Investigational New Drug

PolarityTE Submits Investigational New Drug Application for SkinTE® in Chronic Cutaneous Ulcers

Monday, July 26, 2021 - 1:00pm

PolarityTE, Inc. (Nasdaq: PTE) today announced the submission of an investigational new drug application (IND) to the United States Food and Drug Administration (FDA) seeking authorization to commence a clinical trial to evaluate its SkinTE product for the proposed indication of treatment of chronic cutaneous ulcers.

Key Points: 
  • PolarityTE, Inc. (Nasdaq: PTE) today announced the submission of an investigational new drug application (IND) to the United States Food and Drug Administration (FDA) seeking authorization to commence a clinical trial to evaluate its SkinTE product for the proposed indication of treatment of chronic cutaneous ulcers.
  • Wounds closed with SkinTE have exhibited significant improvement after SkinTE application (e.g., avoidance of amputation after failure of treatment alternatives).
  • Thus, PolarityTE believes that preliminary clinical evidence suggests SkinTE could ameliorate a number of serious conditions caused by chronic cutaneous ulcers.
  • POLARITYTE, the POLARITYTE logo, SKINTE, WHERE SELF REGENERATES SELF and WELCOME TO THE SHIFT are registered trademarks of PolarityTE, Inc.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20210726005157/en/

Tryp Therapeutics Announces Plans for Phase 2a Clinical Trial for Fibromyalgia with the University of Michigan

Wednesday, July 21, 2021 - 12:00pm

The study is expected to be the world's first Phase 2a clinical trial evaluating the efficacy of psilocybin and psychotherapy to treat fibromyalgia

Key Points: 
  • The open-label Phase 2a clinical trial will evaluate the efficacy of TRYP-8802, an oral formulation of synthetic psilocybin, in tandem with psychotherapy for treating fibromyalgia.
  • The Principal Investigator for the trial will be Kevin Boehnke, Ph.D., Research Investigator, University of Michigan Department of Anesthesiology.
  • Tryp expects to submit the Investigational New Drug (IND) application to the FDA for the Phase 2a clinical trial in 3Q 2021.
  • The company has announced upcoming Phase 2a clinical trials with the University of Michigan and the University of Florida to evaluate its drug products for fibromyalgia and eating disorders, respectively.

The Worldwide Clinical Trial Industry is Expected to Reach a Value of $57+ Billion by 2026 - ResearchAndMarkets.com

Thursday, July 22, 2021 - 5:36pm

Research centers and numerous organizations enhance clinical trials' productivity and effectiveness by advancing and managing clinical trials globally.

Key Points: 
  • Research centers and numerous organizations enhance clinical trials' productivity and effectiveness by advancing and managing clinical trials globally.
  • After preclinical development, the investigational new drug passes through clinical phases I, II, III, and IV during the clinical trial.
  • It expected that the Global Clinical Trials Market will expand, registering a CAGR of 14.13% during the forecast period, 2020-2026.
  • North America is a conventional clinical trial region, and because of the legal, regulatory considerations, the clinical trial market shifted to developing nations.

FDA Provides Necessary Guidance For BioVaxys To Begin Preparation Of Ind For Phase I/II Clinical Trials Of CoviDTH

Thursday, July 22, 2021 - 2:22pm

VANCOUVER, British Columbia, July 22, 2021 /PRNewswire/ -- BioVaxys Technology Corp. (CSE: BIOV) (FRA:5LB) (OTCQB: BVAXF) ("BioVaxys"), is pleased to announce today that the US Food and Drug Administration ("FDA") has provided its official Written Response to the Company's request for a Pre-IND Type B review of CoviDTH as a diagnostic for evaluating T-cell immune response to SARS-CoV-2.

Key Points: 
  • The FDA found the Chemistry, Manufacturing and Controls, and other elements of the clinical development program proposed by BioVaxys to be acceptable and provided guidance and feedback supportive of BioVaxys' clinical development plans for CoviDTH.
  • In addition, the FDA indicated that animal toxicity studies for CoviDTH were not required and that the Company could start its clinical development program with a combined Phase I/II study.
  • Based on this feedback, BioVaxys will begin preparation of an IND application to support a Phase I/II safety, dosing, and efficacy study.
  • "With the guidance we received from this FDA review, BioVaxys is now able to begin preparing its IND," stated BioVaxys President and Chief Operating Officer Ken Kovan.

FDA Provides Necessary Guidance For BioVaxys To Begin Preparation Of Ind For Phase I/II Clinical Trials Of CoviDTH

Thursday, July 22, 2021 - 2:16pm

VANCOUVER, British Columbia, July 22, 2021 /PRNewswire/ -- BioVaxys Technology Corp. (CSE: BIOV) (FRA:5LB) (OTCQB: BVAXF) ("BioVaxys"), is pleased to announce today that the US Food and Drug Administration ("FDA") has provided its official Written Response to the Company's request for a Pre-IND Type B review of CoviDTH as a diagnostic for evaluating T-cell immune response to SARS-CoV-2.

