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Stand Up To Cancer Announces First-of-Its-Kind Initiative to Increase Diversity in Cancer Clinical Trials

On January 27, 2020 Stand Up To Cancer (SU2C) reported a groundbreaking initiative to increase minority representation in cancer clinical trials (Press release, SU2C, JAN 27, 2020, View Source [SID1234553611]). All future SU2C-supported research grant proposals will now be required to include and address crucial issues related to recruitment and retention of patients from ethnic groups to improve diverse participation in cancer clinical trials. The announcement was made at Stand Up To Cancer’s annual Scientific Summit, which is attended by SU2C’s leadership and 300+ prominent cancer researchers representing each of SU2C’s Dream Teams, Research Teams and individual grants.

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The lack of diverse participation in cancer clinical trials has been ongoing for decades, largely due to socio-economic, cultural, trust and other barriers.

"As one of the leading funders of cancer research, we believe it is our duty to ensure that minority representation in cancer clinical trials is addressed. Now, more than ever, better understanding of the role of biology in cancer treatment, advances in precision treatment, and development of new technologies demands that we also make significant improvements in diverse clinical trial participation," said SU2C CEO Sung Poblete, PhD, RN. "We are confident that this initiative will make a significant and meaningful impact to ensure all communities have equal access to potentially life-saving treatments."

Despite an overall decline in U.S. cancer deaths since 1991, not all patients have benefited equally from advances in prevention, early detection, precision medicine and targeted cancer treatments. According to the U.S. Food and Drug Administration, currently only four percent of clinical trial participants are black, and four percent are Hispanic, and 15 percent are Asian, despite minority groups overall in the U.S. having both the highest death rate and shortest survival rate for most cancers.

SU2C’s Committee for Health Equity in Cancer Clinical Trials in collaboration with SU2C scientific leadership, has developed procurement language that will now be used to solicit proposals for SU2C Dream Teams, Research Teams and other grants in the SU2C research portfolio to increase diverse participation in cancer clinical trials. SU2C now requires applicants for funding to include three critical components related to health equity:

an indication of whether the research will address the populations expected to benefit from widespread use of newly developed treatments;
patient recruitment and retention plans for including historically underrepresented racial and ethnic populations – such as the need for additional trial sites or mechanisms to reduce barriers to access; and
a letter of support from the lead institution’s Chief Diversity Officer, or an equivalent position.
By requiring these to be included in all proposals submitted moving forward, these factors will also be considered both in SU2C’s rigorous selection process, and as part of grant performance evaluation conducted in SU2C’s formal semi-annual reviews.

In addition, Stand Up To Cancer announced plans to fund up to $6.4MM for the SU2C Health Equity Breakthroughs Research Team researching cancers affecting underrepresented populations, supported by a transformational grant from Genentech, a member of the Roche Group. SU2C is expected to issue the [Request for Applications seeking proposals later in the first quarter of 2020. Proposals may address cancers that have a higher prevalence in a specific racial or ethnic population; cancers that are more deadly among specific minority populations; or may address the need for more effective treatments for specific cancers for patients of diverse backgrounds.

"Genentech is committed to improving the health and well-being of all patients, which means ensuring that scientific research and innovative treatment options are developed for every individual," said Quita Highsmith, Chief Diversity Officer at Genentech. "We are honored to partner with SU2C to support groundbreaking research that promotes health equity while working to revolutionize cancer care."

The SU2C Health Equity Breakthroughs Research Team will be selected and launched in 2020. For information, or to receive the Call for Ideas when it is issued, please visit "Funding Opportunities." To learn more about Genentech’s efforts in this area, please visit "Advancing Inclusive Research."

At the Summit, Stand Up To Cancer also introduced the new international SU2C Gastric Cancer Interception Research Team, which includes investigators from Harvard Medical School and Massachusetts General Hospital Cancer Center; University of Pennsylvania’s Perelman School of Medicine; University of Chicago; City of Hope Comprehensive Cancer Center; Memorial Sloan Kettering Cancer Center and Samsung Medical Center (South Korea).

While gastric (stomach) cancer is the third-leading cause of cancer death worldwide, it is more common in black, Hispanic, and Asian people than in white populations. New ways are needed to detect these cancers early, when they can be successfully treated. This $3MM Research Team is conducting intensive studies to identify biomarkers, such as particular bits of DNA, and cells shed from the tumor that circulate in the blood system and indicate the presence of gastric cancer. Team members have developed a new detection technology, extending the use of a pill-sized camera that can be swallowed by the patient using a new marker to "light up" cancer cells, allowing the camera to capture images of stomach tissue at risk of developing cancer. If validated in a clinical trial, these methods will help doctors screen people in groups at risk of gastric cancer. To learn more about the SU2C Gastric Cancer Interception Research Team, visit View Source

"By having Research Teams dedicated to cancers that correlate to, or greatly affect, different racial and ethnic populations, we’ll be able to ensure that strides are being made in cancers that typically affect these populations," said Edith A. Perez, MD, chairperson of the SU2C Committee for Health Equity in Cancer Clinical Trials. "Support for these teams further demonstrates our commitment to bringing breakthrough therapies to historically underrepresented racial and ethnic groups and improving overall health equity in cancer research. We are proud and excited to play such a large role in serving this unmet need and look forward to setting the tone for scientific research to come."

