On February 12, 2020 miR Scientific LLC, reported that it will present the results of the recently completed Case-Control validation study of 1,436 patients consisting of 836 patients in a fully cross-validated training group and independent testing group of 600 patients (Press release, miR Scientific, FEB 12, 2020, View Source [SID1234554246]). The podium presentation will be in Oral Abstract Session A: Prostate Cancer at 1:10 p.m. on Thursday, February 13, 2020 and is titled Abstract 277: Analysis of small non-coding RNAs in urinary exosomes to classify prostate cancer into low-grade (GG1) and higher-grade (GG2-5).

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The study describes the miR Scientific Sentinel Disease Management Platform for Prostate Cancer which currently consists of three tests: The Sentinel PCa Test, that determines the presence or absence of prostate cancer, the Sentinel CS Test which identifies patients with low grade (GG1) or intermediate and high grade (GG2-GG5) prostate cancer and the Sentinel HG Test that identifies patients with high grade, high-risk cancer. Each test examines the expression levels of small non-coding RNAs (sncRNAs) extracted from urinary exosomes to diagnose, classify and monitor prostate cancer. The company’s classification algorithms identify and interrogate between 200-280 small non-coding RNAs using a customized, high throughput qPCR OpenArray platform for each test.

The results of the validation study demonstrate that the Sentinel PCa Test has a sensitivity of 94% and a specificity of 92%; the Sentinel CS Test has a sensitivity of 93% and a specificity of 90%; and the Sentinel HG Test has a sensitivity of 94% and a specificity of 96%. The performance characteristics of these tests support the company’s efforts to introduce the miR Scientific Disease Management Platform to mitigate poor outcomes and waste for patients and all key stakeholders, including healthcare providers, employers and payors. This validation now enables stakeholders to engage as early adopters worldwide. The combination of the three tests, which are standalone, do not require nor rely on any other testing nor risk analysis and can be performed on a single urine sample, providing a very precise platform for disease management, with high utility for diagnosing, classifying and monitoring prostate cancer.

"The results presented at ASCO (Free ASCO Whitepaper) GU demonstrate that the miR Scientific Sentinel Tests can transform clinical practice with broadly new and powerful capabilities to directly classify patients into actionable pathways: those with no evidence of prostate cancer, patients in need of definitive treatment, and patients eligible for active surveillance, which the Sentinel Tests can monitor," said Sam Salman, Chairman & CEO of miR Scientific. "The accuracy demonstrated by the miR Scientific Sentinel tests is significantly better than that of other current technologies and could prove to be even more accurate as we are currently ascertaining what proportion of this discordance represents misattribution of core needle biopsy histopathology or genuine misclassification errors of the Sentinel Tests. miR Scientific believes that the results suggest that the non-invasive Sentinel tests can be used as part of the Sentinel Prostate Cancer Disease Management Platform to provide patients and health care providers with an unprecedented level of information, allowing for more accurate and effective treatment of these cancers."

Renowned practitioners have expressed their confidence in these results. "The burden of over diagnosis and unnecessary treatments in prostate cancer worldwide is well known. What has been lacking is an effective, non-invasive tool to identify which patients may harbor aggressive cancers that are life threatening. The miR Scientific platform of liquid biopsy represents a highly sensitive and accurate way to identify these patients with less need for invasive procedures," said James M. McKiernan, M.D., the John K. Lattimer Professor and Chairman of the Department of Urology at Columbia University College of Physicians and Surgeons, Urologist in Chief, New York Presbyterian Hospital.

On February 12, 2020 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported the commencement of a registered underwritten public offering of $250.0 million in shares of its common stock (Press release, Deciphera Pharmaceuticals, FEB 12, 2020, View Source [SID1234554213]). In addition, Deciphera intends to grant the underwriters a 30-day option to purchase up to $37.5 million in shares of its common stock.

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J.P. Morgan, Piper Sandler and Jefferies are acting as joint book-running managers for the offering. Guggenheim Securities is acting as lead manager for the offering. SunTrust Robinson Humphrey is acting as co-manager for the offering.

Deciphera intends to use the net proceeds from the offering to fund general corporate purposes, which may include research and development and clinical development costs to support the advancement of its drug candidates, including the continued growth of its commercial and medical affairs capabilities to support its transition from a development-stage company toward a commercial-stage company; the conduct of clinical trials and preclinical research and development activities; working capital; capital expenditures; general and administrative expenses; and other general corporate purposes.

