Candidate: Zofin™ (Organcell™ Flow)

Type: Nanoparticle therapeutic derived from amniotic fluid and containing approximately 400 billion Extracellular Vesicles per milliliter. Extracellular Vesicles are nanovesicles that contain protein and microRNA that can be transferred to other cells to support tissue repair and homeostasis.

2021 Status: Positive Initial Results in India—Organicell said the first 10 COVID-19 patients treated with Zofin in India all recovered from their symptoms and have since been discharged from the hospital, in a trial conducted by the company and CWI India. The 10 were treated at Narayana Hrudayalaya Hospital in Bangalore, Lisa Hospital in Kozhikode, Kerala and Prime Indian Hospital in Chennai.

Based on the initial results of this trial, the trial will be expanded to an additional 65 patients with moderate to severe COVID-19, who will be treated at those hospitals over the next several weeks, with treatments expected to be completed by the end of June 2021. Should the expanded trial also yield positive results, Organicell and CWI India said, they intend to file with the ICMR (Indian Council for Medical Research) for Emergency Use Approval to use Zofin in India as a therapeutic for treating COVID-19.

2020 Status: Organicell said November 18 that it began enrolling patients at an additional site, Larkin Hospital North in Hialeah, FL, for its Phase I/II clinical trial assessing Zofin in treatment of COVID-19. The multi-center, randomized, double-blinded, placebo-controlled study will evaluate the safety and potential efficacy of intravenous infusion of Zofin for the treatment of moderate to severe acute respiratory syndrome (SARS) related to COVID-19. Organicel said the study will be enrolling 20 participants.

As of November 17, several patients had already begun treatment at Larkin Hospital South in South Miami, FL.

In September, the FDA granted intermediate-size patient population expanded access to Zofin for patients in outpatient and inpatient facilities infected with SARS-CoV-2 who have mild to moderate COVID-19, or who are judged by a healthcare provider to be at high risk of progression to moderate disease. The FDA approval followed six patients who reported significant improvement after being treated with Zofin after being treated under emergency INDs.

According to Organicell, Zofin, is the first acellular therapy which, aside from convalescent plasma, can be accessed under FDA’s approved expanded access program.

Organicell is enrolling moderate to severe COVID-19 patients for a Phase I/II randomized, double blinded, placebo placebo-controlled trial (NCT04384445) designed to evaluate the safety and potential efficacy of Zofin. Organicell began patient enrollment earlier in September at Larkin Community Hospital in Miami. At the time, the company trumpeted positive results of treatment with Zofin on two mild to moderate COVID-19 patients and one “Long Hauler” post COVID-19 patient after the FDA granted emergency, expanded access approval. The mild to moderate patients were treated three days after testing positive for COVID-19.

The first patient experienced common COVID-19 symptoms including weakness, shortness of breath, headache and a deep, dry frequent cough. The patient’s physician reported that after receiving two doses of Zofin, the patient’s symptoms improved dramatically; allowing him to return to daily activities, Organicell said.

The second patient had similar symptoms and suffered from multiple co-morbidity conditions including asthma which required her to take inhalers, nebulizers and intermittent steroids. She was treated with steroids and hydroxychloroquine prior to receiving the second dose. After six days, the company said, the patient’s physician reported that her symptoms had improved significantly.

The “long-hauler” patient experienced multiple ongoing symptoms classic to post COVID-19 syndrome including headaches, muscle aches, tightness in chest, brain fog, fatigue, fever and shortness of breath. After 10 days of treatment, her physician reported that she has experienced improvement in energy levels and her brain fog has disappeared, Organicell added.

On August 18, Organicell said it partnered with Alternative Research Associates and Larkin Hospital in Miami to launch the Phase I/II trial of its lead therapeutic candidate, which has been rebranded as Zofin, in patients with moderate to severe COVID-19. The randomized, double-blinded, placebo-controlled trial aims to investigate the safety and potential efficacy of perinatal sourced components for COVID-19.

As of August 18, five COVID-19 patients had been treated with Zofin under the FDA’s emergency Investigational New Drug (eIND) Program. Organicell said three of the patients were hospitalized in critical condition and regained complete recovery of lung and renal function following treatment, while the other two patients were treated as outpatients, with both showing unspecified “significant” improvements in all symptoms and will continue to be monitored.

Also to be rebranded soon is Organicell itself, with a new logo, tagline, and website to be revealed, the company said.

On August 6, Organicell said the FDA approved two outpatient Emergency Investigational New Drug Applications (eINDs) for treating mild to moderate respiratory distress due to COVID-19 with Organicell Flow. The first patient approved for the eIND showed a reduction in coughing and ability to breathe without pain after receiving three doses of Organicell Flow, according to the company. The patient had experienced moderate chest discomfort accentuated when taking deep breaths, persistent non-productive cough and fatigue upon exertion.

The second outpatient was administered the first dose of Organicell Flow on August 4, 2020, and to date, has reported improvements in all his symptoms, Organicell said. That patient previously spent seven weeks in the hospital, was admitted to the ICU twice, received Bi-Level Positive Airway Pressure (BiPAP) treatment and continued to experienced shortness of breath after hospital discharge.

In May, Organicell said two critically ill COVID-19 patients treated at Landmark Hospital in Athens, GA, with the company’s Organicell Flow product showed a “remarkable” improvement in their clinical status, lung and renal function confirmed by follow up chest X-rays and lab data. The patients—who were in their mid- to late 70s and had unspecified underlying health conditions and severe multi-organ failure—are no longer intubated, are alert, and are oriented with stable vital signs and oxygenation, the company said. Other organs such as the brain, heart, and liver showed progressive improvement in their function.

Since then, Organicell said, it has treated a third approved eIND inpatient with COVID-19 related respiratory impairment and acute kidney injury. That patient had a complete recovery of lung and renal function, and was discharged 26 days after initiation of treatment.

Earlier in May, the FDA approved two Emergency Compassionate Use IND applications for its lead product, then called Organicell Flow, for patients diagnosed with moderate to severe acute respiratory syndrome (SARS) due to COVID-19 infection. The company said the Phase I/II trial will be the first randomized, double-blinded, placebo-controlled, multi-center study designed to investigate the safety and potential efficacy of amniotic fluid sourced components for COVID-19.

COVID-19: 300 Candidates and Counting

To navigate through the >300 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:

FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.

DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.

KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.

TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.

GEN has also tagged the most common treatment types:


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