Dr. Poblete also noted that SU2C will be collaborating with the Black Women’s Health Imperative (BWHI) and Friends of Cancer Research in Project TEACH: Trained Empowered Advocates for Community Health (Healing), funded by the Patient-Centered Outcomes Research Institute (PCORI). Through education and outreach, this nationwide project will empower black women to effectively engage with researchers and clinicians, and to increase participation of black women in cancer-focused clinical trials.

PharmaMar and Bionical Emas Launch Expanded Access Program for Lurbinectedin in Relapsed Small Cell Lung Cancer in the U.S.

On January 27, 2020 PharmaMar (PHM:MSE) and Bionical Emas, a global specialist Clinical Research Organization (CRO) have reported the launch of an Expanded Access Program (EAP) for lurbinectedin to treat patients in the United States (U.S.) with relapsed Small Cell Lung Cancer (SCLC), who are unable to enter clinical trials and there are no appropriate alternative treatments (Press release, PharmaMar, JAN 27, 2020, View Source [SID1234553610]).

Dr. Jack West, Associate Clinical Professor, City of Hope Cancer Center, Duarte, CA, said: "I welcome the availability of lurbinectedin through the EAP as an option for patients. This disease has few compelling alternatives in this setting, so this would be a very welcome option for physicians and patients alike."

SCLC is a very aggressive cancer that is usually diagnosed with advanced, often metastatic disease, thus limiting the role of traditional approaches and usually posing a worse prognosis when compared to other lung cancers1. In the U.S., approximately 10-15% of lung cancers are small cell1. Approximately 30,000 new cases of SCLC are recorded in the U.S. every year2. The treatment of relapsed SCLC has not changed substantially in more than two decades.

SCLC is one of PharmaMar’s priority research areas. In December 2019, the Company announced the filing of lurbinectedin’s New Drug Application (NDA) for the treatment of relapsed SCLC with the FDA under the "accelerated approval" program.

"SCLC is a devastating disease for patients and their families, having limited effective treatment options. We are excited to be able to provide access to lurbinectedin to eligible patients across the U.S.," said Tom Watson, Executive Vice President, Bionical Emas.

"I am happy to see the launch of the lurbinectedin EAP in the U.S. today. Relapsed SCLC is a very aggressive disease with existing second line treatments showing only limited effectiveness. As oncology physicians, we are constantly looking for new treatment options for our patients. There is only one approved drug for the second line treatment which has modest benefit and significant side effects, and there are currently no other open EAPs. Providing access to this new option for patients requires time and investment from the Company and it is greatly appreciated by physicians in the clinic," said Dr. William Jeffrey Petty, Professor, Hematology and Oncology, Wake Forest Baptist Health, Winston-Salem, North Carolina.

Healthcare professionals wishing to request access to lurbinectedin under the EAP or who would like to find out more should do so by emailing [email protected].

Arix Co-founds Quench Bio With Series A Financing

On January 27, 2020 Arix Bioscience plc ("Arix", LSE: ARIX) a global venture capital company focused on investing in and building breakthrough biotech companies, reported that its discovery portfolio company Quench Bio has emerged from stealth mode with the completion of a Series A financing (Press release, Arix Bioscience, JAN 27, 2020, View Source [SID1234553601]). This follows a period of company creation, with seed investment and close involvement by Arix.

Led by a team of drug developers and scientists with deep experience in inflammation and small molecule drug discovery, Quench Bio’s lead therapeutic approach centres on inhibiting the protein Gasdermin D, which has recently been discovered as a key target at the core of multiple inflammatory cell death pathways, including pyroptosis and NETosis. This is at the cutting edge of contemporary drug development and a field of significant commercial interest by big pharma.

The company has built a highly experienced leadership team, led by Chief Executive Officer Samantha Truex, the former Chief Business Officer of Padlock Therapeutics, which was acquired by Bristol Myers Squibb in 2016.

Arix and Atlas Venture co-founded and seeded the company in 2018 along with co-founders Mark Tebbe, Ph.D., Chief Technology Officer, and Mike Nolan, Ph.D., Head of Biology, together with Arturo Zychlinsky and Herbert Waldmann, both Directors at The Max Planck Institute who collaborated with the Lead Discovery Center on inhibitors of NETosis and gasdermin.

