Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Dead money.
Innovation Pharmaceuticalsā Investment in BT BeaMedical Helping Advance New Surgical Laser Platform
WAKEFIELD, MA / September 13, 2022 Innovation Pharmaceuticals (OTCQB:IPIX) (āthe Companyā), a clinical stage biopharmaceutical company, today updated shareholders on recent progress by BT BeaMedical Technologies Ltd. (āBeaMedā) (formerly known as Squalus Medical Ltd.) to advance its new image guided surgical laser platform for treating previously inoperable cases of epilepsy and for enabling new treatment options for cancer cases in multiple specialties. In June 2022, the Company announced acquiring an interest in BeaMed.
BeaMed has informed the Company that it has initiated important software integration work; engaged regulatory agencies on appropriate development steps via the 510(k) pathway; formalized a distribution relationship with Fortec Medical (www.fortecmedical.com), which has access to over 2700 hospitals in the U.S.; and identified key opinion leaders to serve in scientific advisory capacities. BeaMed anticipates additional value-added events to occur as it aims to reshape laser guided surgery with its unique directed laser technology system.
More information on BeaMed can be found on its company website and via a presentation by BeaMed management introducing the company, at the links below.
BeaMed company website:
www.beam-med.com
BeaMed management introduction to company:
www.youtube.com/channel/UCyoklsj7NfFMpPzC81sXzHg
Almost hit 2 pennies todayā¦..
Spectrum Pharmaceuticals Announces Poster Presentation for Poziotinib in NSCLC Patients with G778_P780dup HER2 Exon 20 Mutations at the Upcoming ESMO Congress 2022
Source: Business Wire
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced a poster presentation titled: High Activity of Poziotinib in G778_P780dup HER2 Exon 20 Insertion Mutations in Non-Small Lung Cancer (NSCLC). The poster will be presented at the upcoming European Society for Medical Oncology Congress (ESMO) 2022 that will take place in Paris from September 9-13, 2022.
Details of the ESMO poster presentation are as follows:
Title: High Activity of Poziotinib in G778_P780dup HER2 Exon 20 Insertion Mutations in Non-Small Lung Cancer (NSCLC)
First Author: Xiuning Le, M.D., Ph.D., Assistant Professor, Department of Thoracic/Head and Neck Medical Oncology, Division of Internal Medicine, The University of Texas MD Anderson Cancer Center, Houston
Location: Hall 4
Date: Monday, September 12, 2022
Presentation Number: 1172P
The poster will be available for viewing by registered participants during the conference via the ESMO website on September 10, 2022. It will also be available on the Investor Relations section of the companyās website at https://investor.sppirx.com/index.php/events-and-presentations.
About Poziotinib
Poziotinib is a novel, oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4. Importantly this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. HER2 exon 20 insertion mutations are a rare subset accounting for approximately 2-4% in NSCLC. There is no approved therapy specifically for either treatment-naïve or previously treated NSCLC with HER2 exon 20 insertion mutations. The company holds an exclusive license from Hanmi Pharmaceutical to develop, manufacture, and commercialize poziotinib worldwide, excluding Korea and China.
Good summary.
Press Release:
Provider and Payer Analysis Supports Potential Commercialization of Innovation Pharmaceuticalās Brilacidin as a Novel Oral Mucositis Drug Candidate
WAKEFIELD, MA / July 22, 2022 / ACCESSWIRE Innovation Pharmaceuticals (OTCQB:IPIX) (āthe Companyā), a clinical stage biopharmaceutical company, today provided an update on the Companyās Brilacidin program in Oral Mucositis (OM). Brilacidin, delivered as an oral rinse, was shown in Phase 2 clinical testing (NCT02324335) to reduce incidence, delay onset and decrease duration of severe OM (WHO Grade ≥ 3) in Head and Neck Cancer (HNC) patients receiving chemoradiation. The Company and FDA have completed an End-of-Phase 2 meeting and agreed to an acceptable Phase 3 program.
To assess current insurance programs and Brilacidinās overall commercialization potential in OM, the Company engaged separate consulting firms to analyze the provider and payer landscape -- specifically, the likelihood of clinicians to prescribe and insurers to reimburse a novel OM treatment, such as Brilacidin, should it eventually gain marketing approval. Results of this analysis are summarized below.
Large Unmet Need: Oral Mucositis (OM) presents a significant socioeconomic cost to the healthcare system and to patients, as it can substantially impact quality of life, result in hospitalization, and lead to disruptions in anti-cancer therapy and poorer outcomes. Current standard of care (SOC) treatment options (primarily devices) are lacking because they only act as symptom management and do not decrease incidence of severe OM (SOM).
Competitive Positioning: Brilacidinās oral sachet formulation was perceived as convenient and highly preferred by key opinion leaders (KOLs) in comparison to intravenous (IV) options, and KOLs are willing to prescribe Brilacidin for all HNC patients because the compoundās preventative properties and ease of use as an oral rinse. Brilacidin has the potential to be a first-line product for prevention and treatment of SOM due to efficacy perceived as being highly clinically meaningful.
