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Tekmira Offers Details on Timing of RNAi Drug Programs, Aims to Enter Clinic in 2009

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Less than two months after merging with its one-time subsidiary Protiva Biotherapeutics, Tekmira Pharmaceuticals this week confirmed that it would move two RNAi-based drug candidates — one for hypercholesterolemia and one for cancer — into phase I trials next year.
 
In April, Tekmira and Protiva said terms of the merger would end all the litigation between them over ownership of Protiva’s core stable nucleic acid lipid particle, or SNALP, delivery technology (see RNAi News, 4/3/2008).
At the time, the companies said that the combined firm would advance the two investigational RNAi drugs into human testing in 2009.
 
According to Tekmira, the cholesterol drug, called SNALP ApoB, is slated to enter a phase I study in the first half of next year. The drug targets apolipoprotein B, a protein involved in cholesterol metabolism. The second drug, called SNALP PLK1, targets polo-like kinase 1, a gene linked to the growth of certain solid tumors, and is expected to enter phase I testing in the second half of 2009.
 
Tekmira’s partner Alnylam Pharmaceuticals holds an option to co-develop and co-market SNALP PLK1, although that option expires at the commencement of phase II trials.
 
"Following the close of the business combination between Tekmira and Protiva, we committed to taking a close look at the new company's combined product portfolio and future milestones,” Tekmira President and CEO Mark Murray said in a statement. “We are now moving forward with a clear two-part strategy [that includes focusing] on developing products exclusively in the RNA interference (RNAi) therapeutics field with our two lead product candidates, ApoB and PLK1, and [supporting] our partners as they advance products based on our leading delivery technology."
 
Currently, Merck, Alnylam, and Roche hold licenses to use Tekmira’s SNALP technology for certain RNAi drug programs.
Murray was not available for additional comment.
 
With the addition of SNALP ApoB and SNALP PLK1 to Tekmira’s formal drug-development pipeline, the number of investigational RNAi therapeutics has grown a little bigger. To provide a snapshot of the state of RNAi drug development, RNAi News has compiled a list of key RNAi drug programs.
 
 
RNAi Therapeutics Pipelines
Company Drug Name, Indication Status
Allergan AGN-745, wet age-related macular degeneration (licensed from Sirna Therapeutics) Phase II
Alnylam Pharmaceuticals ALN-RSV01, respiratory syncytial virus Phase II in adult lung transplant patients infected with RSV; second phase II in pediatric populate slated for second half 2008
Hypercholesterolemia Preclinical, possible IND filing in 2008
ALN-VSP01, liver cancer Preclinical, possible IND filing in 2008
ALN-HTT, Huntington's disease (in collaboration with Medtronic) Preclinical
Progressive multifocal leukoencephalopathy (in collaboration with Biogen Idec) Preclinical
Pandemic influenza (in collaboration with Novartis) Preclinical, on hold
Calando Pharmaceuticals CALAA-01, solid tumors Phase I
Cequent Pharmaceuticals CEQ501, familial adenomatous polyposis IND planned for 2009
CEQ400, human papillomavirus Preclinical, possible IND filing in 2009
CEQ600, inflammatory bowel disease (Novartis holds option on drug) Preclinical, possible IND filing in 2009
Dicerna Pharmaceuticals Hepatitis C Preclinical
Solid tumors Preclinical
Type II diabetes Preclinical
Hyperlipidemia Preclinical
Intradigm ICS-283, cancer Possible IND in 2008
Merck* Unknown Unknown
MDRNA
(formerly Nastech Pharmaceutical)
Rheumatoid arthritis Preclinical
Influenza Preclinical
Opko Health Bevasiranib, AMD Phase III
Pfizer RTP801i-14, AMD (licensed from Quark) Phase I
RXi Pharmaceuticals Amyotrophic lateral sclerosis Preclinical
Obesity/type II diabetes Preclinical
Cancer Preclinical
Silence Therapeutics Atu-027, gastrointestinal cancer (possibly lung cancer) Possible phase I in 2008
Atu111, prostate cancer Preclinical
Atu150, liver cancer Preclinical
Sirnaomics STP-601, ocular neovascularization diseases including AMD Phase I planned for 2008
STP-705, wound healing IND planned for late 2009
STP-503, solid tumors IND planned for late 2009
STP-801, solid organ transplantation Preclinical
STP-702, pandemic influenza Preclinical
Tacere Therapeutics TT-033, hepatitis C (in collaboration with Pfizer) IND planned for 2009
Tekmira Pharmaceuticals ApoB SNALP, hypercholesterolemia Phase I planned for first half of 2009
PLK1 SNALP Phase I planned for second half of 2009
Quark Pharmaceuticals AKIi-5, acute kidney failure Phase I
DGFi, delayed graft function IND approved, phase I pending
IGNi, glaucoma Preclinical
AHLi-11, acute hearing loss Preclinical
CTi-1, chronic obstructive pulmonary disease Preclinical
PAb-W4, chronic renal failure Preclinical

* Editor's note: Following its acquisition of Sirna Therapeutics, Merck has not disclosed the status of any of Sirna's drug-development efforts, which had included ones in hepatitis C and cancer, as well as efforts in respiratory disease in collaboration with GlaxoSmithKline.

Merck did announce earlier this year that it had handed off the full rights to Sirna's preclinical Huntington's disease to partner Targeted Genetics Targeted Genetics (see RNAi News, 4/10/2008). As reported by RNAi News, Merck also quietly shut down Sirna's dermatology unit, which had been developing an RNAi-based drug for permanent hair removal (see RNAi News, 1/24/2008).

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