Key Points: 
  • The FDA found the Chemistry, Manufacturing and Controls, and other elements of the clinical development program proposed by BioVaxys to be acceptable and provided guidance and feedback supportive of BioVaxys' clinical development plans for CoviDTH.
  • In addition, the FDA indicated that animal toxicity studies for CoviDTH were not required and that the Company could start its clinical development program with a combined Phase I/II study.
  • Based on this feedback, BioVaxys will begin preparation of an IND application to support a Phase I/II safety, dosing, and efficacy study.
  • "With the guidance we received from this FDA review, BioVaxys is now able to begin preparing its IND," stated BioVaxys President and Chief Operating Officer Ken Kovan.

Antares Pharma Announces FDA Acceptance of IND Application for ATRS-1902 for Adrenal Crisis Rescue

Thursday, July 22, 2021 - 1:30pm

EWING, N.J., July 22, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (the Company), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug Application (IND) for ATRS-1902 for adrenal crisis rescue.

Key Points: 
  • EWING, N.J., July 22, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (the Company), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug Application (IND) for ATRS-1902 for adrenal crisis rescue.
  • The FDA acceptance of this IND is an important milestone in the development of a novel formulation and delivery of hydrocortisone in a crisis situation.
  • Current standard of care for the management of acute adrenal crises includes Solu-Cortef, which is an anti-inflammatory glucocorticoid.
  • Robert F. Apple, President and Chief Executive Officer of Antares Pharma, added, We are pleased to be able to advance the development of our proprietary pipeline with the FDA acceptance of this IND.

Viracta Therapeutics Announces FDA Clearance of IND Application for Phase 1b/2 Trial in Epstein-Barr Virus-Positive (EBV+) Solid Tumors

Wednesday, July 21, 2021 - 1:00pm

Food and Drug Administration(FDA) has cleared Viracta's Investigational New Drug (IND) application to proceed into a Phase 1b/2 trial in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) and other EBV+ solid tumors.

Key Points: 
  • Food and Drug Administration(FDA) has cleared Viracta's Investigational New Drug (IND) application to proceed into a Phase 1b/2 trial in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) and other EBV+ solid tumors.
  • "Clearance of this IND application is a crucial milestone that underscores the broader applicability of our therapeutic approach to treating patients with EBV-associated malignancies," said Lisa Rojkjaer, M.D., Chief Medical Officer of Viracta.
  • "EBV is the primary etiologic agent for NPC, one of the most commonly reported head and neck cancers worldwide.
  • Viracta assumes no obligation and does not intend to update these forward-looking statements, except as required by law or applicable regulation.

Organicell Announces FDA Approval Of IND Application For The Use Of Zofin™ In COVID-19 Long Haulers

Wednesday, July 21, 2021 - 12:55pm

This approved trial design consists of a double blinded, placebo-controlled, randomized phase I/II trial designed to investigate the safety and potential efficacy of Zofin in treating COVID-19 long haulers.

Key Points: 
  • This approved trial design consists of a double blinded, placebo-controlled, randomized phase I/II trial designed to investigate the safety and potential efficacy of Zofin in treating COVID-19 long haulers.
  • These patients, called COVID-19 "long haulers," report lingering shortness of breath, cough, fatigue, and mental fog for months after recovery, impairing their return to work and everyday life.
  • Even by the lowest health care industry estimates, the magnitude of this secondary health crisis of COVID-19 long haulers will result in millions of affected individuals.
  • Organicell has no intention and specifically disclaims any duty to update the information in this press release.

Generate Life Sciences Establishes Newborn Stem Cell Manufacturing Facility to Support the Development of Personalized Therapeutics

Thursday, July 15, 2021 - 1:00pm

LOS ANGELES, July 15, 2021 /PRNewswire/ -- Generate Life Sciences (Generate) today announced the establishment of its Good Manufacturing Practice (GMP) facility in La Jolla, Calif. which will enable end-to-end manufacturing for newborn stem cell biologics.

Key Points: 
  • LOS ANGELES, July 15, 2021 /PRNewswire/ -- Generate Life Sciences (Generate) today announced the establishment of its Good Manufacturing Practice (GMP) facility in La Jolla, Calif. which will enable end-to-end manufacturing for newborn stem cell biologics.
  • This facility will represent a big step in the evolution of Generate and its broader life sciences platform adding the role of a personalized therapeutics developer with in-house manufacturing capabilities to its core international donor gamete, genetics service and newborn stem cell preservation business.
  • The new Generate facility has been designed to harness these inherent properties to maximize bioprocessing efficiency and manufacture at scale.
  • "The La Jolla GMP facility will be a crucial addition to Generate's vision for our newborn stem cell operation," said Jaime Shamonki, MD, Generate's Chief Medical Officer.

Direct Biologics Announces FDA Acceptance of IND Application for a Phase I/II Clinical Trial Studying ExoFlo for Acute Respiratory Distress Syndrome

Wednesday, July 14, 2021 - 6:45pm

Direct Biologics is the only EV company with INDs approved for the full breadth of COVID-19 indications, as well as ARDS.

Key Points: 
  • Direct Biologics is the only EV company with INDs approved for the full breadth of COVID-19 indications, as well as ARDS.
  • ExoFlo provides signaling proteins that have been shown to modulate inflammation and may stimulate bioactivity and direct cellular communication.
  • Direct Biologic's management team holds extensive collective experience in biologics research, development, and commercialization, making the Company a leader in the evolving, next-generation segment of the biotherapeutics industry.
  • Direct Biologics is dedicated to pursuing additional clinical applications of ExoFlo through the FDA's investigational new drug application process.For more information, visit www.directbiologics.com .