{tiny;CYTK;3}Cytokinetics, Incorporated (NASDAQ:CYTK) announced today the initiation of a double-blind, randomized, placebo-controlled, multiple-dose Phase I clinical trial to investigate the pharmacokinetic profile of CK-2017357. Cytokinetics also announced that the company has initiated the second part, or "Part B", of a previously initiated first-time-in-humans, Phase I clinical trial of CK-2017357 in healthy male volunteers. CK-2017357 is a fast skeletal muscle troponin activator and is the lead drug candidate from the company's skeletal sarcomere activator program. CK-2017357 selectively activates the fast skeletal troponin complex and increases its sensitivity to calcium, leading to an increase in skeletal muscle force.
"With the initiation of our second Phase I clinical trial and Part B of our ongoing Phase I trial, we expect to gain additional insights into the pharmacokinetics of this novel mechanism drug candidate in healthy volunteers. In addition, we hope to begin to understand the impact this fast skeletal muscle troponin activator may have on the relationship between the force produced by a skeletal muscle and the frequency with which it is stimulated by the motor nerve supplying it, or more simply, the force-frequency relationship," stated Andrew A. Wolff, MD, FACC, Cytokinetics' Senior Vice President of Clinical Research and Development and Chief Medical Officer. "Observations from both of these clinical trials will inform our decisions regarding other metrics to assess in patient populations we intend to study in our Evidence of Effect clinical trials planned for 2010."
{tiny;CGEN;1}In Israel, Compugen Ltd. (NASDAQ:CGEN) announced today the discovery and experimental confirmation of a genetic biomarker, CGEN-40001 for predisposition to type 2 diabetes, the most common form of diabetes. This new biomarker was discovered using Compugen’s GeneVa® platform, which consists of an in silico database of approximately 350,000 predicted genetic variations in the human genome, with each predicted variation consisting of multiple consecutive nucleotides.
There are an estimated 24 million people in the U.S. with diabetes, 90% of whom are affected by type 2 diabetes.
Predisposition markers are of particular value in diseases like type 2 diabetes, where specific lifestyle and health factors are known to play an important role. Following diagnosis, high-risk patients may benefit from more aggressive management either through lifestyle modification or drug treatment.
During the past few years, extensive efforts by others searching for genetic markers for type 2 diabetes have utilized numerous genome-wide association studies, involving thousands of patients globally. Several validated genetic markers have been found; however, combining all the discovered biomarkers still explains only a small fraction of the heritability of the disease, so the need for additional markers continues to exist.
{tiny;ANSV;3}Anesiva, Inc. (Nasdaq: ANSV) says it got good news from the NASDAQ Stock Market. The letter states that the Nasdaq Hearing Panel has granted Anesiva's request for continued listing on The NASDAQ Global Market subject to the condition that Anesiva shall have completed on or before December 31, 2009, the proposed merger (the "Merger") contemplated by the Agreement and Plan of Merger, dated August 4, 2009, among Anesiva, Arca Acquisition Corporation ("Arca"), a wholly-owned subsidiary of Anesiva, Arcion Therapeutics, Inc. ("Arcion") and, with respect to Articles V and IX only of the agreement, each of the Arcion stockholders listed on Schedule I thereto.
On September 24, 2009, the company had received a letter from NASDAQ, stating that the minimum closing bid price of Anesiva's common stock was below $1.00 per share for 30 consecutive business days and that therefore Anesiva was not in compliance with Listing Rule 5450(a)(1). The letter stated that Anesiva would be afforded 180 calendar days, or until March 16, 2010, to regain compliance with the minimum closing bid price requirement.
Anesiva is looking to become a leader in the development and commercialization of novel pharmaceutical products for pain management. Anesiva's lead product candidate is Adlea, a novel small molecule formulation of capsaicin that is currently in development for management of both acute and chronic pain. Adlea has been shown in clinical trials to provide extended pain relief after only a single administration in a variety of localized moderate-to-severe pain conditions.
