NOVATEK PHARMACEUTICALS
Pipeline
1. CLINICAL TRIAL:
"To Evaluate the Safety and Efficacy of NP-101 in Cancer Covid-19 Participants
(BOSS-Covid-19)"
Study Design
| Study Type : | Interventional (Clinical Trial) ClinicalTrials.gov Identifier: NCT04914377 |
| Estimated Enrollment: | Up to 60 participants Recruitment status: Completed |
| Allocation: | Randomized (1:1) |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | This was a randomized, double-blind, placebo-controlled phase II study to assess the safety and efficacy of NP-101 versus placebo in the treatment of patients who have tested positive for novel Coronavirus 2019 (Covid-19) in the outpatient setting.. Participants were randomized 1:1 to receive either 3 g per day of NP-101 or placebo (identical in appearance). The participants received up to 14 days of dosing. |
| Masking: | Participant, Investigator, and Sponsor |
| Masking Description: | Double-blind study |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of NP-101 in Treating Participants Who Have Tested Positive for Novel Coronavirus 2019 (BOSS-Covid-19) |
| Actual Study Start Date: | June 8, 2021 |
| Actual Primary Completion Date: | December 16, 2021 |
| Study Completion Date: | January 1, 2022 |
2. MULTICENTER CLINICAL TRIAL:
"Study of the Safety, Tolerability and Efficacy of NP-101 in Treating High Risk Participants Who Are Covid-19 Positive. (BOSS-002)"
Study Design
| Study Type : | Interventional (Treatment) |
| Estimated Enrollment: | 308 participants |
| Allocation: | Randomized |
| Intervention Model: | Adaptive |
| Intervention Model Description: | This is a Phase IIa/IIb multicenter, interventional, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and efficacy of NP-101 in outpatient high-risk COVID-19 positive participants. The study is comprised of two parts (Phase IIa and Phase IIb) and four cohorts. The first part of the trial (IIa) involves three cohorts and is a dose escalation study designed to select the maximum tolerated dose for use in the second part (IIb) of the study. In the dose escalation (Phase IIa) portion of the trial (n= 60), qualified participants will be enrolled in a parallel dose escalation design and randomized in a 3:1 [active+best supportive care (BSC):placebo+BSC]ratio to one of three cohorts of 20 participants each (15 active +BSC, 5 placebo + BSC). Cohort 1 (15 participants taking 600 mg capsules for a total daily dose of 3 grams of NP-101 plus BSC and 5 participants taking placebo plus BSC), and Cohort 2 (15 participants taking 600 mg capsules for a total daily dose of 4.8 g of NP-101+ BSC and 5 participants taking placebo plus BSC will run concurrently since acceptable safety data for the 3 g dose was obtained in an earlier phase II study. Cohort 1 will receive either 3 g Total Daily Dose (TDD) of NP-101 + BSC or Placebo+ BSC, Cohort 2 will receive either 4.8 g TDD of NP-101 +BSC or placebo + BSC) and Cohort 3 (15 participants taking 600 mg capsules for a total daily dose of 6 g of NP-101 + BSC and 5 participants taking placebo plus BSC.) Safety will be evaluated according to the terms of the Statistical Analysis Plan (SAP). In the second portion of the trial (Phase IIb), Participants enrolled in Cohort 4 (n= 248) will be randomized in a ratio of 1:1 (active+BSC : placebo+BSC) and will receive the Maximum Tolerated Daily Dose (MTDD) as determined by the parameters set by the SAP and approved by the DMC. |
| Masking: | Participant, Investigator, and Sponsor |
| Masking Description: | Double-blind study |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double Blind, Placebo-Controlled, Multicenter, Phase IIa/IIb Study to Evaluate the Safety, Tolerability, and Efficacy of NP-101 in Treating High-Risk Participants Who Have Tested Positive for Novel Coronavirus 2019 (BOSS-COVID-19-002). |
| Actual Study Start Date: | March 2023 |
| Estimated Primary Completion Date: | October 22, 2023 |
| Estimated Study Completion Date: | December 22, 2023 |
3. MULTICENTER CLINICAL TRIAL
"NP-101 With Nivolumab and Ipilimumab in Advanced or Metastatic Extra-pulmonary Neuroendocrine Carcinomas, in Collaboration with Case Western Reserve University, UH Seidman Cancer Center"
Study Design
| Study Type : | Interventional (Treatment) |
| Estimated Enrollment: | 10 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | A pilot study to evaluate the anti-tumor efficacy of this novel combined regimen (NP-101 plus nivolumab and ipilimumab) in the second-line setting for EP-NECA. NP-101 (TQ, C10H12O2) is the main bioactive component of the black seed (Nigella sativa, Ranunculaceae family) and has anti-oxidant, anti-angiogenic effects. The purpose of this study is to find out if NP-101 given with the immunotherapy drugs called nivolumab and ipilimumab helps with neuroendocrine carcinoma who have progressed on at least one first line standard therapy. NP-101 black seed oil tablet is an investigational (experimental) drug that may enhance the effect that immunotherapy drugs such as nivolumab and ipilimumab have on neuroendocrine carcinoma. |
| Masking: | None (Open Label) |
| Masking Description: | N/A |
| Primary Purpose: | Treatment |
| Official Title: | Pilot Study of NP-101 in Combination With Nivolumab and Ipilimumab in Advanced and Metastatic Extra-pulmonary Neuroendocrine Carcinomas (EP-NECAs). |
| Actual Study Start Date: | December 15, 2022 |
| Estimated Primary Completion Date: | April 2023 |
| Estimated Study Completion Date: | December 2024 |