Development Considerations: KOLs viewed the primary endpoint of reducing SOM incidence as favorable, though recommend additional secondary endpoints to promote greater uptake (i.e., reduction of opioid usage, overall pain level, and time to onset of SOM). Maximizing overall efficacy (reduction of SOM) was identified as a higher KOL priority than the specific mechanism of action (anti-inflammatory activity) by which efficacy is achieved.
Coverage Perspectives: Developing Brilacidin as a New Drug Application (NDA), via the 505(b)(1) pathway, significantly improves Brilacidinās commercialization prospects in the OM therapeutic area. OM products, such as MuGard, GelClair, Episil, and Caphosol, which were developed as devices and not drugs, have struggled to show clinical benefit, as they are primarily palliative in nature, and from a government payer perspective are not covered under Medicare Part D.
Reimbursement Landscape: At least 2 approved drugs in all therapeutic drug classes must be made available under Medicare Part D, per USP Medicare Model Guidelines. The guidelines establish the framework (the rules) that drive payer formularies. Given there are no approved drugs for OM in HNC, should Brilacidin be approved, it is highly likely it would be included in payer formularies as a pharmacy benefit.
Commercial Opportunity: Annually, in the U.S., Brilacidin has the potential to address 52,000 OM patients in HNC, with potential future extension to 20,000 OM patients in Hematopoietic Stem Cell Transplantation (HSCT), and 160,000 OM patients in all chemotherapy categories. Based on physician estimates of Brilacidin adoption and other pricing-based assumptions, forecasts of U.S. annual sales are $188 million for OM in HNC patients in 2030, with a potential additional upside of $106 million for OM in HSCT and $598 million for OM in all chemotherapy categories.
āThis analysis reinforces Brilacidinās potential to become a breakthrough OM treatment and commercialization success,ā said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. āWhile our focus on Brilacidin over the last few years has been in the antiviral space, given COVID-19, we have made meaningful strides to advance Brilacidin in OM, including refinement of the oral rinse formulation in sachet form. We continue to pursue partnering opportunities so Brilacidin can be further advanced in oral mucositis in the clinic.ā
Additional information on the Brilacidin-OM revenue opportunity based on this analysis is available on the Companyās website at the link below:
https://www.ipharminc.com/new-blog/2022/7/22/brilacidin-revenue-opportunity-in-oral-mucositis
About Oral Mucositis
Oral Mucositis (OM) is a painful and debilitating complication of chemoradiation.1 Head and Neck Cancer (HNC) patients, comprising an estimated 66,000 newly diagnosed cases in the U.S. in 20212, and an estimated 900,000 worldwide3, are at high risk of developing OM. By 2030, the global incidence of HNC cases is expected to exceed 1 million per year. Moreover, between 25 and 60 percent of cancer patients, regardless of cancer type, also will experience OM. Characterized by inflammation and ulceration, patients suffering from OM are often unable to speak and eat (requiring the insertion of a feeding tube) and are more susceptible to infections, with severe cases leading to hospitalization at increased treatment costs of up to $25,000. There currently are no approved medications for the prevention of OM in the HNC population, with only limited palliative care options available. Worldwide, the OM market was estimated to be $1.5bn in 2021.4
1 The broadening scope of oral mucositis and oral ulcerative mucosal toxicities of anticancer therapies - Elad - 2022 - CA: A Cancer Journal for Clinicians - Wiley Online Library
2 Cancer Statistics, 2021 - PubMed (nih.gov)
3 Global Cancer Observatory (iarc.fr)
4 Oral Mucositis Market Size, Epidemiology, Market Research 2032 (delveinsight.com)
How does this story finally end one day? Captain still at the wheel of the ship?
Floating higher?
Whatās going on ?
IPIX Reports Brilacidin Inhibits Omicron, Delta, Gamma and Alpha SARS-CoV-2 Variants Based on In Vitro Testing by NIH/NIAID-Sponsored and Rutgers University Researchers
WAKEFIELD, MA / June 23, 2022 / ACCESSWIRE Innovation Pharmaceuticals (OTCQB:IPIX) (āthe Companyā), a clinical stage biopharmaceutical company, today reported that Brilacidin, the Companyās defensin-mimetic drug candidate exhibiting broad-spectrum antiviral activity, inhibited the Omicron (B.1.1.529) and Delta (B.1.617.2) variants of SARS-CoV-2 based on in vitro testing conducted in collaboration with National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID) scientists. Researchers at Rutgers University have also shown Brilacidin inhibited in vitro the Gamma (P.1) and Alpha (B.1.1.7) variants of SARS-CoV-2.
Brilacidin has now been tested in vitro in seven SARS-CoV-2 strains (Omicron, Delta, Gamma, Alpha, Italian, Washington, Wuhan) and three human coronavirus (H-CoV) strains (OC43, 229E, and NL63), in addition to MERS-CoV and SARS-CoV-1. Brilacidin has consistently inhibited all coronaviruses tested, independent of cell type, at generally attainable systemic concentrations (based on established human pharmacokinetics of IV-administered Brilacidin).
