On February 14, 2022 Datar Cancer Genetics Inc reported that the US Food and Drug Administration (FDA) has granted ‘Breakthrough Device Designation’ for its ‘TriNetra-Prostate’ blood test to detect early-stage prostate cancer (Press release, Datar Cancer Genetics, FEB 14, 2022, View Source [SID1234608106]). This is the second test from the Company that has received the Breakthrough Device Designation from the US FDA. Last year, the Company’s early-stage breast cancer detection test became the first such test to receive the Breakthrough Device Designation.

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In the United States, prostate cancer is the third most common type of cancer; each year, more than 200,000 men are detected with prostate cancer and is associated with more than 32,000 deaths. The test can identify individuals who are more likely to harbour cancer in the prostate and aids clinical decision making such as the need to undergo a biopsy for confirmatory diagnosis.

Studies have shown that TriNetra-Prostate can detect early-stage cancer with high accuracy (>99%) without any false positives. TriNetra-Prostate requires 5 ml blood and is indicated for males of age 55-69 years with serum PSA of 3 ng/mL or higher. TriNetra-Prostate is based upon the detection of prostate adenocarcinoma specific Circulating Tumor Cells (CTCs) in the blood.

"The breakthrough device designation is a recognition of the potential benefits of TriNetra-Prostate in the clinical setting. The test can help reduce the number of biopsies among individuals with benign conditions of the prostate and it can also improve detection rates among those who do have prostate cancer. With our proprietary CTC-enrichment and detection technology, there is virtually no risk of false positives among individuals who do not have prostate cancer," said Dr Vineet Datta, Executive Director of the Company. The test has previously received CE certification and is already available in Europe as ‘Trublood-Prostate’.

The Breakthrough Device Designation is granted by the FDA for devices that demonstrate a potential for more effective diagnosis of life-threatening diseases such as cancer. The Breakthrough Devices Program intends to provide patients and healthcare providers with timely access to medical devices granted such designation by prioritized review to expedite development and assessment.

On February 14, 2022 Children’s Hospital Los Angeles reported A new study independently verified the value of a system that assesses hepatoblastoma risk in children (Press release, Children’s Hospital Los Angeles, FEB 14, 2022, View Source [SID1234608105]). Hepatoblastoma is a rare childhood liver cancer, usually seen within the first three years of a child’s life with 50 to 70 cases occurring in the U.S. each year. The researchers also discovered the potential for tumor histology—the examination of a tumor’s tissue and its structure—to predict a patient’s hepatoblastoma prognosis.

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Leo Mascarenhas, MD, MS, Deputy Director of the Cancer and Blood Disease Institute, co-led the study with Shengmei Zhou, MD, a pediatric pathologist and diagnostician at CHLA. The findings are published in JAMA Network Open.

Risk stratification for hepatoblastoma

The risk assessment process, called risk stratification, has the potential to improve success rates for children undergoing hepatoblastoma treatment. Risk stratification can also reduce unnecessary exposure to chemotherapy. Often, treatment for low-risk cases is too aggressive, or liver transplants are not prioritized for high-risk cases.

In 2016, leading hepatoblastoma researchers from around the world created the Children’s Hepatic tumors International Collaboration Hepatoblastoma Stratification (CHIC-HS). Information such as age at diagnosis, whether the tumor has spread within the body and alpha fetoprotein level (which is usually increased in liver cancer) contributes to the CHIC-HS risk categorization. This database of clinical trial data aims to establish a common approach to staging and risk stratification. The CHIC-HS system has yet to be globally adopted, however, due to a lack of validation.

"Independent validation is valuable for others to use this risk stratification," emphasizes first author Dr. Zhou. "It gives them confidence."

Validating the CHIC-HS system

The study retrospectively tested the CHIC-HS system on an independent cohort of patients diagnosed and treated at Children’s Hospital Los Angeles from 2000 to 2016. The team examined the electronic medical records, imaging and pathology of 96 patients.

The investigators confirmed that the CHIC-HS system successfully predicts how much risk a tumor poses. Children in the lower-risk categories improved with minimal treatment. Those in higher-risk groups required a more intense treatment approach.

