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Sirnaomics Starts Setting Up Chinese Unit, Aims for Up to Three Clinical Trials in 2009

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Sirnaomics has begun setting up a corporate entity in China in order to take advantage of the nation’s low-cost labor and research materials, as well as the technical expertise of its research institutions, RNAi News has learned.
 
Sirnaomics President and CEO Patrick Lu said he views China, especially the Shanghai area where the business unit is located, as becoming “the leading biomedical research and marketing center of Asia. We want to have a foothold [there] … and build an entity as the leader in Asia for siRNA therapeutics.”
 
At the same time, Gaithersburg, Md.-based Sirnaomics is pushing forward its lead drug-development program, a multi-siRNA cocktail for ocular diseases characterized by subfoveal choroidal neovascularization called STP-601, which it expects to enter a phase I trial in the first quarter of 2009. The company had previously been planning to launch the study before the end of this year (see RNAi News, 3/13/2008).
 
Lu said the company has completed a pre-investigational new drug application meeting with the US Food and Drug Administration and received “very good feedback” from the agency. “Basically, we have a green light to move forward with IND-enabling studies,” he told RNAi News this week.
 
Elsewhere in Sirnaomics’ pipeline, a relatively new effort in pandemic influenza being conducted with researchers at the University of Hong Kong has yielded “pretty substantial” preclinical efficacy data, Lu said.
 
“We are ready to move to the next stage of development … [and] hope we can get into the clinic sometime around the middle of next year,” he added.
 
China Syndrome
 
Commenting on Sirnaomics’ expansion into China, the company’s vice president of discovery research Dave Evans said that there are “tremendous local universities” in and around Suzhou, the city where the new entity is officially located, and that the company has identified a “very strong scientific group that’s going to be coming onboard.”
 
Lu noted that Sirnaomics has yet to finalize the exact structure of its “Chinese counterpart” and he declined to specify how many people the entity will employ. Sirnaomcs currently employs about a dozen people.
 

“China, [especially in] the Shanghai area, we see [as becoming] the leading biomedical research and marketing center of Asia. We want to have a foothold [there] … and build an entity as the leader in Asia for siRNA therapeutics.”

Further driving Sirnaomics expansion into Asia is the fact that the cost of labor, research reagents, and other resources is “significantly lower” in China, Evans said. As such, the company will be able to do “a lot of routine experimental work [under] more economically favorable” conditions.
 
“For us, if we want to push multiple therapeutic programs forward, the preclinical studies become a very sizable hurdle” given the expense associated with such work, Lu added. “Taking advantage of the low costs for IND-enabling preclinical studies can be a money-saving practice.”
 
Further cost savings are expected should Sirnaomics follow through on plans to conduct some of its clinical studies in China.
 
“With a large population over there, you play statistics games” when it comes to recruiting clinical study participants, Evans said. “You may have a small percentage of people with a particular disease, but that translates into a large number of people” in China, considering the country’s population, which currently stands at about 1.3 billion.
 
While Sirnaomics currently expects that its phase I trial of STP-601 will be conducted in the US, it appears to be only a matter of time before the company will be able to benefit from its Chinese presence when it comes to enrolling patients in clinical studies.
 
Lu said that it is “very likely” that phase II and phase III studies of STP-601 will be held in China.
 
“In the US, if you talk to eye doctors, you question how fast you can really recruit 300 patients,” he said. “You have a better chance of recruiting a sufficient patient population quickly” in China.
 
Still, questions remain as to whether Sirnaomics will ultimately have to repeat all or some of its clinical work if it wants to get its drugs onto the US market since it is not clear how the FDA will view clinical data from Chinese studies.
 
“There is some precedent for other drugs, but we cannot say what’s going to happen,” Lu said.
 
Pipeline Plays
 
Though it is not as advanced as STP-601, Sirnaomics’ pandemic flu drug has quickly jumped ahead of other compounds in the company’s pipeline.
 
Dubbed STP-702, the drug is being developed as a treatment for seasonal and pandemic flu, and it targets multiple, undisclosed viral genes using a proprietary nanoparticle-based delivery system.
 
When administered intranasally in a mouse model, the compound demonstrated both therapeutic and prophylactic potency against the H5N1 strain of avian influenza, according to Sirnaomics.
 
With these data in hand, Sirnaomics said it has applied for a $7 million cooperative agreement research grant from the National Institute of Allergy and Infectious Diseases to help it further develop the flu drug and other siRNA-based treatments for respiratory viral infections.
 
The company also said that it has submitted a proposal seeking around $11 million for the development of its siRNA drug-development platform for biodefense applications. According to Sirnaomics, the platform includes a proprietary algorithm for siRNA sequence prediction against specific targets, robotic screening technology for sequence validation, and nanoparticle delivery technologies.
 
While development of Sirnaomics’ ocular disease and flu drug candidates continues, the company is also working on a number of other therapies including STP-705, which is being developed in collaboration with General Research Laboratory.
 
STP-705 “has progressed quite well … [and] the data is very exciting,” Lu said. “We hope that by the end of next year we can move this into the clinic … [using] a clinically accepted delivery system” that incorporates Sirnaomics’ proprietary nanoparticle delivery technology.”
 
The company is also developing a treatment for solid tumors called STP-503 with GRL and a drug to improve patient outcomes after solid organ transplantation. Lu declined to provide specific details on the drugs.

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