On January 20, 2022 Veeva Systems (NYSE: VEEV) reported that the Lymphoma Academic Research Organization (LYSARC) selected Veeva Development Cloud to improve operational efficiency across its lymphoma therapy research (Press release, LYSA Lymphoma, JAN 20, 2022, View Source [SID1234605648]). LYSARC will use applications in Vault Clinical, Vault Quality, and Vault Safety suites to build a robust, connected technology foundation that enables faster execution, higher quality data, and better trial oversight.

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"Partnering with Veeva will accelerate our digital transformation for greater scalability and speed in our pursuit to develop innovative lymphoma therapies or improve current therapies," said Franck Morschhauser, president of LYSARC. "Using Veeva Development Cloud gives us a single connected platform that can free our staff from time-consuming tasks and allow them to focus on what drives us every day: scientific excellence for the benefit of lymphoma patients."

The largest European academic organization devoted to lymphoma clinical research, LYSARC recruits more than 750 patients every year across Belgium, France, and Portugal. To expand its reach, the organization is collaborating with other academic groups in Europe or abroad, in partnership with pharma companies, and needed technology that can scale with its growth.

Veeva Development Cloud will bring together clinical, quality, and safety operations for end-to-end business processes and execution. With a digital and unified systems landscape, LYSARC can improve the patient trial experience, ensure alignment with SOPs across stakeholders, and reduce the costs and lead times of clinical trials.

"LYSARC is fully invested in empowering its teams with advanced technologies to evolve how they work together in a complex environment," said Jim Reilly, vice president of Vault R&D and Quality at Veeva Systems. "We’re proud to work with an organization dedicated to innovation, and we look forward to supporting their development of new lymphoma research and therapies."

LYSARC, the operational structure of the cooperative group LYSA, is standardizing clinical processes with Vault CDMS, Vault CTMS, Vault eTMF, Vault Study Start-up, and Vault Payments, streamlining quality processes with Vault QMS, Vault QualityDocs, and Vault Training, and mitigating risk with Vault Safety. The organization will also encourage its network of partners to adopt Veeva SiteVault Free to enable seamless information sharing with site investigators and sponsors.

Additional Information
For more on Veeva Vault Development Cloud, visit: veeva.com/DevelopmentCloud Connect with Veeva on LinkedIn: linkedin.com/company/veeva-systems Follow @veevasystems on Twitter: twitter.com/veevasystems

On January 20, 2022 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, reported the results of two large scale clinical studies, which show that the company’s Nu.Q assays, when used in conjunction with the Fecal Immunochemical Test (FIT), can detect colorectal cancer and all high-risk advanced adenomas in symptomatic patients, and thereby reduce unnecessary colonoscopies (Press release, VolitionRX, JAN 20, 2022, View Source [SID1234605651]). The studies also demonstrated that the company’s Nu.Q assays can improve the detection of high-risk adenomas in asymptomatic patients.

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Principal Investigator, Professor Han-Mo Chiu, National Taiwan University, said "We are enormously encouraged by the findings of these two studies. Not only do they show that using Nu.Q assays in combination with FIT can potentially reduce unnecessary colonoscopies by up to 28% in patients with gastrointestinal symptoms, the studies also show that this dual approach could be used more widely to improve the effectiveness of FIT-based screening programs targeting asymptomatic patients. We look forward to presenting our findings to colleagues at ASCO (Free ASCO Whitepaper) GI 2022."

Dr. Marielle Herzog, Research and Development Director at Volition, said "Early diagnosis is key to improving outcomes for patients with colorectal cancer, and cancer screening programs are critical to every public health system. The results of our studies, using Volition’s Nu.Q assays in conjunction with FIT, are incredibly encouraging, not only in reducing unnecessary colonoscopies but also in detecting high-risk adenomas, both proximal and distal, which FIT, when used alone can miss. We are excited about the next stage, facilitating an independent, prospective validation study later this year."

The studies were undertaken by Volition and the Department of Internal Medicine at the National Taiwan University Hospital and findings will be presented at the 2022 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, later this week.

Volition is developing simple, easy to use, cost-effective blood tests to help diagnose and monitor a range of life-altering diseases including cancer.

Colorectal cancer is the fourth most common cancer worldwide, with 1.9 million new cases in 2020, and accounts for over 9% of all cancer-related deaths each year¹. Population-based colorectal cancer screening programs are in place in many healthcare systems globally, and the most commonly recommended screening method² is the FIT, followed up with colonoscopy, an invasive visual examination. However, approximately 60% of FITs provide false-positive results³, leading to unnecessary and costly colonoscopies.

Posters to be presented at ASCO (Free ASCO Whitepaper) GI 2022 can be downloaded here:

1) Circulating nucleosomes levels improve FIT performance for detecting high-risk colorectal neoplasms in a symptomatic population.
2) Circulating nucleosomes for detection of colorectal cancer and high-risk advanced adenomas.

For more information about Volition’s Nu.Q technology go to: www.volition.com

Notes to editors:

References:

¹ World Health Organization International Agency for Research on Cancer (IARC). GLOBOCAN 2020: estimated cancer incidence, mortality and prevalence worldwide in 2020.

² Schliemann, D., Ramanathan, K., Matovu, N. et al. The implementation of colorectal cancer screening interventions in low-and middle-income countries: a scoping review. BMC Cancer 21, 1125 (2021).

³ Chiu HM, Chen SL, Yen AM, et al. Effectiveness of fecal immunochemical testing in reducing colorectal cancer mortality from the One Million Taiwanese Screening Program. Cancer. 2015;121(18):3221-3229.

