Roughly three months after officially opening its Chinese subsidiary, Sirnaomics is weighing the possibility of conducting its first clinical trial, a phase I study of the ocular disease drug STP-601, in nearby Hong Kong.
Although it had originally expected to conduct the study in China, the company later decided to do so in the US in light of Chinese regulators' unfamiliarity with RNAi technology and concerns over whether the US Food and Drug Administration would accept the data.
And while a US trial is still an option, the company is now also considering running the study in Hong Kong, a special administrative region under Chinese control that Sirnaomics President and CEO Patrick Lu classifies as a sort of regulatory middle ground between the US and China.
Currently, the US Food and Drug Administration will allow a company to perform clinical studies of a drug in Hong Kong once the agency has approved the relevant investigational new drug application, Lu says. At the same time, Chinese regulators will accept data from trials conducted in Hong Kong.
Sirnaomics does envision a time when it could run trials in China and use the resulting data in FDA regulatory packages, but just when this may happen is uncertain.
Lu says that there is precedent for including Chinese data in a US new drug application, pointing to Bayer's recently approved cancer drug Nexavar, which was evaluated in a phase III study that -included sites in China, Korea, and Taiwan. But whether the FDA will accept data from trials run only in China, however, is not known, he adds.
In the end, Lu says Sirnaomics primarily will consider "speed and cost" in deciding whether to conduct a phase I study of STP-601 in the US or Hong Kong. However, the company does not want to unnecessarily rush things since the trial will act as a kind of "pilot study to find out the best way to go ahead with other -candidates," Lu says.
"That's why we're carefully evaluating the best scenario for us in the long run," he says.
—Doug Macron
RNAi Notes
Isis Pharmaceuticals began a phase I study of an antisense-based drug for type II diabetes. The drug, ISIS-SGLT2Rx, is designed to inhibit the production of sodium dependent glucose co-transporter type 2, which is the major transporter responsible for glucose re-absorption in the kidney.
Champions Biotechnology is collaborating with Gradalis and the Mary Crowley Cancer Research Center to develop personalized vaccines for cancer patients, derived from the patients' own tumors.
Mirna Therapeutics teamed up with the University of California, San Francisco, to study whether certain micro-RNAs reduce or eliminate tumors in mouse models of cancer.
Datapoint
$25 million
Amount that RXi Pharmaceuticals will receive from YA Global Investments.
Funded Grants
$282,600/FY 2009
Double-stranded RNA-mediated signaling pathway and gene silencing
Grantee: Yi Liu, University of Texas Southwest
Medical Center, Dallas
Began: Sept. 16, 2008; Ends: Aug 31, 2010
With these funds, Liu will determine the signaling -pathway behind dsRNA-induced gene transcription in the filamentous fungus Neurospora crassa. He also will look into the biogenesis and function of DNA damage-induced small RNAs and their role in maintaining genome stability.
$474,750/FY 2009
MicroRNA regulation of human T and B cell activation
Grantee: Daniel Rene Salomon, Scripps Research Institute
Began: Feb. 15, 2009; Ends: Jan. 31, 2014
Salomon will analyze miRNA expression during the activation of human T and B cells as well as determine if post-transcriptional processing of miRNA precursors in the nucleus plays an important role in activation. He will use tandem mass spectrometry proteomics and next-generation sequencing to see if protein, mRNA, and miRNA expression are linked with network regulation.