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Clinical Trials

Product Candidates

Clinical Program

Current Status

Anti-CA125 MAb

oregovomab

Combination with front-line chemotherapy in advanced Ovarian Cancer (Phase IIb)

Completed enrolment of 80 patients in 13 centers in Italy and US. Positive interim results presented at ASCO 2017.

 

Neoadjuvant immunotherapy in combination with Gemcitabine in partially resectable CA125 positive Pancreatic Cancer (pilot study)

Physician sponsored clinical trial in progress at University of Nebraska Medical Center

 

Combination with immunoadjuvant (TLR-3 agonist, Hiltonol) and chemotherapy in recurrent Ovarian Cancer 

Study in progress at 2 US centers.

 

Combination with checkpoint inhibitor and chemotherapy in recurrent Ovarian Cancer

Study in progress in Singapore.

Anti-MUC1 MAb with check point inhibitor and TLR3 agonist Anti-MUC1 MAb with check point inhibitor and/or Hiltonol to determine if modulation of MAb AR20.5 induced immune response may be enhanced by adding checkpoint inhibitor and/or immune adjuvant, Hiltonol, in a human MUC1 transgenic mouse model. Development of Phase II clinical protocol in progress. Additional pre-clinical studies in progress at University of Nebraska Medical Center

Product Candidates

Pre-Clinical Program

Current Status

Anti Her2/neu IgE MAb Pharmacological efficacy studies to broaden the mechanistic understanding of IgE therapy in a human FcεR1-MUC1 double transgenic mouse model.

Anti Her2/neu IgE master cell bank development in progress.

NRC-IRAP grant received

Oregovomab for Recurrent Ovarian Cancer (Phase Ib)

Name of Protocol:  The Safety and Antitumor Activity of the Combination of Oregovomab and Hiltonol in Recurrent Advanced Ovarian Cancer

Participiating Centers:

Dr. Robert Holloway
Florida Hospital Cancer Institute

Dr. William P. McGuire
VCU Massey Cancer Center, Dalton Oncology Clinic

 

Name of Protocol:  Phase Ib/IIa Trial to Evaluate Oregovomab and Nivolumab in Epithelial Cancer of Ovarian, Tubal or Peritoneal Origin (ORION-01)

Participiating Centers:

Dr. John Chia
National Cancer Centre Singapore

 

Oregovomab for Frontline Ovarian Cancer (Phase IIb)

Name of Protocol: A randomized controlled study on the Effectiveness of first-line chemotherapy (carboplatin and paclitaxel) versus chemoimmunotherapy (carboplatin-paclitaxel/oregovomab) in patients with advanced epithelial Ovarian, adnexal or peritoneal carcinoma

Centers in Italy:

Prof. Roberto Angioli
Policlinico Universitario Campus Bio-Medico Di Roma – Roma (RM), Ginecologia E Ostetricia
00128 Roma

Prof. Giovanni Scambia
Poloclinico Universitario Gemelli Di Roma – Roma (RM), Ginecologia E Ostetricia
00168 Roma

Dr. Francesco Raspagliesi
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano

Dr.ssa Germana Tognon
Azienda Ospedaliera Spedali Civili di Brescia
Brescia

Dr. Luigi Frigerio
Azienda Ospedaliera Ospedali Riuniti di Bergamo
Bergamo

Dr. Benedetti Panici
Policlinico di Roma Umberto
Roma

Dr. Pavese
Struttura Complessa di Oncologia Ospedale San Pietro Fatebenefratelli
Roma

Dr. Scollo
Azienda Ospedaliera Cannizzaro di Catania
Catania

Centers in United States:

Dr. Molly Brewer
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030

Dr. Michael Method
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46601

Dr. Patricia Braly
Women Cancer Care
Covington, LA, United States, 70433

Dr. Jonathan Berek
Stanford University Medical Center
Stanford, California, United States, 94305

Dr. Robert Holloway
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804

Oregovomab for Pancreatic Cancer (Phase II)

Name of Protocol: A Phase II Study of Neoadjuvant Chemotherapy with and without Immunotherapy to CA125 (Oregovomab) followed by Hypo fractionated Stereotatic Radiotherapy and Concurrent HIV Protease inhibitor Nelfinavir in patients with Locally Advanced Pancreatic Cancer

Participiating Centers:

Dr. Chi Lin
University of Nebraska Medical Center, Omaha