Palm Beach, FL – October 29, 2019 – There is much activity in the nanotechnology & nanomedicine markets as new treatments and human clinical trials are growing at a record pace. And these new treatment are hope they could be key to combating viral infections such as, bacteria, viruses, fungi, HBV, hepatitis C, Influenza, HSV, Human papillomavirus and parasites account for approximately 15 million deaths worldwide, with acute respiratory infections and human immunodeficiency virus (HIV) being the leading causes. The National Institutes for Health NCBI Center for Biotechnology Information (NCBI) reports: “Infectious diseases are the leading cause of mortality worldwide, with viruses in particular making global impact on healthcare and socioeconomic development. In addition, the rapid development of drug resistance to currently available therapies and adverse side effects due to prolonged use is a serious public health concern. The development of novel treatment strategies is therefore required. The interaction of nanostructures with microorganisms is fast-revolutionizing the biomedical field by offering advantages in both diagnostic and therapeutic applications. Nanoparticles offer unique physical properties that have associated benefits for drug delivery.” Mentioned in today’s commentary includes: TG Therapeutics, Inc. (NASDAQ: TGTX), NanoViricides, Inc. (NYSE: NNVC), Matinas BioPharma Holdings, Inc. (NYSE: MTNB), Clovis Oncology, Inc. (NASDAQ: CLVS), Pfizer Inc. (NYSE: PFE).
Nanoparticle-based delivery systems present new opportunities to overcome challenges associated with conventional drug therapies and have therefore attracted enormous interest in the treatment of viral infections. Nanomaterials can be engineered to incorporate conventional antiviral properties with those modifications that are unique to nanosystems (ultra small and controllable size, large surface area to volume ratio, and the ability to tailor the surface with the possibility of multi-functionalization). This is undoubtedly a promising tool for biomedical research and clinical use.
One of the more active companies in the industry includes NanoViricides, Inc. (NYSE American: NNVC). NanoViricides, a leader in nanomedicines with novel platform technology to treat difficult and life-threatening viral diseases, on October 9, 2019 announced that it has initiated bio-analytical studies as part of the required IND-enabling preclinical safety and toxicology studies of NV-HHV-101, moving towards human clinical trials.
The Company has contracted NorthEast BioLab, Hamden CT, to conduct the bio-analytical studies and facilitate the toxicokinetic analyses. These studies and analyses are part of the required general safety and toxicology studies that will go into an Investigational New Drug (IND) Application to the US FDA.
NorthEast BioLab has already performed the bio-analytical assay development and validation and is in the process of determining the concentrations of NV-HHV-101 in blood samples from the general safety and toxicology studies that are required for IND.
The company feels that the market size for its immediate target drugs in the HerpeCide™ program is variously estimated into Billions to tens of Billions of Dollars. The Company believes that its dermal topical cream for the treatment of shingles rash will be its first drug heading into clinical trials. The Company believes that additional topical treatment candidates in the HerpeCide™ program, namely, HSV-1 “cold sores” treatment, and HSV-2 “genital ulcers” treatment are expected to follow the shingles candidate into IND-enabling development and then into human clinical trials.
NanoViricides also released a report this past August that its first drug candidate, NV-HHV-101, is on track with required preclinical GLP Safety and Toxicology studies moving towards human clinical trials. The Company reports that NV-HHV-101 has been found to be safe and well tolerated in the clinical observation portion of the GLP Safety/Toxicology study of NV-HHV-101 as a dermal treatment.
The Company has previously found that NV-HHV-101 was safe and well tolerated in non-GLP safety/toxicology studies. The GLP studies are an expanded version of the non-GLP studies, with extended treatment, larger number of subjects, and stringent operational requirements as specified by the current Good Laboratory Practices guidelines for such studies.
Additional studies required for the Safety and Toxicology datasets for filing an IND are in progress.
