Tekmira Pharmaceuticals Corp. (TSX: TKM) has filed with U.S. regulators for approval to enter into clinical trials with a new treatment for solid cancer tumours.
If Tekmira’s investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) receives approval, the Burnaby-based firm will have formally added a second drug to its internal pipeline.
The firm’s new drug, known as PLK1 SNALP, targets polo-like kinase 1, a protein involved in tumour cell growth.
According to Tekmira, PLK1 SNALP displayed potent anti-tumour effects in preclinical trials involving a variety of tumour models in animals.
The FDA has 30 days to review Tekmira’s IND application and request any additional information before approving clinical trials.
Tekmira expects to enter trials with the drug in the second half of 2010.
Tekmira’s drugs are known as RNAi therapeutics, which have been shown to have the ability to silence disease-causing genes.
For example, Tekmira’s lead product, ApoB SNALP, is being developed to silence a protein that causes the body to produce too much cholesterol.
Aside from its two lead candidates, Tekmira is supporting the development of numerous drugs in trial programs led by Tekmira’s partners.
Mark Murray, Tekmira’s president and CEO said: “Between Tekmira’s clinical programs and those of our partners Alnylam and Roche, we forecast there will be five or six development programs deploying Tekmira’s technology by year-end.”
He said that there are hundreds of thousands of solid tumour cases in North America every year. Such tumours do not contain liquid or cysts within them.
The company also owns an encapsulation and delivery technology, known as SNALP, which protects and helps deliver highly unstable RNAi therapeutics as they make their way to a target destination in the body.
The company’s most recent milestone came on July 15 when it signed a contract worth as much as US$140 million to develop a treatment for the deadly Ebola virus for the U.S. government. (See “Tekmira signs $140m contract with U.S. defence department ” – BIV Daily edition; July 16)
Tekmira's share price range during the last week: $1.62 to $1.65; 52-week high: $1.95; 52-week low: $0.69.