Urology Product Guide

KAI Pharmaceuticals Announces Initiation Of Phase 1b Study Of KAI-4169 For The Treatment Of Secondary Hyperparathyroidism (SHPT)

Seth Sullivan — Wed, 29 Sep 2010 14:46:52 +0000

KAI Pharmaceuticals, Inc. announced enrollment of the first patients in a Phase 1b study of KAI-4169, a novel pharmaceutical agent being tested for the treatment of secondary hyperparathyroidism (SHPT), which is a frequent and serious complication of end-stage renal disease (ESRD). The Phase 1b study is a double-blind, randomized, placebo-controlled, crossover study to assess the safety and tolerability of single ascending doses of KAI-4169 in ESRD patients with SHPT undergoing hemodialysis.

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Genta Initiates New Trial Of Tesetaxel, The Leading Clinical-Stage Oral Taxane, In Patients With Advanced Bladder Cancer

Seth Sullivan — Wed, 29 Sep 2010 14:41:23 +0000

Genta Incorporated announced that the Company has initiated a new Phase 2 clinical trial of tesetaxel in patients with advanced bladder cancer. The new trial will be conducted at Memorial Sloan-Kettering Cancer Center, New York, NY, the Kimmel Cancer Center at Jefferson University, Philadelphia, PA, and at least one site in the EU. The new study will examine the efficacy and safety of tesetaxel in patients with advanced bladder cancer.

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FibroGen Announces Chinese State FDA Approval Of Phase 1 And 2 Development Of FibroGen Oral Anemia Therapy, FG-4592

Seth Sullivan — Fri, 24 Sep 2010 15:10:04 +0000

FibroGen, Inc. announced that its investigational oral anemia therapy, FG-4592, received Clinical Trial Application (CTA) approval from the Chinese State Food and Drug Administration (SFDA) to commence clinical development for the treatment of anemia associated with chronic kidney disease (CKD) in the People’s Republic of China. FG-4592 is a first-in-class hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor (PHI) entering Phase 2b clinical development in the US and Europe for the treatment of CKD anemia.

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The Karmanos Cancer Center One Of The First In Michigan To Use PROVENGE, The New FDA-Approved Drug For Advanced Prostate Cancer

Seth Sullivan — Fri, 24 Sep 2010 15:08:09 +0000

The Barbara Ann Karmanos Cancer Center in Detroit was recently selected to be one of 50 sites in the United States to offer the new U.S. Food and Drug Administration (FDA)-approved drug PROVENGE® (sipuleucel-T) to treat patients with advanced metastatic prostate cancer. PROVENGE, manufactured by Dendreon, is the first FDA-approved autologous cellular immunotherapy, a breakthrough treatment that uses the patient’s own immune system to fight the prostate cancer.

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Arcion Therapeutics Receives FDA Fast Track Designation For ARC-4558 For The Treatment Of Pain Associated With Painful Diabetic Neuropathy

Seth Sullivan — Thu, 16 Sep 2010 17:27:12 +0000

Arcion Therapeutics announced that the FDA has granted Fast Track designation to ARC-4558 for the treatment of pain associated with Painful Diabetic Neuropathy (PDN). ARC-4558 is a 0.1% gel formulation of clonidine hydrochloride for topical administration. Arcion recently announced positive top-line results from a Phase 2b double-blind, randomized, placebo-controlled clinical trial of ARC-4558 in adult patients with PDN. The Company also recently held an End of Phase 2 meeting with the FDA.

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Experimental Drug For Polycystic Kidney Disease Decreases Size And Number Of Cysts In Animal Model

Seth Sullivan — Thu, 16 Sep 2010 17:21:29 +0000

In work suggesting a new approach to treating polycystic kidney disease (PKD), a leading cause of kidney failure, researchers at Children’s Hospital Boston were able to block the formation of fluid-filled cysts, the hallmark of the disease, in a mouse model. Their findings, using a compound that inhibits a receptor known as c-Met, were published in the September 13th online edition of the Journal of Clinical Investigation.

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CytRx Initiates Phase 2 Clinical Trial With Bafetinib In Advanced Prostate Cancer

Seth Sullivan — Fri, 10 Sep 2010 09:14:17 +0000

CytRx Corporation announced initiation of the PROstate Advanced Cancer Treatment (PROACT) Phase 2 proof-of-concept clinical trial to evaluate the efficacy and safety of bafetinib in patients with advanced prostate cancer. The open-label PROACT trial is being conducted at City of Hope, located just outside of Los Angeles, California, as well as multiple clinical sites in India. In the trial, approximately 50 patients with metastatic hormone-refractory prostate cancer will receive orally available bafetinib twice daily.

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Agensys, An Affiliate Of Astellas, Announces Initiation Of Phase I Clinical Trial Of AGS-16M8F For Renal Cancer

Seth Sullivan — Fri, 10 Sep 2010 09:08:37 +0000

Agensys, Inc. announced that they have initiated a Phase I clinical trial of AGS-16M8F an antibody-drug conjugate (ADC) that is being developed for the treatment of metastatic renal cancer. An ADC uses the specific binding properties of an antibody to target a toxin in tumor cells, resulting in selective tumor cell killing. The single-agent, Phase I, dose-escalation study will evaluate the safety of AGS-16M8F in patients with renal cancer and identify the maximum tolerated dose.

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Bladder Cancer Risk May Be Decreased By Increasing Selenium Intake

Seth Sullivan — Fri, 03 Sep 2010 07:08:15 +0000

A common mineral may provide protection against bladder cancer. According to results of a study published in the September issue of Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research, selenium intake is associated with decreased risk of bladder cancer. Selenium is an essential micronutrient that is incorporated into about 25 proteins, called selenoproteins. Most of these selenoproteins are enzymes with antioxidant properties that prevent cellular damage.

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Amneal Announces FDA Approval For Spironolactone HCl Tablets

Seth Sullivan — Fri, 03 Sep 2010 07:04:14 +0000

Amneal Pharmaceuticals, LLC has announce that it has received U.S. FDA approval to manufacture Spironolactone HCl tablets in 25 mg, 50 mg and 100 mg strengths effective July 2, 2010. The Amneal generic is an AB-rated, therapeutically equivalent alternative to Aldactone® (a registered trademark of Pharmacia & Upjohn, Inc., a unit of Pfizer Inc.). Annual U.S. sales of Spironolactone HCl were $91 MM as of December 2009 according to IMS Health market data.

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