An automatic shelf registration statement (including a prospectus) relating to the shares of common stock offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) on February 12, 2020 and became effective upon filing. The securities may be offered only by means of a written prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from J.P. Morgan Securities LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, Attention: Prospectus Department, by telephone at (800) 747-3924 or by email at [email protected]; and Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On February 12, 2020 Exelixis, Inc. (Nasdaq: EXEL) reported that its fourth quarter and full year 2019 financial results will be released on Tuesday, February 25, 2020 after the markets close (Press release, Exelixis, FEB 12, 2020, View Source [SID1234554231]). At 5:00 p.m. EST / 2:00 p.m. PST, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update. Access to the event is available via the Internet from the company’s website.

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To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 855-793-2457 (domestic) or 631-485-4921 (international) and provide the conference call passcode 9168158 to join by phone.

A telephone replay will be available until 8:00 p.m. EST on February 27, 2020. Access numbers for the telephone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 9168158. A webcast replay will also be archived on www.exelixis.com for one year.

On February 12, 2020 Sirtex Medical, a leading manufacturer of targeted liver cancer therapies, reported a collaboration with MIM Software Inc., a leading global provider of practical imaging solutions in the fields of radiation oncology, radiology, nuclear medicine, neuroimaging and cardiac imaging (Press release, Sirtex Medical, FEB 12, 2020, View Source [SID1234554247]). Under the terms of the agreement, Sirtex’s specialized sales teams in the United States, Europe and other key global markets will offer MIM SurePlanTM LiverY90 software alongside the company’s SIR-Spheres Y-90 resin microspheres to improve treatment precision for patients with hepatic tumors.

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MIM SurePlan LiverY90 provides timesaving tools and post-treatment dosimetry for interventional radiologists and nuclear medicine physicians treating hepatic tumors with SIR-Spheres. The software allows physicians to quickly calculate the dose delivered by the microspheres to improve treatment decisions and patient care. The technology also incorporates CT, PET, SPECT and MRI scans simultaneously to deliver results on spheres deposition, coverage and absorbed dose, allowing physicians to make informed decisions faster about next steps.

In addition to sharing a mission to provide physicians the tools they need to treat cancers, Sirtex and MIM also share a commitment to provide patients the best care throughout the treatment journey.

"Given the overlap of their technology and our SIR-Spheres product, Sirtex and MIM have a long history of working alongside clinical care teams," said Kevin Smith, Chief Executive Officer of Sirtex. "Now as partners, we will be able to combine our expertise and resources to provide an even higher level of support to treat liver tumors. We are excited to see how this collaboration will benefit physicians and ultimately improve treatment outcomes for patients."

"We are proud and excited to partner with Sirtex, mainly because it will provide access to personalized dosimetry for a large number of patients across the globe," said Andrew Nelson, Chief Executive Officer of MIM Software Inc. "The treatment of liver tumors requires a multi-disciplinary approach, so it’s a natural evolution for companies like ours to partner to provide an even faster, higher level of support and resources to treatment teams."

In the United States, SIR-Spheres Y-90 resin microspheres received Premarket Approval (PMA) from the FDA and are indicated for the treatment of non-resectable metastatic liver tumors from primary colorectal cancer in combination with intrahepatic artery chemotherapy using floxuridine. SIR-Spheres Y-90 resin microspheres are approved for the treatment of inoperable liver tumors in Australia, the European Union, Argentina, Brazil, Canada and several countries in Asia, such as India and Singapore.

About Selective Internal Radiation Therapy (SIRT) using SIR-Spheres Y-90 resin microspheres
SIR-Spheres Y-90 resin microspheres is a prescription device for the treatment of inoperable liver tumors. SIRT is a minimally invasive treatment that delivers high doses of high-energy beta radiation directly to the tumors. SIRT is administered to patients by interventional radiologists and nuclear medicine physicians, who infuse millions of radioactive resin microspheres via a catheter into the liver arteries that supply blood to the tumors. By using the tumors’ blood supply, the microspheres selectively target liver tumors with a dose of radiation that is up to 40 times higher than conventional radiotherapy, while sparing healthy tissue.

On February 12, 2020 Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, reported that management will present at the 9th Annual SVB Leerink Global Healthcare Conference on Wednesday, February 26, 2020 at 9:30 a.m. Eastern Time in New York, NY (Press release, Arcus Biosciences, FEB 12, 2020, View Source [SID1234554232]).

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A live audio webcast of the presentation will be available by visiting the "Investors" section of the Arcus website at www.arcusbio.com. A replay of the webcast will be available for at least 30 days following the live event.