Identifying COVID-19 countermeasures with novel mechanisms of action is vital. SARS-CoV-2 continues to evolve at an accelerated pace, raising questions as to what the dominant variant (or sub-variant) may be this fall and winter, when infections often spike -- and if todayās COVID-19 vaccines and therapeutics can maintain their effectiveness.
Emerging SARS-CoV-2 variants, and increasingly their sub-variants, contain immunity-evading mutations. These mutations alter key parts of the SARS-CoV-2 spike protein that attach to human cells, making the virus more transmissible and potentially more virulent. Unlike other antivirals, such as monoclonal antibodies, and most vaccines, Brilacidin has been shown not to target the Spike S1 and Spike RBD regions of SARS-CoV-2, acting instead through dual-acting neutralizing and blocking antiviral properties, able to target virus and host. These antiviral traits support Brilacidinās ability to maintain its anti-coronavirus activity and suggest Brilacidin would be less subject to resistance.
Related, results from new NIH/NIAID in vitro testing of Brilacidin in over 20 acutely infectious viruses, and from the Brilacidin Phase 2 COVID-19 clinical trial, are being prepared for publication. Findings from the Rutgersā Brilacidin research can be accessed at the link below1 and build on earlier published Brilacidin research conducted by scientists at George Mason University and at University of Arizona and University of California-San Francisco.
In 2021, the Company completed a Phase 2 clinical trial of Brilacidin (NCT04784897) for treatment of moderate-to-severe COVID-19 patients. While the trial did not meet its primary endpoint in reducing time to sustained recovery through day 29, certain patient subgroups did show treatment benefits of Brilacidin for that primary endpoint. For example, patients treated early from onset of symptoms achieved sustained recovery more quickly (Brilacidin 5-dose group vs pooled placebo, p=0.03). To date, only a modicum of success has been demonstrated by any company conducting clinical trials in moderate-to-severe hospitalized cases of COVID-19. A possible reason for this may be owing to frequent changes in the standard of care with patients receiving a cocktail of fluctuating concomitant medications, which complicates the interpretation of the clinical trial data and that of the new drug candidate being evaluated. Clinical observations of COVID-19 patients treated with Brilacidin further lead us to believe that higher and more frequent dosing of Brilacidin may be more appropriate to tackle this complex disease in the hospital setting.
Taken together, the results from NIH/NIAID testing of Brilacidin are supportive of previously completed research and give the Company confidence in the compoundās antiviral potential. The Company remains active in pursuing additional government-based funding opportunities, as well as licensing partnerships, to advance Brilacidin in the highly attractive area of developing novel broad-spectrum medicines for treating viral diseases.
1Theresa L Chang, et al. āBrilacidin, a Non-Peptide Defensin-Mimetic Molecule, Inhibits SARS-CoV-2 Infection by Blocking Viral Entry.ā EC Microbiol. 2022 Apr; 18(4):1-12.
Heās trying to sell the company for what he can get for it.
āAs of March 31, 2022, the Company has largely paused clinical development to strategically analyze all the scientific data collected to date across its portfolio of assets - see Item 2 for additional details.ā
Whatās the forecast in Boca Raton today?
Someone dumped some shares. Selling pressure might ease up now. End of day letās see.
End of day Friday it popped up.
Anyone have a clue why the stock popped up on Friday?
Whatās next for IPIX?
JMP Securities Thinks Spectrum Pharmaceuticalsā Stock is Going to Recover
Source: TipRanks
In a report released today, Reni Benjamin from JMP Securities reiterated a Buy rating on Spectrum Pharmaceuticals (SPPI ā Research Report), with a price target of $4.00. The company's shares closed last Friday at $0.90, close to its 52-week low of $0.60. According to TipRanks.com, Benjamin is ranked 0 out of 5 stars with an average return of -9.2% and a 35.4% success rate. Benjamin covers the Healthcare sector, focusing on stocks such as Deciphera Pharmaceuticals, Iovance Biotherapeutics, and Allogene Therapeutics. Currently, the analyst consensus on Spectrum Pharmaceuticals is a Strong Buy with an average price target of $6.00, representing a 609.4% upside.
https://www.tipranks.com/news/blurbs/jmp-securities-thinks-spectrum-pharmaceuticals-stock-is-going-to-recover-3?utm_source=advfn.com&utm_medium=referral
Innovation Pharmaceuticals Announces Publication of Peer-Review Article in the Journal of Medical Virology on Anti-Coronavirus Properties of Brilacidin
In other news, Scientific Advisor, William F. DeGrado, PhD, gives keynote lecture at 2021 Faraday Discussion and co-awarded John Scott Medal
WAKEFIELD, MA / March 15, 2022 / ACCESSWIRE Innovation Pharmaceuticals (OTCQB:IPIX) (āthe Companyā), a clinical stage biopharmaceutical company, today announced publication of a peer-review scientific article in the Journal of Medical Virology on the anti-coronavirus properties of Brilacidin. Brilacidin was shown to exert a dual-acting antiviral mechanism of action, able to target coronaviruses directly and bind to host cell surfaces to prevent viral entry.
