Pipeline
Complementary platforms that act alone or in combination with other treatments to address conditions of severe unmet medical need.
Nibrozetone (RRx-001) & 
AdAPT Program
Supportive Care (RRx-001)
| Study | Indication | Preclinical | Phase 1 | Phase 2 | Phase 3 |
|---|---|---|---|---|---|
| KEVLARx | Severe Oral Mucositis |
Cancer (AdAPT-001)
| Study | Indication | Preclinical | Phase 1 | Phase 2 | Phase 3 |
|---|---|---|---|---|---|
| BETA PRIME | Sarcoma (soft-tissue) |
Cancer (RRx-001)
| Study | Indication | Preclinical | Phase 1 | Phase 2 | Phase 3 |
|---|---|---|---|---|---|
| REPLATINUM (ex-US) | Small Cell Lung Cancer |
Neurodegenerative Diseases (RRx-001)
| Indication | Grants | Preclinical | Phase 1 |
|---|---|---|---|
| Parkinson’s | Michael J Fox Foundation Therapeutic Pipeline Program | ||
| ALS/MND | FightMND Drug Development Program Grant | ||
| Neuroprotection | Awarded - to be announced | ||
| Toxic Exposures | Awarded - to be announced |
Endometriosis (RRx-001)
| Study | Indication | Preclinical | Phase 1 | Phase 2 | Phase 3 |
|---|---|---|---|---|---|
| In Start-up | Endometriosis |
Active programsPartnership Opportunities: We welcome regional and global partnerships with like-minded companies, institutions, and investors that support our first-in-class therapies and treatment programs in oncology, radioprotection, and neurodegenerative and gynecological diseases.
Phase 3
Study: REPLATINUM: A Phase 3, Controlled, Open-label, Randomized Study of RRx-001 Administered Sequentially with a Platinum Doublet or a Platinum Doublet in Third-Line or Beyond Small Cell Carcinoma
Conditions: Small Cell Lung Cancer
Interventions: Drug: RRx-001; Drug: Cisplatin/carboplatin
Status: Active/Enrolling
Partnerships: SciClone Pharmaceuticals
Phase 2
Study: A Phase 2 Randomized, Open-Label Study of RRx-001 vs Regorafenib in Subjects With Metastatic Colorectal Cancer (ROCKET)
Conditions: Metastatic Colorectal Cancer (mCRC)
Interventions: Drug: RRx-001 (investigational drug); Drug: Irinotecan; Drug: Regorafenib (comparator)
ClinicalTrials.gov Identifier: NCT02096354
Status: Completed/ Not Enrolling
Publications: [click to view]
Phase 2b
Study: Efficacy Study of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers (KEVLARx)
Conditions: Severe Oral Mucositis (SOM) in Head & Neck Cancers (HNC)
Interventions: Drug: RRx-001 (investigational drug); Drug: Cisplatin; Radiation: IMRT
ClinicalTrials.gov Identifier: NCT03515538
Status: In Start-up (not enrolling)
Publications: [click to view]
Phase 1
Study: A Phase I, Open-Label, Multiple Ascending Dose Study of RRx-001 and Nivolumab (PRIMETIME), completed. Phase 2 study in recurrent Head & Neck Cancer (in planning)
Conditions: Solid Tumors
Interventions: Drug: RRx-001 (investigational drug); Drug: Nivolumab (Phase 2 CPI, TBD)
ClinicalTrials.gov Identifier: NCT02518958 (completed study)
Status: In Start-up (not enrolling); (Phase 2 in planning)
Publications: [click to view]
Preclinical
Study: RRx-001 for reduction of endometrial lesions and associated pain
Conditions: Endometriosis
Interventions: Drug: RRx-001 (investigational drug)
ClinicalTrials.gov Identifier: NCT02518958
Status: Preclinical studies ongoing
Preclinical
Study: RRx-001 for prevention and treatment of neurodegenerative diseases
Conditions: Parkinson’s, ALS/MND, Alzheimer’s, & others
Interventions: Drug: RRx-001 (investigational drug)
ClinicalTrials.gov Identifier: NCT02518958
Status: Preclinical studies ongoing
Grant Awards:
Phase 1/2
Study: (planning)
Conditions: Solid Tumors
Interventions: Drug: AdAPT-001 (investigational drug)
Phase 1/2
Study: A Phase 1/2, First in Human, Study to Evaluate the Safety and Tolerability of AdAPT-001 in Subjects With Refractory Solid Tumors
Conditions: Solid Tumors
Interventions: Drug: AdAPT-001 (investigational drug); Drug: Immune Checkpoint Inhibitor(s)
ClinicalTrials.gov Identifier: NCT04673942
Status: Enrolling