The CHIC-HS system also corresponded with long-term patient outcomes after treatment. These outcomes include overall survival, and how long a patient lives without relapse or cancer progression.

For 84 of the patients included in the study, tumor histology collected before treatment was available for analysis. Pretreatment biopsies, which provide tissue samples of the tumor, are not always possible or commonly collected. Having a cohort of this size offered a unique opportunity to assess the relationship between histological characteristics in the tumor, risk category and patient survival.

The investigators discovered that certain histological features predicted patient risk and long-term outcomes, including relapse and survival rates. "Histology may help further enhance the risk stratification scale," concludes Dr. Mascarenhas. "Our hope is that our work will be proven in the ongoing Pediatric Hepatic International Tumor Trial." (NCT03533582, North America; NCT03017326, Europe).

Ongoing research at CHLA focuses on the identification of genetic markers that may further contribute to risk stratification and inform hepatoblastoma treatment.

"This cancer, from being a pretty deadly cancer, is now highly curable in a lot of patients," says Dr. Mascarenhas. "A lot of our goals should really be aimed at limiting the toxicity of treatment in these patients and, for those with high-risk disease, figuring out how to improve their outcomes."

Additional authors of the paper include: Jemily Malvar, MS, of Children’s Hospital Los Angeles and Yueh-Yun Chi, PhD, James Stein, MD, Larry Wang, MD, PhD, Yuri Genyk, MD, and Richard Sposto, PhD, of Children’s Hospital Los Angeles and the Keck School of Medicine at USC.

This research was funded in part by grants UL1TR001855 from the National Center for Advancing Translational Science and 5P30CA014089-44 from the National Cancer Institute of the U.S. National Institutes of Health. The research also received support from the Society for Pediatric Pathology Young Investigator Research Grant and the Names Family Foundation.

On February 14, 2022 Aethlon Medical, Inc. (Nasdaq: AEMD), a company developing medical technology to treat cancer and life-threatening infectious diseases, reported financial results for its third quarter ended December 31, 2021 and provided an update on recent developments (Press release, Aethlon Medical, FEB 14, 2022, View Source [SID1234608097]).

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Company Updates

Aethlon Medical is continuing the research and clinical development of the Hemopurifier, our therapeutic blood filtration system that can bind and remove life-threatening viruses and harmful exosomes from blood. This action has potential applications in cancer, where cancer associated exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases, including removal of COVID-19 virus, associated variants, and related exosomes.

As disclosed previously, the Aethlon Hemopurifier has demonstrated binding of SARS-CoV-2 spike protein and, as reported in a peer reviewed publication, the binding and removal from circulation of SARS-CoV-2 virus from a human patient. That publication also noted that the Hemopurifier has demonstrated the removal of exosomes and exosomal microRNAs associated with coagulopathy and acute lung injury.

We continued to make progress in our Severe COVID trial during the quarter under our open Investigational Device Exemption (IDE) for the Hemopurifier for life threatening viral infections. We now have three hospitals, Hoag Newport Beach, Hoag Irvine, and Loma Linda Medical Center, fully open for patient enrollment and they are actively screening patients for the trial. An additional five centers, including UC Davis, LSU Shreveport, Thomas Jefferson Medical Center, University of Miami and Valley Baptist Medical Center, are expected to be open for enrollment in the near future.

We have also completed all site initiation activities at Medanta Medicity Hospital in India for our planned Severe COVID-19 clinical trial in that country. This site is now open for enrollment and is actively screening patients for the trial.

In addition to our work with COVID-19, we continue to screen patients for our IDE clinical trial in Head and Neck Cancer. We are looking to expand this trial to one or more additional sites to accelerate patient recruitment and we are also considering initiating additional trials, both domestically and abroad, to investigate the Hemopurifier as a treatment for other forms of cancer.

Financial Results for the Third Quarter Ended December 31, 2021

At December 31, 2021, Aethlon Medical had a cash balance of approximately $20.4 million.

Aethlon recorded approximately $17,000 of revenue related to the cost reimbursable subaward arrangement with the University of Pittsburgh in connection with an NIH contract entitled "Depleting Exosomes to Improve Responses to Immune Therapy in HNNCC." Aethlon recorded the $115,000 invoice submitted under its Phase 2 Melanoma Cancer Contract as deferred revenue, since certain of the milestones for the period were not achieved. As a result, Aethlon recorded total government contract revenue of approximately $17,000 in the three months ended December 31, 2021. Aethlon recorded approximately $625,000 of government contract revenue in the three months ended December 31, 2020.

