commences IPI-926 Phase 2 trial in patients with pancreatic cancer

KemPharm commences KP201 Phase 1 trial for pain

Pieris: New interim PRS-050 Phase I data against cancer to be presented at Tri-Conference in California

Positive preliminary data from Fate Therapeutics FT1050 Phase 1b trial in patients with life-threatening conditions

Pharming, Santarus begin RHUCIN Phase IIIb study in patients with Hereditary Angioedema

Positive results from TMC435 phase 2b PILLAR study in treatment-naive patients with HCV

Advancell announces positive results from Acadra clinical study in Chronic Lymphocytic Leukemia

Synexus creates specialist vaccines team to help pharma and biotech companies

Bangladesh cholera vaccine trial

Protalix: New data from taliglucerase alfa, oral GCD trials to be presented at Lysosomal Disease Network Symposium

Genzyme reports 3-year follow-up data from eliglustat tartrate Phase 2 trial for Gaucher disease

Phase I/II safety, efficacy data for Bellicum's BPX-101 presented at 2011 Genitourinary Cancers Symposium

EMA grants Prima BioMed Scientific Advice for CVac ovarian cancer vaccine Phase III trial

FDA grants CSL Behring marketing approval for Corifact in treatment of congenital FXIII deficiency

Novavax announces final safety, immunogenicity results from H1N1 VLP vaccine at WHO meeting

Tibotec begins enrollment in TMC435 phase 3 trial for treatment of HCV

Positive interim data from cabozantinib Phase 2 metastatic castration-resistant prostate cancer trial

BDSI announces over 50% enrolled in BEMA Buprenorphine Phase 3 study in chronic pain

Urocidin Phase III non-muscle-invasive bladder cancer trial interim results to be presented at EAU, AUA conferences

Apricus Bio in discussions with FDA for PrevOnco SPA Phase III protocol

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