In addition to Arix and its co-founding investor Atlas Venture, RA Capital led the Series A and were joined by AbbVie Ventures. Josh Resnick, Managing Director and co-head of Ventures at RA Capital and Adam Houghton, Head of AbbVie Ventures will join the board, alongside existing directors Jonathan Tobin of Arix Bioscience and Bruce Booth of Atlas Venture. Additionally, Arix’s John Cassidy will continue his role as Board Observer.

Jonathan Tobin, Investment Director at Arix and Board Director of Quench Bio, commented: "We are excited and privileged to work alongside such a distinguished team of entrepreneurs and co-investors to develop first-in-class medicines that could make a major difference to patients suffering from chronic inflammatory and auto-immune diseases. The genesis of Quench originated from our long-standing relationship with the Lead Discovery Center in Germany and its close connections with the Max Planck Society. It exemplifies the advantage of Arix’s transatlantic approach, combining the best of European and US science and talent."

Samantha Truex, Chief Executive Officer of Quench Bio, commented: "The successful financing underscores the potential of our innovative approach. We are delighted by the strong support from Arix as well as our existing and new investors and I look forward to leveraging their extensive experience as we develop multiple programs to target severe inflammatory diseases."

Select Medical Holdings Corporation Announces Business Outlook for 2020 and Release Date for Fourth Quarter and Full Year 2019 Financial Results

On January 27, 2020 Select Medical Holdings Corporation ("Select Medical") (NYSE: SEM), reported its business outlook for calendar year 2020 (Press release, Select Medical, JAN 27, 2020, View Source [SID1234553600]).

Select Medical expects consolidated net operating revenues for the full year 2020 to be in the range of $5.575 billion to $5.675 billion. Select Medical expects net income before interest, income taxes, depreciation and amortization, stock compensation expense, other income/(expense), and equity in earnings/(losses), or Adjusted EBITDA for the full year 2020 to be in the range of $725 million to $760 million. Select Medical expects fully diluted income per common share for the full year 2020 to be in the range of $1.27 to $1.46.

Select Medical assumed total shares outstanding of 134.5 million when preparing the above business outlook for 2020. This share count includes unvested restricted shares, which have participation rights and are allocated an equitable portion of earnings under the two-class method for calculating income per common share.

The following is a reconciliation of full year 2020 Adjusted EBITDA expectations as computed to the low and high points of the range to the closet comparable GAAP financial measure. Refer to Select Medical’s most recent Form 10-Q filing for a discussion of Select Medical’s use of Adjusted EBITDA in evaluating financial performance and determining resource allocation. Each item presented in the table below is an estimation of full year 2020 expectations (dollars in millions).

Select Medical will release the financial results for its fourth quarter and full year ended December 31, 2019 on Thursday, February 20, 2020 after the market closes.

Select Medical will host a conference call regarding its fourth quarter and full year ending December 31, 2019 results on Friday, February 21, 2020 at 9:00am ET. The domestic dial in number for the call is 1-866-440-2669. The international dial in number is 1-409-220-9844. The conference ID for the call is 8644656. The conference call will be webcast simultaneously and can be accessed at Select Medical Holdings Corporation’s website www.selectmedicalholdings.com.

For those unable to participate in the conference call, a replay will be available until 12:00pm ET, February 28, 2020. The replay number is 1-855-859-2056 (domestic) or 1-404-537-3406 (international). The conference ID for the replay will be 8644656. The replay can also be accessed at Select Medical Holdings Corporation’s website, www.selectmedicalholdings.com.

Select Medical is one of the largest operators of critical illness recovery hospitals, rehabilitation hospitals, outpatient rehabilitation clinics, and occupational health centers in the United States based on the number of facilities. Our reportable segments include the critical illness recovery hospital segment, the rehabilitation hospital segment, the outpatient rehabilitation segment, and the Concentra segment. As of December 31, 2019, Select Medical operated 101 critical illness recovery hospitals in 28 states, 29 rehabilitation hospitals in 12 states, and 1,740 outpatient rehabilitation clinics in 37 states and the District of Columbia. Select Medical’s joint venture subsidiary Concentra operated 521 occupational health centers in 41 states. Concentra also provides contract services at employer worksites and Department of Veterans Affairs community-based outpatient clinics. At December 31, 2019, Select Medical had operations in 47 states and the District of Columbia. Information about Select Medical is available at www.selectmedical.com.