Consolidated operating expenses for the three months ended December 31, 2021 were approximately $2.55 million, compared to approximately $3.07 million for the three months ended December 31, 2020. This decrease of approximately $520,000, or 17%, in the 2021 period was due to decreases in payroll and related expenses of approximately $520,000 and in professional fees of approximately $190,000, which were partially offset by an increase in general and administrative expenses of approximately $190,000.

The $520,000 decrease in payroll and related expenses was primarily due to the combination of a $440,000 accrual in the December 2020 period related to the separation agreement with our former CEO and $250,000 in bonuses paid in the December 2020 period, with no comparable expenses in the December 2021 period. Additionally, stock-based compensation expense decreased by $180,000 in the December 2021 period, largely due to the separation agreement with our former CEO. Partially offsetting those decreases were $180,000 in relocation-related compensation to two senior executives that relocated to San Diego, California as a condition of their employment, and increases in cash-based compensation of approximately $90,000 and $89,000 in our general and administrative payroll and in our research and development payroll, respectively, due to headcount increases.

The $190,000 decrease in our professional fees was primarily due to a $80,000 decrease in our scientific consulting expenses, a $51,000 decrease in our legal fees, a $37,000 decrease in recruiting fees, a $19,000 decrease in website services, and a $17,000 decrease in our directors’ compensation, which were partially offset by a $17,000 increase in our accounting fees.

The $190,000 increase in general and administrative expenses during the quarter ended December 31, 2021 was primarily due to a $183,000 increase in our clinical trial expenses.

As a result of the changes in revenues and expenses noted above, Aethlon’s net loss before noncontrolling interests increased to approximately $2.5 million for the three months ended December 31, 2021, from approximately $2.4 million for the three months ended December 31, 2020.

The unaudited condensed consolidated balance sheet for December 31, 2021 and the unaudited condensed consolidated statements of operations for the three and nine month periods ended December 31, 2021 and 2020 follow at the end of this release.

Conference Call

The Company will hold a conference call today, Monday, February 14, 2022 at 4:30 p.m. Eastern Time to review financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.

Interested parties can register for the conference by navigating to View Source
Please note that registered participants will receive their dial in number upon registration.

Interested parties without internet access or unable to pre-register may dial in by calling:
PARTICIPANT DIAL IN (TOLL FREE): 1-844-836-8741
PARTICIPANT INTERNATIONAL DIAL IN: 1-412-317-5442

All callers should ask for the Aethlon Medical, Inc. conference call.

A replay of the call will be available approximately one hour after the end of the call through March 14, 2022. The replay can be accessed via Aethlon Medical’s website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada Toll Free at 1-855-669-9658. The replay conference ID number is 2728183.

On February 14, 2022 Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX: TBP) (OTCQB: TBPMF) (FRA:JAM1) a leader in cannabinoid-derived drug discovery and development reported that it has executed a non-binding term sheet with Avicanna Inc. ("Avicanna") (TSX: AVCN) (OTCQX: AVCNF) (FSE: 0NN) to assess entering into a strategic partnership comprising of three strategic pillars, including (Press release, Tetra Bio Pharma, FEB 14, 2022, View Source [SID1234608096]):

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The registration and commercialization of Tetra’s various prescription products (REDUVO AdVersa, QIXLEEF and CAUMZ) across Avicanna’s channels in Latin/South America. This opens the door for Tetra to initiate sales earlier than planned.
Supply of Avicanna’s Active Pharmaceutical Ingredients (APIs) for Tetra’s pharmaceutical pipeline. The phyto-cannabinoid APIs would be sourced from Avicanna’s low cost and sustainable operations in Colombia.
Co-development and support for Avicanna’s pharmaceutical pipeline for Health Canada and FDA level clinical development and registration.
Steeve Neron, Chief Commercial Officer at Tetra stated, "Tetra will need multiple reliable suppliers of API, like Avicanna, to support QIXLEEF operations leading to its successful marketing authorization and global sales and distribution. QIXLEEF is Tetra’s proprietary investigational new drug and is currently being evaluation in two U.S. FDA-authorized clinical trials. Additionally, Avicanna’s established distribution channels in Latin/South America may help advance Tetra’s product commercialization in select jurisdictions".