About the studies

476 patients referred for surveillance colonoscopy or secondary to bowel symptom were enrolled: (i) CRC (n= 67), (ii) advanced adenoma (AA) (n=60), non-AA (n=123); (iv) non-neoplastic polyps (n=29); (vi) colonoscopy negative (controls) (n=197).
520 average-risk asymptomatic patients: (i) CRC (n= 33), (ii) advanced adenoma (AA) (n=123, including 18 with AA>2cm); (iii) non-AA (n=168); (iv) non-neoplastic polyps (n=30); (vi) colonoscopy negative control (n=166).
Plasma and stool samples were obtained prior to colonoscopy.
Circulating Nucleosome levels measured using Volition’s Nu.Q quantitative immuno-assays.
FIT: OC-SENSOR (Eiken Chemical Co., Ltd., Tokyo, Japan) using a positive cut-off of 20ug/g feces.

On January 20, 2022 Viewpoint Molecular Targeting, Inc. ("Viewpoint" or the "Company"), a radiopharmaceutical company developing precision lead-212-based α-particle oncology therapeutics and complementary diagnostic imaging agents, reported that Frances L. Johnson, MD, Chief Executive Officer will participate in the Virtual Investor 2022 Top Picks Conference on Tuesday, January 25, 2022 at 11:00 AM ET (Press release, Viewpoint Molecular Targeting, JAN 20, 2022, https://viewpointmt.com/viewpoint-molecular-targeting-to-present-at-the-virtual-investor-2022-top-picks-conference/ [SID1234605650]).

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As part of the virtual event, the Company will provide a corporate presentation followed by a moderated interactive Q&A session. In addition to the moderated portion of the event, all investors and interested parties will have the opportunity to submit live questions. Interested parties may also submit questions in advance of the live event, which can be sent via the conference website at virtualinvestorco.com. The Company will answer as many questions as possible during the event.

A live video webcast of the Roundtable Event will be available on the Events page of the Company’s website (viewpointmt.com). A webcast replay will be available two hours following the live presentation and will be accessible for one year.

On January 20, 2022 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported that John Climaco, Chief Executive Officer of CNS Pharmaceuticals, will participate in the Virtual Investor 2022 Top Picks Conference on Wednesday, January 26, 2022 at 11:00 AM ET (Press release, CNS Pharmaceuticals, JAN 20, 2022, View Source [SID1234605647]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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As part of the virtual event, the Company will provide a corporate presentation, followed by a moderated interactive Q&A session. In addition to the moderated portion of the event, all investors and interested parties will have the opportunity to submit questions live during the event. Interested parties may also pre-submit questions in advance of the live event, which can be sent via the conference website at virtualinvestorco.com. The Company will answer as many questions as possible during the event.

A live video webcast of the presentation will be available on the Events page of the Investors section of the Company’s website (cnspharma.com). A webcast replay will be available two hours following the live presentation and will be accessible for one year.

On January 20, 2022 NeoDynamics AB (Spotlight Stock Market: NEOD), a medtech company dedicated to advancing diagnosis and care of breast cancer, reported it will present results from the PULSE study illustrating the benefits of the novel biopsy device NeoNavia in challenging axillary lymph nodes, at the SBI/ACR Breast Imaging Symposium in Savannah, Georgia, taking place on May 16-19 (Press release, NeoDynamics, JAN 20, 2022, View Source [SID1234605645]). The symposium is held to be the most important annual meeting for US breast imaging professionals.

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A subgroup analysis from the ethically approved German prospective multi-center study PULSE (ClinicalTrials.gov ID: NCT03975855), shows that the biopsy device NeoNavia was safe and effective for percutaneous tissue sampling also in axillary lymph nodes presenting parameters indicating high anatomic complexity and procedural difficulty. The system’s pulses were perceived to stabilize the target lesion and provide needle control during insertion. It was also possible to obtain multiple samples with a single insertion.

The scientific abstract has been accepted for oral presentation at the symposium. The presentation will be carried out by the Principial Investigator, Prof. Marc Thill, AGAPLESION MARKUS KRANKENHAUS Frankfurt, under the title "New pulse biopsy device safe and effective in challenging cases of axillary biopsies: Subgroup analysis of initial PULSE data for lymph nodes of small size and difficult anatomic location".

"The NeoNavia device has demonstrated great performance in the most challenging subgroup of cases in the PULSE study. Management of the axilla in breast cancer patients continues to be a hot topic. Needle biopsies enable an early assessment of whether the cancer has spread to the axillary lymph nodes at the time of breast cancer diagnosis. This information facilitates optimal treatment planning which is crucial for patient outcomes. A biopsy device that increases sampling yield and improves insertion control is very well suited to set a new standard in this area. With performance documented for challenging biopsies in the axillary lymph nodes, we are now looking forward to using the further improved next generation NeoNavia biopsy system in our patients to improve the diagnosis of breast cancer," says Prof. Marc Thill.

The SBI/ACR Breast Imaging Symposium is the most important annual meeting for breast imaging professionals in the US, usually attracting over 1 000 participants. NeoDynamics plans to file for registration of NeoNavia in the US during the first quarter 2022.

NeoNavia is an innovative biopsy system built on a patented pulse technology for controlled and precise needle insertion and is based on research at the Karolinska Institutet in Sweden. A pneumatic hand-held driver is driven by a base unit and pulses are activated by pressing a button. With the help of these pulses, the biopsy needle is advanced in steps of 1-2 mm, allowing a distinct, stepwise needle insertion into the tissue and a precise placement of the needle in the suspected lesion.

For further information, please contact:

Anna Eriksrud, CEO NeoDynamics AB, phone +46708 444 966 or e-mail [email protected]

Kai-Uwe Schässburger, Ph.D. Director Clinical Development & Medical Affairs, phone +46 762 386 153 or + 49 151 688 092 41