On April 21, 2021 RhoVac AB ("RhoVac"), a Swedish cancer immunotherapy company, reported, April 21st 2021, that the prestigious Mount Sinai hospital in New York is initiated as the latest addition to US trial centres in RhoVac’s clinical phase IIb study, "BRaVac", in prostate cancer (Press release, RhoVac, APR 21, 2021, View Source [SID1234578319]).

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Mount Sinai Hospital, founded in 1852, is one of the oldest and largest teaching hospitals in the United States, and it is widely recognised and one of the leading hospitals in the US, and indeed in the world, and as such RhoVac is extremely proud to declare its participation in the BRaVac trial.

The participation of Mount Sinai was directly caused by the FDA approval of RhoVac’s Fast Track Designation. Immediately after the news on the Fast Track Designation was made public, Mount Sinai contacted RhoVac via its Scientific Advisory Board member, Professor Per-Anders Abrahamsson, who brokered the connection to RhoVac management. It is an honour for RhoVac, and a recognition of the potential of its drug candidate, that such a world leading hospital spontaneously seeks to join its clinical trial.

The site initiation visit is held, today, April 21st , and the study will be supervised at Mount Sinai by Professor Ash Tewari. In the trial, RhoVac’s drug candidate, RV001, will be used in prostate cancer patients that have previously had a prostatectomy or definitive radiation therapy, but that now have suffered a "Biochemical Recurrence" (rising PSA) but who still have not developed detectable metastases. The objective of the development of RV001 is to prevent/delay the recurrence of cancer and its progression to a metastatic state. If a clinical proof of concept is obtained in prostate cancer, several other cancer indications would also be candidates for development.

RhoVac CEO, Anders Månsson, comments: "I was of course delighted when I learned that Mount Sinai wanted to join our study. I regard this as yet another example of the recognition that the Fast Track Designation has brought us already, and I am happy that we could get started so quickly. I wish Mount Sinai welcome on board the trial team, and I look forward to our collaboration".

On April 21, 2021 Ampio Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, reported it will host a conference call to discuss financial results for the quarter ended March 31, 2021 and provide a corporate business update on Wednesday, May 5, 2021 at 4:30pm EDT/ 2:30pm MT (Press release, Ampio, APR 21, 2021, View Source [SID1234578318]).

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The conference call will also be available from the Investor Relations section of the Company’s website at www.ampiopharma.com and will be archived there shortly after the live event.

On April 21, 2021 Alkermes plc (Nasdaq: ALKS) reported that it will host a conference call and webcast presentation at 8:00 a.m. ET (1:00 p.m. BST) on Wednesday, Apr. 28, 2021 to discuss the company’s first quarter 2021 financial results (Press release, Alkermes, APR 21, 2021, https://www.prnewswire.com/news-releases/alkermes-to-host-conference-call-to-discuss-first-quarter-2021-financial-results-301274155.html [SID1234578317]). Management will also provide an update on the company.

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The webcast player and accompanying slides may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers.

A replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. BST) on Wednesday, Apr. 28, 2021, through Wednesday, May 5, 2021, and may be accessed by visiting Alkermes’ website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay access code is 13718854.

On April 21, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported it will release its first quarter 2021 financial results after the market closes on Wednesday, May 5, 2021 (Press release, Personalis, APR 21, 2021, View Source [SID1234578315]). In conjunction with the release, the Company will host a conference call and webcast that day at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss its financial results and recent highlights.

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Interested parties may access the live call via telephone by dialing (866) 220-8061 for domestic callers or (470) 495-9168 for international callers, using conference ID: 6587766. The live webinar of the call may be accessed by visiting the Events section of the company’s website at investors.personalis.com. A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.

On April 21, 2021 Scientists at City of Hope, a world-renowned independent research and treatment center for cancer and diabetes, reported that have developed a novel, noninvasive liquid biopsy test for detecting lymph node metastasis in individuals with high-risk T1 colorectal carcinoma (Press release, City of Hope, APR 21, 2021, View Source [SID1234578314]). Research on the development of the blood test was reported in a new study published in Gastroenterology, a journal of the American Gastroenterological Association.

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This blood-based test is an example of the theranostic (a term that combines "therapeutic" and "diagnostic") approach at City of Hope, whose goal is to help every patient receive personalized treatment appropriate for their specific disease. Development of blood-based biopsies to detect and monitor tumors is one of the leading-edge technologies under investigation to help patients with cancer.

Most individuals suspected of having T1 colorectal cancer with lymph node metastasis undergo radical surgery to remove affected parts of the colon. Unfortunately, only 5-10% of these individuals actually had lymph node metastasis after final examination of the removed colon, indicating that surgery was not necessary for the majority of these people.

"Since radical surgery dramatically reduces quality of life for patients, improving the success rate of identification of high-risk individuals with lymph node metastasis remains the challenge in T1 colorectal cancer diagnosis," said Ajay Goel, Ph.D., M.S., chair of the Department of Molecular Diagnostics and Experimental Therapeutics at City of Hope, and the study’s senior author. "In the future, we hope to improve our confidence in identifying which individuals truly have lymph node metastasis via this novel biomarker-based liquid biopsy test for T1 colorectal cancer, in combination with clinical and pathological criteria."

The publication by Goel and colleagues focused on translating their previous findings of identifying lymph node metastasis with T1 colorectal cancer in a tissue-based assay into a blood-based assay. After refining and validating the panel of RNA biomarkers, the blood test was found to accurately identify lymph node metastasis with high sensitivity (83.3%; a higher value means fewer cases of disease are missed), and specificity (76.2%; a higher value means the test can accurately identify those without disease).

"Obtaining results with more than 80% accuracy (sensitivity) in finding lymph node metastasis in the blood was a completely unexpected finding and is a complete game changer," Goel said.

City of Hope researchers are excited about the potential of this new liquid biopsy test to complement current risk assessment for lymph node metastasis for individuals with early stage T1 colorectal cancer. The technology is patent pending.

Goel indicated that further work will be done to optimize the blood-based assay to improve sensitivity and continue to validate the assay in prospective clinical trials. "There are several steps between where we are now and where we want to go — detecting lymph node metastasis in colon cancer from a blood sample — but without doubt this is an encouraging first step."

Support for this study was provided by grants from the National Cancer Institute, and the National Institutes of Health (CA72851, CA181572, CA184792, CA202797 and CA187956).