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First Wave BioPharma Announces Independent Data Monitoring Committee Provides Positive Interim Safety Assessment for Part 2 COVID-19 RESERVOIR Clinical Trial of Niclosamide for the Treatment of Gastrointestinal Infections
BY GlobeNewswire
— 7:00 AM ET 11/30/2021
BOCA RATON, Fla., Nov. 30, 2021 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc. ( FWBI), , (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that an independent data monitoring committee (DMC) has recommended that enrollment continue in Part 2 of the ongoing RESERVOIR Phase 2 trial evaluating FW-COV as a treatment for COVID-19-related gastrointestinal (GI) infections. FW-COV is a proprietary, oral, tablet formulation of micronized niclosamide developed to remove SARS-CoV-2 (SARS2), the virus that causes COVID-19, from the GI tract.
The DMC recommendation was based on its review of the safety data collected from the first 25 patients enrolled in Part 2 of the RESERVOIR trial. The review of the data uncovered no safety issues. Part 2 of the study will enroll up to 150 patients.
James Sapirstein, President and CEO of First Wave BioPharma ( FWBI), stated, “The DMC’s review of interim safety data was very positive with no substantive safety issues documented in the initial 25 patients dosed in Part 2 of the RESERVOIR trial. This news comes at a critical time in the COVID-19 pandemic with the rise of the fast-spreading Omicron variant, declared last week by the World Health Organization as a variant of concern. Because niclosamide targets the entire virus, and not just the spike protein, we believe that FW-COV may prove effective against multiple strains of COVID-19 and may provide an effective therapeutic to help millions of COVID-19 patients overcome the debilitating and often overlooked effect the virus can have on the GI system. Based on current timelines and pacing of enrollment, which is strong, we expect to report topline results from the RESERVOIR trial next year, including an assessment of FW-COV’s ability to clear the COVID-19 virus from the GI tract.”
RESERVOIR is designed as a two-part, two-arm, randomized, placebo-controlled Phase 2 study with a primary purpose to confirm the safety of FW-COV and assess the drug’s ability to remove the SARS-CoV-2 (SARS2) virus from the digestive tract. Patients enrolled in Part 2 of the study are randomized to receive either niclosamide or a placebo treatment for 14 days. After 14 days, patients will cease treatment but remain under observation for up to six weeks, with additional follow-up observations at 4 month and 6-months to assess persistence or recurrence of symptoms. The efficacy of FW-COV is measured by the rate of SARS2 clearance from stool samples assessed by PCR test, comparing the niclosamide arm and the placebo arm. Long-term observation could indicate whether niclosamide treatment has the potential to prevent “long haul” COVID-19 symptoms.
James Pennington, M.D., Chief Medical Officer of First Wave BioPharma ( FWBI), commented, “Despite vaccination campaigns and booster shots, COVID-19 and its growing family of dangerous variants continue to spread, and the virus’ lingering effects have developed into a major medical issue for millions of people. Research suggests SARS2 may form reservoirs in the GI tract and cause illness long after the abatement of the initial infection. Early data demonstrated that our micronized oral niclosamide therapy is well tolerated, and we believe that FW-COV may have the ability to remove these viral reservoirs from the GI tract, adding a much needed drug to the COVID treatment regimen.”
Additional information about the RESERVOIR trial can be found at www.covidgi.com and on ClinicalTrials.gov.
RespireRx Pharmaceuticals Inc. Announces Publication of Preclinical Results Supporting the Use of AMPAkines in the Treatment of Human Spinal Cord Injury
BY GlobeNewswire
— 8:45 AM ET 11/29/2021
Glen Rock, N.J.,, Nov. 29, 2021 (GLOBE NEWSWIRE) -- RespireRx Pharmaceuticals Inc. ( RSPI ) (“RespireRx” or the “Company”), a leader in the discovery and development of innovative and revolutionary treatments to combat diseases caused by disruption of neuronal signaling, is pleased to announce the publication by Dr. David Fuller (University of Florida) and his colleagues of two new, scientific articles in major, peer-reviewed journals. In these new studies funded by grants from the National Institutes of Health, Dr. Fuller, a long-time RespireRx collaborator, describes the ability of CX1739 and CX717, the Company’s lead AMPAkines, to improve motor nerve activity and muscle function in animal models of spinal cord injury (SCI).
The first paper entitled “Spinally delivered ampakine CX717 increases phrenic motor output in adult rats” was published online ahead of print in the journal Respiratory Physiology and Neurobiology (https://doi.org/10.1016/j.resp.2021.103814) and describes the ability of direct spinal administration of CX717 to increase the amplitude of motor nerve activity on the side ipsilateral (same side) to that in which a unilateral cervical transection had been made to anesthetized and ventilated rats.
Commenting on these results, Arnold Lippa, Ph.D., Chief Scientific Officer and Executive Chairman of the Board of Directors said, “In combination with prior studies, these new results demonstrate that AMPAkines may potentially have broad effects on both the brain and spinal cord to enhance spinal plasticity and improve motor function in patients with different forms of SCI.”
