dm+d

Unassigned

New Medicines

GenerxMyocardial ischaemia and refractory angina due to advanced coronary artery disease

Information

Generx
New molecular entity
Angionetics
Angionetics

Development and Regulatory status

None
None
Phase III Clinical Trials
Dec 19No recent reports of development in EU, latin America or canada. NCT01550614 terminated Jun 2016 [18]
Dec 15Phase III ASPIRE study is still recruiting subjects [10].
Apr 15Taxus Cardium spins off Angionetics as a majority-owned subsidiary to develop and commercialise Generx, with 15% of shares held by a Chinese company, Shenzhen Qianhai Taxus Industry Capital Management [13].
Mar 15NCT01550614 (ASPIRE) due to complete Jul 16 [7]
Mar 14Interim analysis of PIII registrational ASPIRE study anticipated mid-2014. [6]
Jul 07Alferminogene tadenovec receives fast track designation for myocardial ischaemia from the US FDA (4).
May 07PIII trials begin in US (4).
Oct 05PII/III trials for myocardial ischaemia begin in US and Europe (4).

Category

DNA based biological to promote angiogenesis, one-time intracoronary infusion (6x10e9 viral particles in buffer)
The ASPIRE trial included patients with extensive CA disease, or high risk patients or those not suitable for further surgery.
Myocardial ischaemia and refractory angina due to advanced coronary artery disease
Intracoronary

Trial or other data

Aug 20PIII AFFIRM study (NCT02928094) is now expected to start recruiting in Jun 21. 160 adults aged 55 to 75 years will be enrolled (sites not yet stated). Collection of ETT primary outcome data is expected to complete in Jun 22. Angionetics is the sponsor and Huapont Life Sciences a collaborator. Under the terms of their agreement, Angionetic is responsible for the planned US based PIII clinical programme, while the Huapont affiliated entity will be responsible for clinical development, registration and marketing of the drug in China [18,19].
Jun 20Trial registry entry not updated since Jul 19 [17].
Jul 19AFFIRM study (NCT02928094), recruitment not started. No trial sites stated [17].
Oct 18PIII AFFIRM study is still not yet recruiting subjects – the estimated primary completion date has been amended to June 2021 [16].
Jan 18PIII AFFIRM study not yet recruiting patients [15].
Oct 16AFFIRM study (NCT02928094) will be a randomised, double-blind, placebo-controlled trial (estimated n=320); primary outcome is change in exercise tolerance test (ETT) duration from baseline to six months. Estimated start date is Sept 2017 and estimated primary completion date Sept 2019 [14].
Sep 16PIII AFIRM study initiated [12]
Jun 16PIII ASPIRE study terminated [11]
May 15A pooled analysis of interim data from ASPIRE and AGENT trials demonstrated an improvement of 25%, in reversible perfusion defect size, in patients treated with alferminogene tadenovec compared with patients treated with the control (p = 0.005; n = 63) [9].
Mar 15ASPIRE will have enrolled around 780 patients in the US, Canada, South America, Western Europe and Russia and will support submissions for marketing [8]
Mar 12The initiation of the ASPIRE Phase 3 registration study has been announced; a 100 pt, multi-centre RCT conducted at up to six leading cardiology centers in the Russian Federation. Pts with myocardial ischemia due to coronary artery disease will be recruited and the primary efficacy endpoint of the study will be the improvement in reversible perfusion defect size as measured by SPECT myocardial perfusion imaging both at rest and under cardiovascular stress (5).
Feb 12AGENT3 & AGENT4 studies in women showed improvement in ischaemia and overall exercise tolerance (1). Phase III AWARE (Angiogenesis in Women with Angina pectoris who are not candidates for Revascularisation) RCT (n~300 women with recurrent stable angina pectoris who are not candidates for revascularisation and who are receiving optimal treatment). Primary endpoint = improvement in time to onset of ECG changes diagnostic of myocardial ischemia during exercise treadmill testing at six months. (2)