As previously released, Brilacidin showed promising treatment effects in a Phase 2 clinical trial in moderate-to-severe hospitalized cases of COVID-19 (see NCT04784897). The Company plans to seek funding and additional clinical development support from government-sponsored programs to help advance the Brilacidin antiviral program.
Coronavirus Research Highlights
In the peer-review paper, which was co-authored by Dr. DeGrado and is accessible at the link below, University of Arizona and University of California-San Francisco scientists characterized the antiviral activity of Brilacidin against multiple endemic human coronaviruses (HCoVs), including HCoV-OC43, HCoV-229E, HCoV-NL63, and SARS-CoV-2, in human cell lines.
Hu, Y., Hyunil, J., DeGrado, W.F., & Wang, J. (2022). Brilacidin, a COVID-19 Drug Candidate, Demonstrates Broad-Spectrum Antiviral Activity Against Human Coronaviruses OC43, 229E and NL63 Through Targeting Both the Virus and the Host Cell. J Med Virol. doi:10.1002/jmv.27616.
Mechanistic studies revealed Brilacidin exerts antiviral activity by interfering with viral attachment to host cells by binding to heparan sulfate proteoglycans (HSPGs). HSPGs are important co-receptors through which different viruses gain entry into host cells, thus providing an attractive target for the development of broad-spectrum antivirals. Beyond exhibiting this blocking property, Brilacidin was also shown to target viral proteins directly, acting through a virucidal property. This dual antiviral mechanism of action suggests Brilacidin may be well-suited for prophylactic development and less likely to be subject to drug resistance. Combination studies further revealed Brilacidin exhibited a strong synergistic antiviral effect with remdesivir (Vekluryā¢) against HCoV-OC43 in cell culture. Collectively, these data support Brilacidinās translational potential to be developed as a broad-spectrum anti-coronavirus agent.
DeGrado Scientific Accolades
The Company also is pleased to announce co-discoverer of Brilacidin and Scientific Advisor for Drug Discovery and Clinical Development, William F. DeGrado, PhD, gave the keynote Spiers Memorial lecture at the 2021 Faraday Discussion and received the 2020 John Scott Medal.
Dr. DeGrado, Professor in the Department of Pharmaceutical Chemistry at UCSF, and Michael Klein, PhD, Dean of the College of Science and Technology at Temple University, were co-awarded the 2020 John Scott Medal based on their overall contributions to science, including their seminal scientific work to discover Brilacidin. The 2020 award ceremony was delayed one year due to the coronavirus pandemic. Both DeGrado and Klein are members of the National Academy of Sciences.
The Scott Awards, created in 1816 and named for the 19th-century chemist, John Scott, who endowed it in honor of Ben Franklin, are given annually to scientists whose inventions have improved the ācomfort, welfare and happinessā of humankind. The first Scott Awards were bestowed in 1834. Notable past Scott Award recipients include: Thomas Edison, Nikola Tesla, Marie Curie, Alexander Fleming, Jonas Salk, among many others. The 2021 Scott Award went to two scientists, Katalin Karikó and Drew Weissman, whose research contributed to the development of RNA-based COVID-19 vaccines.
āIt has been a real pleasure across my life to work with numerous academic and professional peers who are at the forefront of identifying new scientific approaches to develop promising medical treatments,ā said William F. DeGrado, PhD, Scientific Advisor for Innovation Pharmaceuticals. āBrilacidin is one such molecule that I believe possesses considerable therapeutic potential. I look forward to continuing my collaboration with the Innovation team, including evaluating opportunities to license novel compounds with applications in multiple areas.ā
Dr. DeGradoās 2021 Farraday Discussion talk, published by the Royal Society of Chemistry, focused on insights into Peptide-Membrane Interactions. Excerpts from the lectureāhighlighting DeGradoās and peersā discovery of Brilacidināare available on the Companyās website at the link below.
https://www.ipharminc.com/new-blog/2022/3/15/scientific-advisor-william-f-degrado-gives-keynote-lecture-at-2021-faraday-discussion-also-co-awarded-the-2020-john-scott-medal
Alerts
Sign-up for Innovation Pharmaceuticals email alerts is available at:
http://www.ipharminc.com/email-alerts/
About Innovation Pharmaceuticals
Innovation Pharmaceuticals Inc. (IPIX) is a clinical stage biopharmaceutical company developing a world-class portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, infectious diseases, and dermatologic diseases.
Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including, without limitation, statements concerning future drug development plans, statements regarding the antiviral capabilities and therapeutic potential of Brilacidin and its potential impact on SARS-CoV-2 (COVID-19) and other viruses. Other statements regarding future product developments, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause the Companyās actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as āanticipates,ā ābelieves,ā āhopes,ā āestimates,ā ālooks,ā āexpects,ā āplans,ā āintends,ā āgoal,ā āpotential,ā āmay,ā āsuggest,ā and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are risks related to conducting pre-clinical studies and clinical trials and seeking regulatory and licensing approvals for Brilacidin and Kevetrin in the United States and other jurisdictions, including without limitation that the Companyās compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere; prior test results may not be replicated in future studies and trials; the Companyās need for, and the availability of, substantial capital in the future to fund its operations and research and development, including the amount and timing of the sale of shares of common stock under securities purchase agreements; and the Companyās licensee(s) may not successfully complete pre-clinical or clinical testing and the Company will not receive milestone payments. A more complete description of these and other risk factors is included in the Companyās filings with the Securities and Exchange Commission. Many of these risks, uncertainties and assumptions are beyond the Companyās ability to control or predict. You should not place undue reliance on any forward-looking statements. The forward-looking statements speak only as of the information currently available to the Company on the date they are made, and the Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
Innovation Pharmaceuticals Reports Additional Findings Based on Review of Brilacidin Phase 2 COVID-19 Trial Results and Compassionate Use Cases
WAKEFIELD, MA / March 7, 2022 / ACCESSWIRE Innovation Pharmaceuticals (OTCQB:IPIX) (āthe Companyā), a clinical stage biopharmaceutical company, today reported findings from data review of the Companyās Brilacidin Phase 2 COVID-19 study and compassionate use of Brilacidin in critically-ill COVID-19 patients.
āBased on analyses of our Phase 2 trial results, Brilacidin showed promising treatment effects in NEWS2 clinical improvement scores and among patients with the most elevated biomarker levels,ā said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. āThese results, along with observations on the compassionate use of Brilacidin in COVID-19 related to dosing, as well as data being generated from ongoing scientific collaborations, are informing paths forward for our Brilacidin antiviral program. We believe Brilacidin has merit to help address COVID-19 and can play a role in preparing for future pandemics, given Brilacidinās unique immunomodulatory and antiviral properties. Progress in the Brilacidin antiviral program largely will be dependent upon obtaining government funding for additional clinical development and leveraging external research relationships. Going forward, our business focus will be to advance Brilacidin in other disease areas and to pursue new business opportunities through joint ventures and other investments.ā
Summary of Brilacidin COVID-19 Trial Design and Results
The Phase 2 trial (see NCT04784897) was a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of Brilacidin treatment in addition to current standard-of-care (SoC) compared to SoC alone, in 120 hospitalized patients with moderate-to-severe COVID-19.
Study treatment, Brilacidin IV or saline IV (placebo), was administered as 3 doses or 5 doses. For efficacy analyses, the main comparison was between the Brilacidin 5-dose group and the pooled placebo group.
Even with randomizationāstratified by age (<= 65 yrs, >65 yrs) and severity (moderate, severe)āpatients allocated to the Brilacidin treatment groups exhibited a greater degree of disease burden at baseline, as reflected by higher, on average, elevated biomarker levels (e.g., CRP, viral load), in contrast to the pooled placebo group.
As previously released, Brilacidin did not show a difference compared to placebo in reducing Time to Sustained Recovery Through Day 29, the study's primary endpoint based on clinical status. There was also no difference in mortality between active and placebo, with both groups experiencing low mortality rates (7 percent) compared to other studies that evaluated patients with moderate-to-severe COVID-19. Beneficial Brilacidin treatment effects, however, were observed in NEWS2 secondary endpoints, as well as on the primary endpoint in patient subgroups, as summarized below.
Pharmacokinetic (PK) analysis (from measured plasma sample concentrations) provided comparable estimations to those seen previously in the Brilacidin IV program, although exposure was generally greater than observed prior (when comparing patients on similar treatment regimens for the indication of acute bacterial skin and skin structure infections [ABSSSI]). These new PK data will help inform any future Brilacidin IV dosing strategies.
Brilacidin was generally well-tolerated by patients, with an overall safety profile in COVID-19 patients consistent with previous clinical studies. The incidence of patients with at least one treatment-emergent adverse event (TEAE) was higher for Brilacidin treatment compared to placebo. However, the proportion of patients with TEAEs is similar across groups (72 percent on active, 65 percent on placebo) after excluding the Brilacidin-related adverse events of tingling (paresthesia) and hypoesthesia (numbness), which are known, transient, mostly mild, non-serious adverse events related to Brilacidin IV treatment. The incidence of serious adverse events was the same (12 percent on active, 12 percent on placebo), and no serious adverse events were reported as related to study treatment.