The Company anticipates advancing NV-HHV-101 into human clinical trials for topical dermal treatment of the shingles rash as the initial indication, assuming that these studies are successful. The Company also continues to evaluate this broad-spectrum drug candidate as well as certain variations based on the same candidate, for the treatment of other herpesviruses, namely HSV-1 cold sores and HSV-2 genital herpes. The market size for its immediate target drugs in the HerpeCide™ program is variously estimated into billions to tens of billions of dollars. The Company believes that its dermal topical cream for the treatment of shingles rash will be its first drug heading into clinical trials. The Company believes that additional topical treatment candidates in the HerpeCide™ program, namely, HSV-1 “cold sores” treatment, and HSV-2 “genital ulcers” treatment are expected to follow the shingles candidate into IND-enabling development and then into human clinical trials.
In addition, the Company also recently announced that its first clinical drug candidate, NV-HHV-101, for the treatment of the Shingles virus (aka VZV), is on track with required preclinical GLP Safety and Toxicology studies moving towards human clinical trials. The Company has reported that NV-HHV-101 has been found to be safe and well tolerated in the clinical observation portion of the GLP Safety/Toxicology study of NV-HHV-101 as a dermal treatment.
NanoViricides’ current programs target a potential market opportunity of over $20 Billion. Investors are urged to view an informative video interview with Anil R. Diwan, PhD, President and Executive Chairman, who was interviewed by broadcast journalist Christine Corrado of Proactive Investors, a leading multi-media news organization, investor portal and events management business with offices in New York, Sydney, Toronto, Frankfurt, and London. Click here to access the video interview.
In other biotech news in the markets this week:
TG Therapeutics, Inc. (NASDAQ: TGTX), a biopharmaceutical company developing medicines for patients with B-cell mediated diseases, announced that the follicular lymphoma (FL) cohort of the UNITY-NHL Phase 2b pivotal trial evaluating single agent umbralisib, the Company’s novel, once daily, PI3K delta inhibitor, met the primary endpoint of overall response rate (ORR) as determined by Independent Review Committee (IRC) for all treated patients (n=118) who have received at least two prior lines of therapy including an anti-CD20 monoclonal antibody and an alkylating agent. The results met the Company’s prespecified ORR target of 40-50%. Importantly, umbralisib monotherapy appeared to be well tolerated with a safety profile consistent with previous reports.
The Company plans to present the data at a future medical conference as well as discuss the data with the U.S. Food and Drug Administration (FDA).
Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical stage biopharmaceutical company, this month announced that it has initiated its Phase 2 EnACT clinical study, which will explore the use of MAT2203 for both induction and maintenance therapy in HIV-patients with cryptococcal meningitis, a life-threatening fungal infection most commonly observed in immunocompromised individuals.
“We are extremely pleased to advance clinical development of MAT2203 for the treatment of cryptococcal meningitis,” commented Theresa Matkovits, Ph.D., Chief Development Officer of Matinas.
Clovis Oncology, Inc. (NASDAQ: CLVS) this month announced that the National Institute for Health and Care Excellence (NICE) has recommended that women with relapsed ovarian cancer in England have access to rucaparib through the Cancer Drugs Fund (CDF).1 Rucaparib is available for use within the CDF as an option for the maintenance treatment of relapsed, platinum-sensitive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to platinum-based chemotherapy in adults, based on the conditions outlined in the managed access agreement.
“Ovacome welcomes the availability of rucaparib via the CDF as an option for maintenance treatment of platinum-sensitive relapsed high grade serous epithelial ovarian cancer regardless of BRCA status or line of treatment in the relapsed maintenance setting,” said Victoria Clare, CEO of Ovacome, a United Kingdom ovarian cancer charity focused on providing support to anyone affected by ovarian cancer.
Pfizer Inc. (NYSE: PFE) reported financial results for third-quarter 2019 and updated certain components of its 2019 financial guidance. Third-Quarter 2019 Revenues of $12.7 Billion, Reflecting 3% Operational Decline; Excluding the Impact from Consumer Healthcare, Third-Quarter 2019 Revenues were Flat Operationally – See the full financial reporting at: https://finance.yahoo.com/news/pfizer-reports-third-quarter-2019-104500229.html
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