Unlike the above and all prior published articles, the second paper entitled “Ampakines stimulate diaphragm activity after spinal cord injury” was published online ahead of print in the Journal of Neurotrauma (http://doi.org/10.1089/neu.2021.0301) and describes research conducted for the first time in awake freely moving rats as late as two weeks after having previously undergone unilateral spinal hemi-transection at the C2 spinal level. For the first time, low dose administration of either CX1739 or CX717 was shown to improve not only motor nerve and muscle activity recorded electrophysiologically from the lesioned side, but to significantly improve actual motor functioning and breathing, even under challenging conditions. The importance of these findings is described in the article by pointing out that the majority of the approximately 500,000 annual SCI cases reported globally involve injuries to the cervical spinal cord and, in severe cases, require the use of mechanical ventilation or direct diaphragm pacing to sustain ventilation. Also, in confirmation of previously reported results in anesthetized animals, the AMPAkines improved, in awake freely moving animals, the motor facilitation produced by an episode of acute intermittent hypoxia (AIH), a treatment currently used in the rehabilitation of SCI patients.
As Dr. Fuller concluded in this paper, “Our study provides evidence that even lower ampakine doses can effectively stimulate breathing and diaphragm muscle activity in a pre-clinical model of cervical-SCI, with no evidence of adverse effects. Furthermore, ampakine treated animals are capable of increasing respiratory motor drive to a larger degree when challenged, a response often dampened in SCI patients. Lastly, the current data suggest that pairing low-dose and low impact ampakines with even a single brief hypoxia exposure may have value in the context of neurorehabilitation paradigms.”
Dr. Lippa said, “As part of our ongoing AMPAkine collaboration with Dr. Fuller, these exciting new research results add considerable support to the concept that AMPAkines might be a new therapeutic alternative for significantly improving clinical recovery from SCI, when given alone or in combination with other types of rehabilitation. As such, they strengthen our intention to translationally extend this work to human clinical trials.”
Website for what?
I realize that what we say here, our predictions, are based on nothing but hope. But, eventually, out of the blue, there should be a PR about a reverse merger. The CEO is not staying current with filings for fun, it's for money.
I agree. I have never seen such a beating.
Really good interview. Margolis represented RSPI quite well.
RespireRx Pharmaceuticals Inc. Announces Video Interview of CFO
BY GlobeNewswire
— 8:45 AM ET 11/04/2021
Glen Rock, N.J., Nov. 04, 2021 (GLOBE NEWSWIRE) -- RespireRx Pharmaceuticals Inc. ( RSPI) , (“RespireRx” or the “Company”) a leader in the discovery and development of innovative and revolutionary treatments to combat diseases caused by disruption of neuronal signaling, is pleased to announce the public availability of a video interview of its Senior Vice President, Chief Financial Officer, Treasurer and Secretary, Jeff Margolis, by ProActive Investors.
On Thursday, November 4, 2021, a recorded video interview of Jeff Margolis will be available for viewing by the general public by following this link:
Google him. He is there.
That looks very good.
Geesh, this CEO is a busy guy.
Pretty typical Friday. Relatively low volume, nothing dramatic happening. Surprised there was news today.
Good response N.A.T. Thanks.
Can someone tell me how many of the 28B O/S are restricted or tied up in some way? That is, what is the float?
Like I said earlier, I don't even see the 8K in my usual place in my online brokerage account. I wonder how many have not seen the news yet.
It just isn't showing in Fidelity in the usual places, but I suppose it will.
Link to Haj Finance Group looks good to me.
https://hajfinancegroup.com/
How come the 8K is not showing under SEC filings?
I have to admit that I am becoming a believer.
Wow! Great volume and up 30%.
I've been hearing this every day here for two years. But sooner or later, you could be right.
Where does one even see the dial-in info for this CC? I see no announcement about it at all.
I'm feeling better and better about my investment here. Seems that we are on solid ground, with blue skies ahead for growth and expansion.
There will always be someone to dump when news hits. You just have to hope there are more buyers than sellers.
Finally breaking out.
Excellent 7-minute video.
So far, nice volume and pps increase. Not sure why, but I like it.
I get it. So we wait and see.
I agree. OTC companies NEVER buy back stock, and they almost never make it to the NASDAQ. These are fantasies that some CEOs tell their potential shareholders. On the other hand, this stock is really interesting because of the diversity of holdings, so I'm in for the ride.
Hmm. Can you post what you find under Exhibit 3?
I see all of that, but I want to open the Exhibit links.
I cannot get the exhibit links to open in the 8K. Anyone else?
652 million
We'll trade more than 1 billion shares today.
Wow. Strong buying pressure today. Some group has decided to come in, IMO.
I really wish we would get some merger news now.
IMO, you are exactly correct.
Excellent analysis, and I agree totally. I've been here for 7-8 years, and I'm not budging.
OTC companies typically domicile in NV because the regulations are looser than in other states.
I was impressed with Henry. This is an amazingly ambitious project for an OTC company. And no buyback would be large enough to affect the pps, with 26b shares O/S. That would not be a good use of company funds, given all that is needed now to develop Five Grains, etc. Anyone who counted on that move to change this up was smoking something strong.
Thank you jackrabbits.
Do we have any details on when and where the CC can be heard?
Wow! Where in the world did Henry get $100 million???