Secondary Endpoint Analysis
NEWS2 Scores (Intent-to-Treat Population)
More patients in the Brilacidin 5-dose group achieved and maintained, for at least 24 hours, a National Early Warning Score 2 (NEWS2) of <=2. By 10 days (from randomization), 97 percent of the Brilacidin 5-dose group had achieved this NEWS2 endpoint compared to 84 percent of patients in the pooled placebo group. A NEWS2 score of 2 or less is clinically meaningful as an aggregate score of 4 or less translates to low clinical risk, per NEWS2 criteria.
The mean change from baseline in NEWS2 was greater for the Brilacidin treatment groups than for the pooled placebo group, at all assessment timepoints (Study Days 3, 5, 8, 11, 15, and 29).
NEWS2 is an ordinal scale developed by the U.K.ās Royal College of Physicians to identify patients at risk for rapid clinical deterioration requiring critical care intervention and is considered a valuable tool for management of COVID-19. NEWS2 is based on certain physiological parametersārespiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure, pulse, level of consciousness, and temperature. NEWS2 has been used as an endpoint for several COVID-19 clinical trials.
Post-Hoc Analysis
Inflammatory Biomarkers: Patient Subgroup with Highest Quartile Baseline Values (Per Protocol Population)
For those patients with baseline values for C-Reactive Protein (CRP) in the highest quartile (4th quartile), all patients in the Brilacidin 5-dose subgroup achieved sustained recovery through Day 29, compared to 77 percent of patients in the pooled placebo subgroup. Time to sustained recovery was on average shorter in the Brilacidin 5-dose subgroup compared to placebo.
Additionally, for those patients with baseline values for Interleukin-6 (IL-6) in the highest quartile, more patients in the Brilacidin 5-dose subgroup achieved sustained recovery through Day 29 (89 percent compared to 67 percent on placebo). Time to sustained recovery also was on average shorter in the Brilacidin 5-dose subgroup compared to placebo for this quartile of patients.
Both CRP and IL-6 levels, when elevated at baseline, have been shown to predict worse outcomes in COVID-19 patients and our data was consistent with this. These two biomarkers have been used by other pharmaceutical companies as enrollment criteria to target COVID-19 patient populations most likely to benefit from treatment. The NIH-sponsored clinical evaluation of Humanigenās drug, lenzilumab (ACTIV-5/BET-B), was updated to include, as the trialās primary endpoint, survival without ventilation by 28 days in patients with baseline CRP levels under 150mg/l.
Viral Load Biomarker: Patient Subgroup with Highest Quartile Baseline Values (Per Protocol Population)
For those patients with baseline values for viral load in the highest quartile, more patients in the Brilacidin 5-dose subgroup achieved sustained recovery through Day 29 (92 percent compared to 82 percent on placebo). Time to sustained recovery was also on average shorter in the Brilacidin 5-dose subgroup compared to placebo for this quartile of patients. This is notable given median time from symptom onset to treatment randomization averaged 9.53 days in the Brilacidin COVID-19 trial, and thus likely occurred after peak viral load in most patients.
Time from Onset of Symptoms to Randomization (Per Protocol Population)
If a patient started study treatment within fewer than 7 days of onset of COVID-19 symptoms, patients in the Brilacidin 5-dose group achieved sustained recovery more quickly compared to the pooled placebo group (p=0.03). For this patient population, early treatment with Brilacidin from onset of symptoms appeared to have a potential positive impact on time to sustained recovery (the studyās primary endpoint), suggesting cases that can be treated close to initial onset of disease may be an attractive population to target for Brilacidin treatment.
Multiple monoclonal antibodies targeting COVID-19, as well as the oral COVID-19 antiviral molnupiravir (Lagevrioā¢), failed in hospitalized patients but later achieved success in treating earlier-stage disease. The antiviral remdesivir (Vekluryā¢) also recently exhibited substantial benefit in non-hospitalized COVID-19 patients, including an 87 percent lower risk of hospitalization or death than placebo after a 3-day intravenous course of the drug.
Standard-of-Care (SoC)
Review of Brilacidin Phase 2 COVID-19 trial data showed most patients (>87 percent) received treatment with systemic corticosteroids (generally at high doses, and for long durations), and treatment with mucolytics (>82 percent), antivirals (>68 percent), analgesics (>56 percent), immunosuppressants (>45 percent), anti-thrombotic agents (>97 percent), and other supportive medications as SoC for COVID-19.
These seemingly aggressive SoC treatment strategies are likely attributable to the Delta variant of SARS-CoV-2, which became prevalent during trial enrollment and has been associated with significantly higher in-hospital mortality compared to earlier SARS-CoV-2 variants. Such implementation of a more aggressive COVID-19 SOC, as has been reported by other companies evaluating COVID-19 trial results, may have contributed to an overall lessening of observable Brilacidin treatment effects.
