Quark IND for Kidney Transplant Drug Gets FDA OK
Quark Pharmaceuticals this week said that the US Food and Drug Administration has approved the company’s investigational new drug application for DGFi, an siRNA designed to prevent and/or treat delayed graft function in kidney transplant patients.
The approval clears Quark to begin a planned phase I/II trial for the drug. According to the company, the study will evaluate DGFi as a single intravenous injection in 204 renal transplant patients with DGF.
DGF is a syndrome triggered by ischemia and reperfusion injury, said Quark. DGFi is designed to inhibit expression of the transcription factor human p53, which is associated with DNA repair and apoptosis.
The company is currently testing a similar siRNA-based drug, AKIi-5, in a phase I/IIa study as a preventative of acute kidney injury following major cardiac surgery (see RNAi News, 11/22/2007).
Rosetta Inks miRNA Dx Collaboration with Rabin Medical Center
Rosetta Genomics said this week that it has formed a collaboration with the Rabin Medical Center in Israel to develop microRNA-based diagnostics for indications in oncology, gynecology, and obstetrics.
The company said that the initial focus of the alliance is women’s health.
Additional terms of the arrangement were not disclosed.
Rosetta is currently developing three diagnostics based on miRNAs: a test for differentiating squamous from non-squamous non-small cell lung cancer that is expected to hit the US market this year, as well as ones for determining the source of cancers of unknown primary origin and differentiating lung adenocarcinoma from mesothelioma.
Last week, Rosetta said that it had moved three new tests into its diagnostic pipeline including one for predicting response to ovarian cancer treatment, one for gauging the risk of gastric cancer recurrence, and one for differentiating small from non-small cell lung cancer (see RNAi News, 6/19/2008).
RXi Inks Deals to Sell $8.7M in Stock to Institutional Investors
RXi Pharmaceuticals said this week that it has entered into definitive agreements with institutional investors to sell around 1.1 million shares of its common stock at $8.12 per share for gross proceeds of $8.7 million.
The company said it will use the proceeds of the private placement for working capital and other general corporate purposes.