Certain statements contained herein that are not descriptions of historical facts are "forward-looking" statements (as such term is defined in the Private Securities Litigation Reform Act of 1995). Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements due to factors including the following:

changes in government reimbursement for our services and/or new payment policies may result in a reduction in net operating revenues, an increase in costs, and a reduction in profitability;
the failure of our Medicare-certified long term care hospitals or inpatient rehabilitation facilities to maintain their Medicare certifications may cause our net operating revenues and profitability to decline;
the failure of our Medicare-certified long term care hospitals and inpatient rehabilitation facilities operated as "hospitals within hospitals" to qualify as hospitals separate from their host hospitals may cause our net operating revenues and profitability to decline;
a government investigation or assertion that we have violated applicable regulations may result in sanctions or reputational harm and increased costs;
acquisitions or joint ventures may prove difficult or unsuccessful, use significant resources or expose us to unforeseen liabilities;
our plans and expectations related to our acquisitions and our ability to realize anticipated synergies;
private third-party payors for our services may adopt payment policies that could limit our future net operating revenues and profitability;
the failure to maintain established relationships with the physicians in the areas we serve could reduce our net operating revenues and profitability;
shortages in qualified nurses, therapists, physicians, or other licensed providers could increase our operating costs significantly or limit our ability to staff our facilities;
competition may limit our ability to grow and result in a decrease in our net operating revenues and profitability;
the loss of key members of our management team could significantly disrupt our operations;
the effect of claims asserted against us could subject us to substantial uninsured liabilities;
a security breach of our or our third-party vendors’ information technology systems may subject us to potential legal and reputational harm and may result in a violation of the Health Insurance Portability and Accountability Act of 1996 or the Health Information Technology for Economic and Clinical Health Act; and
other factors discussed from time to time in our filings with the Securities and Exchange Commission (the "SEC"), including factors discussed under the heading "Risk Factors" of the quarterly reports on Form 10-Q and of the annual report on Form 10-K for the year ended December 31, 2018.
Except as required by applicable law, including the securities laws of the United States and the rules and regulations of the SEC, we are under no obligation to publicly update or revise any forward-looking statements, whether as a result of any new information, future events, or otherwise. You should not place undue reliance on our forward-looking statements. Although we believe that the expectations reflected in forward-looking statements are reasonable, we cannot guarantee future results or performance.

Cannabics Pharmaceuticals Study Shows Cannabinoids CBC and CBG Exhibit Anti-Tumor Properties on Gastrointestinal Cancer Cells

On January 27, 2020 Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a leader in personalized cannabinoid medicine focused on cancer and its side effects, reported that in a series of tests conducted at the company’s High Through-put Screening (HTS) facility in Israel, it has been shown that the cannabinoids CBC (Cannabichromene) and CBG (Cannabigerol) both exhibit anti-tumor properties, tested on human Gastrointestinal Cancer Cells (Press release, Cannabics Pharmaceuticals, JAN 27, 2020, View Source [SID1234553599]).

Cannabinoid extract causing necrosis in Gastrointestinal cancer cell line. The Yellow color is a marker for necrosis. On the right – control, on the left – after treatment with cannabinoids
Cannabinoid extract causing necrosis in Gastrointestinal cancer cell line. The Yellow color is a marker for necrosis. On the right – control, on the left – after treatment with cannabinoids
CBC is an additional non-psychoactive cannabinoid and is one of the naturally occurring Phyto-cannabinoids. It bears a host of potential positive therapeutic qualities and may promote antimicrobial, anti‐inflammatory, analgesic, and neurogenesis activity. It is particularly found in younger Cannabis plants, albeit in small quantities.

In these tests, the HTS platform was utilized to screen the necrotic effects of a variety of cannabinoids on human Gastrointestinal cancer cells, in addition to other cancer types previously tested. CBC and CBG were both shown to induce significantly higher rates of necrosis in these cancer cells compared to other cannabinoids, thus strengthening previously obtained results.

Dr. Yaakov Waksman, the company’s head of cannabidiol research, said, "My working assumption is that these results show that a correlation may exist between a cannabinoid’s Topological Polar Surface Area (TPSA) value and its ability to induce anti-tumor activity, diminishing cancer cell’s viability rates. CBC and CBG, as neutral cannabinoids, were both found to have a TPSA value which allows the cannabinoid molecule to penetrate a cancer cell’s membrane, whereas their acidic form (CBCA and CBGA) – do not. This could explain the difference in anti-tumor activity rates demonstrated".

Dr. Eyal Ballan, CTO and Co-Founder, commented, "Gastrointestinal cancers are amongst the leading and most wide-spread causes of cancer-related deaths worldwide. We are intrigued by the results we have obtained in the lab, and our aim is to consider placing an emphasis on this organ system, and to further explore the differential anti-tumor properties of cannabinoids. We believe that these preliminary results vindicate our vision; which is to bring personalization into cannabinoid-based cancer treatments."