NOVATEK PHARMACEUTICALS

Pipeline

1. CLINICAL TRIAL:

"To Evaluate the Safety and Efficacy of TQ Formula in Cancer Participants"

Study Design:

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment: 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a randomized, double-blind, placebo-controlled phase II study to assess the safety and efficacy of TQ Formula versus placebo in the treatment of cancers/diseases in an outpatient setting. Participants will be randomized 1:1 to receive either 3 g per day of TQ Formula or placebo (identical in appearance). The participants will receive up to 14 days of dosing.
Masking: Double (Participant, Investigator)
Masking Description: Double-blind study
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of TQ Formula in Treating Participants Who Have Colorectal Cancer, Gastroesophageal Cancer, Poorly Diff Neuroendocrine Carcinoma or Cholangiocarcinoma.
Actual Study Start Date: June 8, 2021
Estimated Primary Completion Date: July 2023
Estimated Study Completion Date: October 2023
 

Study Design:

Study Type :Interventional  (Clinical Trial)
Estimated Enrollment:60 participants
Allocation:Randomized
Intervention Model:Parallel Assignment
Intervention Model Description:Click to view
Masking:Double (Participant, Investigator)
Masking Description:Double-blind study
Primary Purpose:Treatment
Official Title:Click to view
Actual Study Start Date:June 8, 2021
Estimated Primary Completion Date:July 2021
Estimated Study Completion Date:October 2021
 

2. MULTICENTER CLINICAL TRIAL:

"To Combine TQ Formula to Immunotherapy in Neuroendocrine Carcinoma, in Collaboration with Case Western Reserve University, UH Seidman Cancer Center"

Study Design:

Study Type : Interventional  (Treatment)
Estimated Enrollment: 308 participants
Allocation: Randomized
Intervention Model: Adaptive
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, IIb) and four cohorts. The first part of the trial (IIa) utilizes three cohorts and is a dose escalation study designed to select the maximum tolerated dose for the IIb part of the study.
Masking: Double (Participant, Investigator)
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: December 2022
Estimated Primary Completion Date: July 2023
Estimated Study Completion Date: October 2023
 

3. NOVATEK PRESS RELEASE

Novatek Pharmaceuticals Initiates A Randomized, Double-Blinded, Placebo-Controlled Phase 2 Study Of Its Oral Drug, TQ Formula, Against Novel Coronavirus 2019 (COVID-19) In The Outpatient Setting

Novatek Pharmaceuticals, INC announced today that the company received FDA approval for its investigational new drug (IND) study; Phase 2 clinical trial for its oral drug, TQ Formula, against Novel Coronavirus 2019 (COVID-19) in the outpatient setting. The study is currently enrolling patients, with 16 out of 60 patients already randomized with no reported serious adverse events (SAEs) reported, to-date.

This is a randomized, double-blind, placebo-controlled phase II study where participants will be randomized 1:1 and will receive up to 14 days of oral dosing.

This therapy may provide the first potential oral treatment for COVID-19 different variants, recognizing the global emergency of new SARS-CoV-2 variants, Novatek Pharmaceuticals, Inc. has commenced development of additional pre-clinical experiments against new COVID-19 variants as it is very critical to have access to therapeutic options now and beyond the pandemic.

About TQ Formula

  • TQ Formula is an oral GMP-manufactured drug, which represents a concentrated enteric-coated formulation of Nigella Sativa oil, with higher than average thymoquinone concentration.
  • In Vitro Viral Studies indicate that TQ Formula blocks the viral entry of SARS-CoV-2 (Covid-19) variants through inhibiting angiotensin converting enzyme 2 (ACE-2).

About the phase 2 study
This is a randomized (1:1), double-blind, placebo-controlled phase 2 study to assess safety and efficacy of the oral drug, TQ Formula (3 g daily dose of enteric-coated Nigella Sativa Oil) capsules versus placebo in treating patients who have tested positive for novel Coronavirus 2019 (Covid-19) in the outpatient setting.

Patients will be treated at a dose of 500 mg, 3 capsules, two times a day for 14 days from date of randomization. Quantitative viral load as measured by RT-PCR will be evaluated at baseline and on days 7 and 14. Covid-19 symptoms will be measured throughout the study using Modified FLU-PRO Plus. Primary endpoint s of the study are:

Study Population: Up to 60 participants will be randomized 1:1 to receive either TQ Formula Capsules + Standard of Care (SOC) or placebo +SOC

Approximately 2-4 centers in the United States

TQ Formula (Nigella Sativa) 500 mg, 3 capsules, BID, taken orally

About Novatek Pharmaceuticals
Novatek Pharmaceuticals, Inc., was recently formed based on years of pre-clinical and preliminary clinical experience with nigella sativa and thymoquinone in different diseases, most recently including pre-clinical anti cancer & disease effects, suggesting that TQ Formula may also have activity against other diseases. NP-101 is the primary drug developed naturally through extraction from Black Seed oil and enhancing the TQ formula. The company will closely manage work sub-contracted to CROs and CDMOs. We have a team of clinically trained professionals with extensive experience in basic and clinical research.

We are a company that focuses on the potentially beneficial roles of TQ against cancer in the context of antioxidant, anti-inflammatory, immunomodulatory, epigenetic modulation, antiviral activity, docking studies on cancerous activity, antiviral effects for the treatment of various diseases.

MEDIA CONTACT:
877-666-8283,
mkaseb@novatekpharmaceuticals.com,
okasseb@novatekpharmaceuticals.com,
aludtke@novatekpharmaceuticals.com

NOVATEK PHARMACEUTICALS

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