Brilacidin Compassionate Use in COVID-19āObserved Treatment Effects
Noticeable treatment effects attributed to the compassionate use of Brilacidin were reported by investigators. Patients receiving compassionate use of Brilacidin were at extremely advanced stages of disease and had exhausted other conventional treatment options. Compassionate use cases comprised Brilacidin being administered to critically-ill COVID-19 patients over a longer duration (up to 10 days of treatment) than in the Phase 2 COVID-19 clinical trial (3 and 5 day dosing), with some patients also receiving higher and more frequent (twice daily) dosing. There appeared to be a potentially favorable treatment response based on increased Brilacidin dosing. For the Brilacidin compassionate use cases, in general, investigators observed more stable disease with initial improvements evident on chest x-rays and in COVID-19 disease biomarkers (e.g., CRP and ferritin). While nearly all of these critically-ill patients ultimately succumbed to severe hypoxic respiratory failure (secondary to COVID-19 viral pneumonia) and expired, survival time for these patients who initially were not expected to live beyond a few days was appreciably extended.
Brilacidin Antiviral ProgramāPlanned Next Steps
Future progress in the broader Brilacidin antiviral program will largely be tied to obtaining government funding for additional clinical development while benefiting from ongoing collaborative research with NIH and other scientists. Brilacidinās broad-spectrum antiviral activity is generating positive data. Publications and conference abstracts related to this research are being prepared.
Given the need for development of new small molecule antivirals and immunomodulators, the Company is planning to submit Brilacidin for possible inclusion in government-sponsored COVID-19 trial platforms, e.g., the NIH ACTIV program. Platform trials, which typically enroll hundreds of patients per treatment arm, can more accurately evaluate the treatment potential of COVID-19 drug candidates. Pursing a biomarker-driven approach, increasing Brilacidin dosing and treatment duration, targeting different patient populations, testing Brilacidin in combination with drugs exhibiting different mechanisms of action (e.g., remdesivir, given strong synergistic in vitro data)āall are possible elements of any future Brilacidin COVID-19 trial design. Compassionate use of Brilacidin also is anticipated to continue, which could further inform Brilacidinās treatment effects in COVID-19. For more details on the Companyās Compassionate Use policy, please visit:
https://www.ipharminc.com/expanded-access-and-compassionate-use
The Company also plans to seek additional clinical development support from the NIH Antiviral Program for Pandemics (APP). Brilacidin for prophylactic use, including assessing Brilacidin in pre-clinical animal models, is of particular interest due to Brilacidinās blocking and neutralizing antiviral properties and industry investment in developing intranasal-targeted, direct-acting antivirals. Preliminary Brilacidin formulation work for inhaled delivery has been conducted, with the NIH APP a potential avenue to expand on this work, along with exploring the subcutaneous administration of Brilacidin, which has greater than 70 percent bioavailability via this route of administration.
Pipeline Advancement, Other Business Opportunities
Efforts to advance the Brilacidin Oral Mucositis (OM) program are a key focus. The Company is presently exploring timelines and scenario planningāincluding the option to seek a meeting with the U.S. Food and Drug Administration towards the initiation of a Phase 3 clinical trial evaluating oral rinse Brilacidin as a new treatment for the prevention of OM in head and neck cancer patients receiving chemoradiation. Brilacidin oral formulation development work for Ulcerative Colitis continues. The Company has also been notified by Alfasigma, its licensing partner, of their intent to initiate this year Phase 2 testing of Brilacidin in Ulcerative Proctitis/Proctosigmoiditis.
In other news, the Company is evaluating a number of potential pipeline additions and other unique business opportunities, including investments in medical-related technologies. In certain instances, management is in advanced discussions for products believed to be accretive to revenue by diversifying Innovationās portfolio. The Company will provide updates on all such matters as appropriate.
Spectrum Pharmaceuticals Presents Positive Data for Poziotinib in First-line NSCLC Patients with HER2 Exon 20 Insertion Mutations
Source: Business Wire
Data presented at ESMO TAT from Cohort 4 of the ZENITH20 clinical trial met the primary endpoint
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced the presentation of safety and efficacy results from Cohort 4 of the ZENITH20 clinical trial. This data is from 70 first-line patients with non-small lung cancer (NSCLC) with HER2 exon 20 insertion mutations who received 16 mg daily, given as 16 mg once daily (48 patients) or 8 mg twice daily (22 patients) of oral poziotinib. These results showed a confirmed objective response rate (ORR) of 41% (95% CI:30%-54%), as evaluated centrally by an independent image review committee using RECIST 1.1 criteria. The evaluable patient population showed an ORR of 50%. The study met its primary endpoint as the observed lower bound of 30% exceeded the pre-specified lower bound of 20%. The safety profile was consistent with the TKI class. The data is part of an oral presentation at the European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Congress 2022 being held virtually March 7-8, 2022.
āCohort 4 from our ZENITH 20 study demonstrated positive results for treatment naïve lung cancer patients harboring HER2 Exon 20 insertion mutations. There is currently no approved treatment for NSCLC patients with these mutations,ā said Francois Lebel, M.D., Chief Medical Officer of Spectrum. āWe are encouraged by these findings and look forward to further discussions with the FDA on the regulatory path forward.ā
The presentation is available on the Spectrum Pharmaceuticals website at: https://investor.sppirx.com/index.php/events-and-presentations.
