Good progress with partnerships and additional clinical studies commenced
Guildford, UK: Ergomed plc, (LSE: ERGO) a profitable UK-based company dedicated to the provision of specialised services to the pharmaceutical industry and the development of new drugs, provides an update on its four current co-development partnerships. All the partners have studies that are in late stage development with the potential to deliver significant phase II and Phase III news flow in the next two years.
Ergomed has three partnerships with US listed companies that are developing phase III oncology drugs and a fourth agreement with a European company that is about to start a Phase II study in insomnia. Under these agreements, Ergomed is contributing to the cost of the clinical trials and in return will receive a share of any proceeds generated from the commercialisation of the partnered drug asset.
CEL-SCI (NYSE MKT: CVM): Ergomed is working with CEL-SCI on the largest ever Phase III study in head and neck cancer with lead product Multikine. The trial will enrol approx. 880 patients with advanced primary head and neck cancer. CEL-SCI recently announced that a total of 252 patients had been enrolled, representing over one-quarter of the total enrolment for the study. Four clinical sites in the U.S. have been added and the trial is currently being expanded into the UK, Austria, Sri Lanka, Turkey and France.
Ergomed and CEL-SCI have also agreed to commence Phase I studies in the additional indication of peri-anal warts in HIV/HPV co-infected patients and have commenced planning for a Phase II study in cervical dysplasia in HIV/HPV co-infected patients. Geert Kersten, CEO of CEL-SCI, calls Ergomed his "internal" clinical development group.
Synta Pharmaceuticals (NASDAQ:SNTA): Ergomed has a co-development partnership on Synta's lead development candidate, ganetespib, which is in clinical studies for a number of cancer indications.
Since the beginning of 2014, several important clinical milestones have been reached in the ganetespib programme, including encouraging results from Phase II studies in lung and breast cancer. In May 2014, Synta reported final results from the global, randomized, multi-center Phase IIb GALAXY-1 study comparing the combination of ganetespib and docetaxel to docetaxel alone for the second-line treatment of advanced non-small cell lung cancer (NSCLC) adenocarcinoma. The final results from this trial, in particular the encouraging overall survival results and tolerability profile in chemosensitive patients, supports the selection of the chemosensitive population for the pivotal Phase III GALAXY-2 trial.
Synta also reported that the Company's pivotal, Phase III GALAXY-2 trial of ganetespib and docetaxel vs. docetaxel alone for the 2nd line treatment of patients with NSCLC adenocarcinoma remains on track to meet previously guided data readout timelines. With a target enrolment of approximately 850 patients, and based on current projections and statistical assumptions, Synta continues to expect the two interim efficacy analyses of GALAXY-2 to be conducted by the independent Data Monitoring Committee (DMC) in the second half of 2015 and the final analysis to be conducted in the first half of 2016.
In July 2014, Synta announced the advancement of ganetespib into a Phase III extension of the AML LI-1 (less intensive) trial in newly diagnosed elderly patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) who are not eligible for intensive chemotherapy. In addition, Synta has recently announced that enrolment has begun in the Phase 1 safety portion of the GANNET53 trial in ovarian cancer.
Aeterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ): Ergomed is working with Aeterna Zentaris on the Phase III pivotal trial comparing zoptaerlin doxorubicin with doxorubicin ("ZoptEC" study) as second line therapy for locally-advanced, recurrent or metastatic endometrial cancer. The ZoptEC study is being conducted in North America, Europe, Israel and other countries under a Special Protocol Assessment and will involve approximately 500 patients. The primary efficacy endpoint is improvement in median overall survival.
Aeterna Zentaris recently announced that over 115 sites are now in operation and more than half of the patients have been enrolled. The ZoptEC study is on track to reach the number of patients required to secure the first interim analysis in the first half of 2015.
Ferrer: Ergomed is on track to start the Phase II study in insomnia in Q4 2014 with first patient dosed early in 2015. Site selection and initiation has commenced and the study is on plan
Miroslav Reljanovic, CEO of Ergomed plc, commented: "We are very pleased with the progress in our current co-development partnerships. We also note that two of our partnered assets are being developed in additional indications that have the potential to deliver clinical data which can increase their commercial value. We are in detailed discussions with regards to potential new co-development partnerships and expect to announce further deals in the next six months. We believe the co-development model has the potential to generate significant value for Ergomed shareholders through the effective execution of clinical studies through flexible partnerships."