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Atugen Gives Update on Cancer Drugs; Firm Aims To Be First in Clinic as Phase I Is Set for 1H 2007

SR Pharma subsidiary Atugen last week gave an update on its drug pipeline, stating that it plans to begin phase I testing of its pancreatic cancer drug Atu-027 in the first half of 2007, followed by a phase I study of an RNAi drug for lung cancer in the second half of the year.
With human studies expected to begin shortly thereafter, Berlin-based Atugen is on track to be the first company to test an RNAi-based therapy for cancer in the clinic. Other firms eyeing the RNAi-for-oncology field are Calando Pharmaceuticals (see RNAi News, 10/26/2006), Abbott (see RNAi News, 7/6/2006), and siRNAsense (see RNAi News, 5/25/2006).
Speaking at the Discovery on Target 2006 meeting in Boston late last month, Atugen CSO Klaus Giese also noted that the company has finished producing Atu-027 for the clinical trial and that it plans to start testing the drug in non-human primates in a few months.
“The non-human primates are ordered, [and] they are getting trained for continuous infusion experiments,” Giese told RNAi News this week. He added that the firm is scheduled to begin these dose range-finding experiments in January.
Atu-027 incorporates Atugen’s proprietary siRNAs, which are 19-mer duplexes that lack 3' overhangs and have been chemically stabilized with alternating 2'-O-methyl sugar modifications on both strands, with its so-called lipoplex technology comprising a mixture of cationic and fusogenic lipids.
Atu-027 is designed to inhibit the growth of new blood vessels feeding tumors — an approach being explored by numerous drug makers with a variety of different therapeutic modalities — by targeting PKN-3.
In 2004, Atugen researchers published data in The EMBO Journal showing that PKN-3 is “a novel effector mediating malignant cell growth downstream of activated PI3K,” which is associated with metastatic cell growth. 
Earlier this year, Atugen researchers published data in Gene Therapy showing that its blunt-ended siRNAs can trigger an RNAi effect in the vasculature of mice when delivered using the lipoplex technology (see RNAi News, 4/27/2006). The researchers showed that the company's formulated siRNAs could be used to inhibit tumor growth and metastases in xenograft mouse models, apparently through anti-angiogenesis, by targeting CD31.
Follow-on work in rodent cancer models demonstrated that Atu-027 could inhibit tumor cell growth and proliferation with no adverse effects. With these data in hand, Atugen is now aiming to see if a similar effect can be seen in humans.
According to Giese, the phase I study of Atu-027 will be conducted in treatment-naive pancreatic cancer patients at the Charite Hospital, Berlin. Trial participants will be treated with both the RNAi drug and Eli Lilly’s Gemzar (gemcitabine), the current standard of care.
“This [study] will probably take a year because the incidence of pancreatic tumor is not that high,” Giese said, adding that the company expects to run a separate phase I trial evaluating the safety of Atu-027 in patients with various gastrointestinal cancers who have previously received treatment.

“The non-human primates are ordered, [and] they are getting trained for continuous infusion experiments.”

At the Discovery on Target 2006 meeting, Giese also said that Atugen had plans to begin a phase I study of another of its RNAi drugs, called Atu-093, in non-small cell lung cancer during the second half of 2006. He did not, however, present any preclinical data for the therapeutic candidate.
He told RNAi News this week that although Atu-093 is next in the company’s pipeline to move into human trials, it might not do so if Atu-027 shows efficacy in humans.
If Atu-027 “looks good [in humans], we’ll most probably perform the lung cancer [trial] with the same drug,” he said. A decision, he noted, will be made while phase I testing of the pancreatic cancer drug is ongoing.
While in the US to present at Discovery on Target 2006, Giese said he is also meeting with potential pharma/biotech partners as Atugen moves toward meeting its previously stated goal of striking at least one “significant” collaboration for one of its RNAi programs during 2006.
“We have a couple of hot leads,” he said. And while the company expects to meet its timeline, he added that “if it’s big pharma, it might take a little bit longer” than before the end of the year.
Giese said that while Atugen is interested in collaborating on Atu-027, the company is “open” to partnering elsewhere in its pipeline, which includes research-stage programs in prostate and liver cancer.
Additionally, he said that the company is looking to form alliances that would take advantage of its work developing spray-dried formulations of its modified siRNAs, which would enable delivery via inhalation for indications such as asthma and chronic obstructive pulmonary disease.
Giese added that Atugen also continues to pursue its goal of acquiring a product or company within 2006.
“We still have another two months,” he said.

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