Safety and Efficacy Data for Cohort 4 of the ZENITH20 Clinical Trial
Cohort 4 enrolled treatment-naïve NSCLC patients with HER2 exon 20 insertion mutations. This cohort investigated the efficacy of poziotinib and included patients dosed either with a QD or BID dosing strategy. Poziotinib 16 mg was administered orally once daily for the first 48 patients followed by an additional 22 patients dosed at 8 mg twice daily. Both dosing regimens allowed dose reductions/interruptions for toxicity. The primary endpoint was ORR evaluated centrally by an independent image review committee using RECIST 1.1 criteria. Secondary endpoints included disease control rate (DCR), duration of response (DoR), progression-free survival (PFS) and safety.
The primary endpoint of ORR was 41% (95% CI:30-54%) in the 70 treated patients including one complete response. The DCR was 73% (95% CI:61-83%). DoR was 5.7 months (range 1.2-19.1+). Median progression free survival (PFS) was 5.6 months (range 0-20.2+). 90% of patients had dose interruptions and 79% had reductions from the 16 mg QD starting dose, while 64% had reductions from the 8mg BID starting dose. The most common treatment related Grade ≥ 3 adverse events were rash (30%), stomatitis (19%), diarrhea (14%), and paronychia (7%). In addition, the incidence of Grade ≥ 3 pneumonitis was low at 3%. The safety profile was consistent with the TKI class and tolerability, dose reductions and interruptions were less frequent with BID dosing.
About the ZENITH20 Clinical Trial
The ZENITH20 study consists of seven cohorts of NSCLC patients. Cohorts 1 (EGFR) and 2 (HER2) in previously treated NSCLC patients with exon 20 mutations, Cohort 3 (EGFR) in first-line patients and Cohort 4 (HER2) in first-line NSCLC patients with exon 20 mutations have completed patient enrollment. Cohorts 1-4 are each independently powered for a pre-specified statistical hypothesis and the primary endpoint is ORR. Cohort 5 includes previously treated or treatment-naïve NSCLC patients with EGFR or HER2 exon 20 insertion mutations. Cohort 6 includes NSCLC patients with classical EGFR mutations who progressed while on treatment with first-line osimertinib and developed an additional EGFR mutation. Cohort 7 includes NSCLC patients with a variety of less common mutations in EGFR or HER2 exons 18-21 or the extracellular or transmembrane domains.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biopharmaceutical company focused on acquiring, developing, and commercializing novel and targeted oncology therapies. Spectrum has a strong track record of successfully executing across the biopharmaceutical business model, from in-licensing and acquiring differentiated drugs, clinically developing novel assets, successfully gaining regulatory approvals and commercializing in a competitive healthcare marketplace. Spectrum has a late-stage pipeline with novel assets that serve areas of unmet need. This pipeline has the potential to transform the company in the near future. For additional information on Spectrum Pharmaceuticals please visit www.sppirx.com.
Soleno Therapeutics to Participate in the BIO CEO & Investor Conference
Source: GlobeNewswire Inc.
Soleno Therapeutics, Inc. (āSolenoā) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that Anish Bhatnagar, M.D., Chief Executive Officer, will present a corporate overview at the BIO CEO & Investor Conference on Tuesday, February 15, 2022 at 2:15 PM Eastern Time.
About Soleno Therapeutics, Inc.
Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The companyās lead candidate, DCCR extended-release tablets, a once-daily oral tablet for the treatment of Prader-Willi Syndrome (PWS), is currently being evaluated in a Phase 3 clinical development program. For more information, please visit www.soleno.life.
Is the bottom in?
Yard sale of IPIX to Alfasigmaā¦?
Upcoming Update on Brilacidin in COVID-19
Dear IPIX Shareholders,
The Company will be providing shortly an update based on further data analysis of the Brilacidin Phase 2 COVID-19 study results and compassionate use of Brilacidin in critically-ill hospitalized COVID-19 cases.
While topline results showed Brilacidin did not meet the trialās primary endpoint, as previously announced, these findings are helping to inform potential paths forward for Brilacidin antiviral applications.
Collaborative work with NIH and other researchers on Brilacidinās broad-spectrum antiviral properties is ongoing and generating promising data, with future updates planned.
Finally, we plan to provide more information on the Companyās strategic direction, as we look to advance Brilacidin in multiple areas and evaluate additional opportunities.
Is it game over?
Pass it to Dr. Menon first. Lol!
Check both of those boxes.
IPIX in the .03ās a new 52 week low .0349
Longs still selling?
445,117,433 shares outstanding
https://www.otcmarkets.com/stock/IPIX/quote
Press Release Jan 11th IMO
New Yearā¦.bounce time?
Happy New Year!
545,000 shares on the bid
Perhaps the company will be presenting the next direction/focus at a Biotech conferenceā¦?
Interesting
Tom is the bottom in on IPIX ?