dm+d

Unassigned

New Medicines

CollategeneCritical limb ischaemia to improve ulcers in patients suffering from chronic arterial occlusion (arteriosclerosis obliterans and Buerger ’s disease)

Information

Collategene
New molecular entity
AnGes
Anges

Development and Regulatory status

None
None
Phase II Clinical Trials
Nov 20AnGes is progressing development of Collategene for arteriosclerosis obliterans with lower limb ischaemic ulcers in several markets. In the US, it has an agreement with Mitsubishi Tanabe Pharma; in Turkey, it has partnered with Er-Kim and is preparing to file; and in Israel it is collaborating with Kamada, where it is also preparing to submit a licence application. No plans announced re European/UK development but AnGes is aiming to become a global leader in gene medicine [10].
Mar 19Approved in Japan and a commercialisation partner found for Israel [9]
Nov 18Development appears to concentrating on the Japanese market. [8]
Nov 17A long-term follow-up observational trial to assess the safety in patients with critical limb ischaemia (NCT02974179) is currently recruiting by invitation only, in the US [7]
Jun 16a new PIII study with amended endpoints and US-only recruitment will be discussed with the FDA following termination of the existing PIII trial, in order to maintain the planned development timing within available finances. Japanese development, which is separate, is unaffected [6].
Oct 14Following initial of a P3 study, submission of the Biologics License Application is targeted for as early as 2018 in the US, with applications in Europe to follow. [4]
Oct 12AnGes has reached agreement with the FDA on a SPA (Special Protocol Assessment) for a PIII global clinical trial and obtained Fast Track Drug Development Programme status [3].
Jan 10In March 2008, AnGes submitted the drug for marketing approval to Japanese regulators and is still awaiting approval [1].
Jan 10A PII trial started in the US in April 2003 [1]

Category

Hepatocyte growth factor gene therapy; naked plasmid DNA (not using a virus vector)
Critical Limb Ischemia is a condition of peripheral arterial disease where severely reduced blood flow to the legs develops severe pain, ulcers or necrosis, and amputation of the limb may be unavoidable. There is no effective medicine for patients who are not suitable for current treatments such as endovascular interventions or vascular bypass surgery. When injected into a patients muscle, Collategene is considered to form new blood vessels and improve blood flow to the affected limb [4]
Critical limb ischaemia to improve ulcers in patients suffering from chronic arterial occlusion (arteriosclerosis obliterans and Buerger ’s disease)
Intramuscular

Trial or other data

Nov 20PII trial to assess the safety and efficacy of intramuscular injection of AMG0001 (hepatocyte growth factor [HGF] plasmid) to improve ulcer healing and perfusion in patients with peripheral artery disease is recruiting in the US (no UK sites) (NCT04267640). The study began in Jan 20 and the primary outcome is complete ulcer healing at 6 months and time to complete ulcer healing at 12 months; collection of these data is expected to complete Jul 22 [11].
Jun 16The NCT02144610 PIII trial has been terminated due to slow recruitment [6].
Oct 15The randomised, double-blind, placebo-controlled phase III trial (NCT02144610) in patients with critical limb ischaemia is currently recruiting pts, with the first patient dosed in Aug 2015. The estimated final data collection date for the primary outcome measure is Feb 2019. Data from the trial will support regulatory filings in the US and Europe [5].
Oct 14PIII study commenced to assess safety and efficacy of Collategene in approximately 500 subjects with critical limb ischaemia. [4]
Oct 12AnGes has entered into an agreement with Mitsubishi Tanabe for the exclusive marketing rights of Collategene in the US [3].
Jan 10Vical report that its Japanese partner AnGes MG has received a Special Protocol Assessment approval from the FDA for a global PIII study. The study will have a target population of 560 patients and will enroll ‘no option’ as well as ‘poor option’ high risk patients (eligible for revascularisation surgery) with chronic and severe ischaemia of the lower limb. In addition, AnGes intends to submit the PIII trial design to Canadian, European and Latin American regulators [2].
Jan 10Interim analysis from a PIII study showed HGF gene therapy (8mg) improved rest pain (VAS) or ischaemic ulcer size at 12 weeks post dosing by 70.4% vs 30.8% with placebo, in 40 patients with critical limb ischaemia [1].
Jan 10Collategene uses Vical´s technology to deliver a human protein that causes growth of blood vessels when injected in areas of restricted blood flow [1].