Tekmira Presents Positive Interim Results on Phase I/II Clinical Programs
News May 23, 2014
Tekmira Pharmaceuticals Corporation has announced that recent advances in its clinical programs were presented at the 17th Annual Meeting of the American Society of Gene and Cell Therapy, which is taking place in Washington, DC, May 21 to 24.
"Today, Dr. Ian MacLachlan presented positive clinical data which further validates our LNP technology and demonstrates progress within both our anti-viral and oncology programs. The TKM-Ebola phase I trial results are significant as they establish the safety of 'third generation' LNP formulations and confirm that dosing at efficacious levels may be accomplished without the need for pre-medication. We are encouraged by these technology advances and they will support the development of Tekmira's other anti-viral therapeutics," said Dr. Mark J. Murray, Tekmira's President and CEO.
The presentation titled "Progress in the Development of Lipid Nanoparticle-RNA Therapeutics" was delivered by Tekmira's Chief Technical Officer, Dr. Ian MacLachlan. During the presentation, Dr. MacLachlan shared new interim data from the ongoing TKM-Ebola Phase I Clinical Trial and the Phase I/II Clinical Trial with TKM-PLK1.
Some key summary points from the presentation include:
• Tekmira has successfully completed the single ascending dose portion of the TKM-Ebola Phase I Clinical Trial in healthy human volunteers.
• Results demonstrate that administration of the TKM-Ebola therapeutic, in the absence of any steroid containing pre-medication, was well-tolerated at a dose level of 0.3 mg/kg.
• TKM-Ebola drug exposure levels achieved in these subjects demonstrate that the multiple ascending dose portion of the trial will achieve drug exposure levels previously shown to confer complete protection in non-human primates exposed to a lethal Ebola virus inoculum.
• Both the safety profile and pharmacokinetics observed in the single dose portion of the trial support initiation of the multiple ascending dose portion of the study.
• Tekmira previously disclosed (October 2013) three of four Adrenocortical Carcinoma (ACC) patients participating in the company's ongoing GI-NET/ACC trial had achieved stable disease.
• One of these patients is continuing on therapy and has achieved a RECIST qualifying Partial Response (PR), defined as > 30% reduction in target tumor lesions.
• This patient with the PR has been on TKM-PLK for 12 months and has experienced a 44% reduction in their target tumor mass, located outside of the liver. Furthermore, scans of the target tumor lesions demonstrate signs of necrosis, indicative of anti-tumor activity.