RNA interference (RNAi)-based drug development company Quark Pharmaceuticals Ltd. has reported that it has completed recruitment for its Phase II clinical trial of RTP-801i, its treatment for diabetes macular edema. Quark is developing the drug with Pfizer Inc. (NYSE: PFE; LSE: PFZ), which has the marketing license to the drug.
Pfizer is conducting its own Phase II clinical trial of RTP-801i for age-related macular degeneration (AMD). It purchased the rights for the drug for this purpose from Quark as part of the same licensing agreement.
Quark has also completed patient recruitment for two studies that it is conducting independently. One study is a Phase I clinical trial of its drug for the prevention of acute kidney injury following heart surgery. The second study is a Phase I/II trial of drug candidate QPI-1002 for the prevention of damage to kidney transplants,when the functioning of the new organ is delayed.
Quark hopes that, during the first quarter of 2010, it will begin recruiting patients for an independent study of drug candidate QPI-1007 for protecting nerve cells in the eye from degenerative diseases, such as glaucoma.
Quark founder and CEO Dr. Daniel Zurr said, "Over the next 15 months, at least one of our programs should enter a Phase III trial. We are currently undertaking four trials under US Food and Drug Administration (FDA) Investigational New Drug (IND) guidelines, and a fifth trial is slated to begin shortly."
Quark's drugs are based on new mechanisms for drug discovery. The company has developed a technique for investigating the effects of various genes on a range of illnesses by selectively silencing the genes. Both AKLi-5 and RTP-801i are silencing RNA (siRNA) drugs that temporarily inhibit the expression of human p53. The company currently only has Phase I trial results for RTP-801i for AMD, and the treatment was found to be safe.
In 2006, Quark raised tens of millions of dollars in a round led by Japanese funds. It signed the strategic agreement with Pfizer in the same year, under which the company transferred to Pfizer several molecules under development. Pfizer invested tens of millions of dollars in Quark at the time of the agreement, and Quark's income from the agreement could reach hundreds of millions of dollars in the long term if the drugs reach market.
In early 2007, Quark planned to hold an IPO on Nasdaq on the basis of the Pfizer agreement. The company planned to raise $75 million at a company value of $250-300 million, but withdrew the offering when the market rejected the valuation.
The present announcement may be a feeler aimed at testing a new Nasdaq IPO, now that Quark has several products in the pipeline.
Published by Globes [online], Israel business news - www.globes-online.com - on December 2, 2009
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