Aras Azadian, Chief Executive Officer of Avicanna also commented on the opportunity. "We look forward to collaborating with the Tetra team who has in many ways been pioneering cannabinoid- prescription products. As the global industry continues to mature and shift its focus towards evidence-based medicines, the two companies are well positioned to work in synergy across several projects and leverage their leadership positions into fruitful commercial results."

On February 14, 2022 The Janssen Pharmaceutical Companies of Johnson & Johnson reported initial results from the Phase 3 MAGNITUDE study evaluating the investigational use of niraparib, a selective poly-ADP ribose polymerase (PARP) inhibitor, in combination with abiraterone acetate plus prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC) with or without specific homologous recombination repair (HRR) gene alterations (Press release, Johnson & Johnson, FEB 14, 2022, View Source [SID1234608095]). At the final analysis for radiographic progression-free survival (rPFS), the treatment combination of niraparib and abiraterone acetate plus prednisone demonstrated a statistically significant improvement in patients with HRR gene alterations. Results will be featured in a late-breaking oral presentation (Abstract #12; Oral Abstract Session A) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s Genitourinary (ASCO GU) Cancers Symposium, taking place in San Francisco and virtually from February 17-19, 2022.

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MAGNITUDE (NCT03748641) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study evaluating the safety and efficacy of the combination of niraparib and abiraterone acetate plus prednisone as a first-line therapy in patients with mCRPC. The MAGNITUDE study was intentionally designed with two independent cohorts to assess treatment effect in patients with and without HRR gene alterations (including ATM, BRCA1, BRCA2, BRIP1, CDK12, CHEK2, FANCA, HDAC2, PALB2 alterations) versus standard of care. The cohort of patients with prospectively-identified HRR gene alterations enrolled 423 patients, with patients randomized to receive the combination of niraparib and abiraterone acetate plus prednisone (combination arm [n=212]) or placebo and abiraterone acetate plus prednisone (control arm [n=211]). At 18.6-month median follow-up, patients in the combination arm of the cohort with HRR gene alterations showed a significant improvement in rPFS, with a reduction in the risk of progression or death of 27 percent (hazard ratio [HR] 0.73; p=0.022). This improvement was most pronounced in patients with BRCA1/2 gene alterations, where a 47 percent risk reduction was observed for rPFS (HR 0.53; p=0.001), as analyzed by blinded independent central review (BICR). A consistent but greater improvement was observed in investigator-assessed rPFS, which showed an overall 36 percent risk reduction in patients with HRR gene alterations (HR: 0.64; p=0.002), and a 50 percent risk reduction in patients with BRCA1/2 gene alterations (HR: 0.50; p=0.0006).1

The cohort without HRR gene alterations (n=233) met the predefined futility criteria in August 2020, showing no benefit from the treatment combination (HR>1) in the HRR biomarker negative population.1 Enrollment into this cohort was stopped at the time of futility at the recommendation of the Independent Data Monitoring Committee. Investigators and patients were unblinded and given the opportunity to continue treatment with niraparib and abiraterone acetate plus prednisone or receive only abiraterone acetate plus prednisone at the discretion of the study investigator.

"When choosing a treatment plan for patients with prostate cancer, physicians must consider individual needs, particularly for patients with mCRPC with HRR gene alterations who face a poor prognosis," said Dr. Kim Chi, Medical Oncologist at BC Cancer – Vancouver and principal investigator of the MAGNITUDE study.* "The MAGNITUDE data provide important context about the subgroup of patients with prostate cancer who may benefit from treatment with niraparib in combination with abiraterone acetate plus prednisone in the first-line setting, as well as those who may be better served by other treatment options."

In patients with HRR gene alterations, clinically relevant improvements in outcomes were also seen at this first interim analysis for secondary endpoints including time to initiation of cytotoxic chemotherapy, time to symptomatic progression and time to PSA progression. Additionally, objective response rate was improved by the combination of niraparib and abiraterone acetate plus prednisone. Overall survival data were immature at this interim analysis and follow-up will continue for all secondary endpoints.1

"These data suggest clinically meaningful improvements in outcomes in patients with prostate with HRR gene alterations who may derive benefit from this combination regimen, highlighting the importance of biomarkers to guide the patient selection process," said Mary Guckert, RN, MSN, Vice President, Development Leader, Prostate Cancer, Janssen Research & Development, LLC. "The design of this trial aligns with the real-world setting as it includes patients with prostate cancer who were able to start first-line standard of care treatment, while awaiting HRR biomarker results, and shows the need to prospectively test for and identify patients most likey to benefit from the combination of niraparib and abiraterone acetate with prednisone."

The observed safety profile of the combination of niraparib and abiraterone acetate plus prednisone was consistent with the known safety profile of each agent. Of the patients with HRR gene alterations, 67 percent experienced Grade 3 adverse events (AEs) and 46.4 percent experienced Grade 4 AEs, largely driven by anemia and fatigue. Discontinuation rates for the combination arm and control arm were 10.8 percent and 4.7 percent respectively. The combination of niraparib and abiraterone acetate plus prednisone also maintained overall quality of life in comparison with placebo and abiraterone acetate plus prednisone as measured on the Functional Assessment of Cancer Therapy–Prostate (FACT-P) scale.1

Patients with HRR gene alterations, such as BRCA1/2, are at an increased risk of developing prostate cancer, and BRCA-related prostate cancer is usually aggressive.2 Long-term survival is low for patients with mCRPC and those who have HRR gene alterations face a worse prognosis, driving a significant unmet medical need for novel therapies in this disease.3,4

About MAGNITUDE
MAGNITUDE is a Phase 3 randomized, double-blind, placebo-controlled, multicenter clinical study evaluating the safety and efficacy of the combination of niraparib and abiraterone acetate plus prednisone as a first-line therapy for patients with mCRPC, with or without certain HRR gene alterations. The study includes two cohorts in which patients were randomized to receive either niraparib and abiraterone acetate plus prednisone or abiraterone acetate (placebo) plus prednisone cohorts: one cohort of patients with predefined HRR gene alterations (including ATM, BRCA1, BRCA2, BRIP1, CDK12, CHEK2, FANCA, HDAC2, PALB2 alterations) and one cohort of patients without HRR gene alterations. In a third, open-label cohort, all patients received a combination tablet of niraparib and abiraterone and a separate tablet of prednisone. The primary endpoint of the MAGNITUDE trial is rPFS. Secondary endpoints include time-to-initiation of cytotoxic chemotherapy, time to symptomatic progression, and overall survival.

About Niraparib
Niraparib is an orally administered, selective poly-ADP ribose polymerase (PARP) inhibitor, that is currently being studied by Janssen for the treatment of patients with prostate cancer. Additional ongoing studies include the Phase 3 AMPLITUDE study evaluating the combination of niraparib and abiraterone acetate plus prednisone in a biomarker-selected patient population with metastatic castration-sensitive prostate cancer and QUEST, a Phase 1b/2 study of niraparib combination therapies for the treatment of mCRPC.

In April 2016, Janssen Biotech, Inc. entered a worldwide (except Japan) collaboration and license agreement with TESARO, Inc. (acquired by GSK in 2018), for exclusive rights to niraparib in prostate cancer. In the U.S., niraparib is indicated for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy; for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy; for the treatment of adult patients with advanced ovarian, fallopian tube or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either: a deleterious or suspected deleterious BRCA mutation, or genomic instability and who have progressed more than six months after response to the last platinum-based chemotherapy. Niraparib is currently marketed by GSK as ZEJULA.5

About Metastatic Castration-Resistant Prostate Cancer
Metastatic castration-resistant prostate cancer characterizes cancer that no longer responds to androgen deprivation therapy and has spread to other parts of the body. The most common metastatic sites are bones, followed by lymph nodes, lungs and liver.6 Prostate cancer is the second most common cancer in men worldwide, behind lung cancer.2 More than one million men around the world are diagnosed with prostate cancer each year.7 Patients with mCRPC and HRR gene alterations have a worse prognosis than those without HRR alterations.8