Memorial Sloan Kettering’s Cycle for Survival Exceeds $250 Million for Rare Cancer Research

On February 19, 2020 Cycle for Survival, the movement to beat rare cancers, made history by topping $250 million raised since it was founded in 2007 (Press release, Memorial Sloan-Kettering Cancer Center, FEB 19, 2020, View Source [SID1234554526]). The grassroots fundraising effort includes donations from more than one million individuals across all 50 states. This milestone reflects the determination and generosity of a passionate community uniting to fight rare cancers. Every dollar raised goes to clinical trials, research studies and groundbreaking technologies pioneered by Memorial Sloan Kettering (MSK).

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MEMORIAL SLOAN KETTERING’S CYCLE FOR SURVIVAL EXCEEDS $250 MILLION FOR RARE CANCER RESEARCH With support from founding partner Equinox, the Cycle for Survival community surpasses a major fundraising milestone to help rare cancer patients with every dollar raised
MEMORIAL SLOAN KETTERING’S CYCLE FOR SURVIVAL EXCEEDS $250 MILLION FOR RARE CANCER RESEARCH With support from founding partner Equinox, the Cycle for Survival community surpasses a major fundraising milestone to help rare cancer patients with every dollar raised
Maximizing their success with the peer-to-peer fundraising model, Cycle for Survival has grown consistently over the past 14 years, with significant growth in the previous few years. More than half of the $250 million total was raised in the past three years.

Equinox, Cycle for Survival’s founding partner and host, has been essential to the fundraising achievements since the beginning. In celebration of the $250 million raised, Equinox provided a $500,000 donation match yesterday to help drive Cycle for Survival over the extraordinary quarter of a billion dollars mark.

In honor of this milestone, and to celebrate the 11th year of Cycle for Survival events in Chicago, Willis Tower lit its iconic antennas orange on February 8 during the local rides.

Starting as a single indoor cycling ride in New York City with just 230 people on 50 bikes, Cycle for Survival now has more than 37,000 participants on 9,000 bikes, and 250,000 donors annually. Participating teams include more than 1,100 corporate teams from 610 companies rallying colleagues to ride together. Cycle for Survival’s signature stationary cycling events, led by instructors from Equinox, take place in 17 cities across the country this January, February and March.

The $250 million raised by Cycle for Survival has allowed hundreds of MSK physicians, scientists and research teams to pursue bold ideas to change the way cancer is diagnosed and treated. Their investigations have made a direct impact on patient care, including FDA-approved drugs and effective experimental therapies. Cycle for Survival donations often provide vital seed funding for new research endeavors.

All of the money raised is allocated within the six months following the close of fundraising annually. The funds go directly to research and clinical trials for rare cancers, which affect about half of all cancer patients and include thyroid, brain, ovarian, pancreatic, all pediatric cancers and many others. As doctors and researchers pursue new treatments, Cycle for Survival provides urgently needed resources. Visit www.CycleforSurvival.org to learn more.

DelMar Pharmaceuticals [Nasdaq:DMPI] Enrolls Final Patient in Phase 2 Clinical Trial of VAL-083 For First-Line Treatment of Brain Tumors

On February 19, 2020 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported it has enrolled and begun dosing the final patient in its ongoing Phase 2 clinical study investigating the first-line treatment of VAL-083 with radiation therapy in newly-diagnosed, MGMT-unmethylated glioblastoma multiforme (GBM) (Press release, DelMar Pharmaceuticals, FEB 19, 2020, View Source [SID1234554493]). The trial, which is being conducted at the Sun Yat-sen University Cancer Center (SYSUCC) in Guangzhou, China, and in collaboration with Guangxi Wuzhou Pharmaceutical Company, is designed to enroll up to 30 patients to determine whether first-line therapy with VAL-083 treatment improves progression free survival (PFS). The current standard of care is first-line temozolomide (TMZ) with radiation.

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"We are very pleased to have enrolled and started dosing our final patient in this important study. This earlier than predicted full enrollment is encouraging and will allow an earlier topline data readout," commented Professor Zhong-ping Chen, founder chairman of the Department of Neurosurgery/Neuro-oncology at Sun Yat-sen University Cancer Center, and who is also the study’s principal investigator. "The enrollment of the final patient also provides us the opportunity to corroborate the preliminary data we’ve recently published, which supports the possibility that VAL-083 can provide a new and valuable treatment option in this difficult-to-treat indication."

The Phase 2 trial is a single-arm, open-label study testing VAL-083 in combination with standard radiotherapy in GBM patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene. The clinical trial in newly-diagnosed GBM patients is designed to determine if first-line treatment with VAL-083 plus radiotherapy can provide improvements over the historical efficacy of standard of care TMZ plus radiotherapy. Efficacy will be measured based on tumor response to treatment, progression-free survival, progression-free survival at six months, and overall survival compared to historical results in the target population.

"Having completed enrollment of our first-line study ahead of schedule, we expect to complete analysis for the topline data in our most important Phase 2 trial for first-line GBM patients earlier than anticipated. We are optimistic that we will receive the initial data readout before the end of August 2020," commented Saiid Zarrabian, DelMar’s Chief Executive Officer. "In the meantime, we continue to rapidly advance our other Phase 2 program in the adjuvant and recurrent settings for VAL-083 at MD Anderson Cancer Center and look forward to providing further updates on the progress of our ongoing open label GBM trials at upcoming scientific meetings."

DelMar has been monitoring the coronavirus situation in China. Based on discussions with our principal investigator at SYSUCC, we believe the coronavirus outbreak will not have a significant impact on our patient treatment timeline.

In addition to the Phase 2 clinical trial in first-line treatment, DelMar is conducting an additional two-arm Phase 2 clinical trial in GBM. The adjuvant arm, which initiated in late 2019 will enroll up to 24 newly-diagnosed patients who have undergone surgery and chemoradiation with TMZ but will now receive VAL-083 in place of standard of care TMZ for adjuvant therapy. The second arm treats patients with recurrent disease, administering VAL-083 in patients who have been heavily pre-treated with TMZ prior to disease recurrence. The recurrent arm will allow a total of 83 patients to be enrolled. Both arms are being conducted at the University of Texas MD Anderson Cancer Center.

About VAL-083

VAL-083 (dianhydrogalactitol) is a "first-in-class", bifunctional DNA-targeting agent that introduces inter-strand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM and ovarian cancer in historical clinical trials sponsored by the U.S. National Cancer Institute (NCI). DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by common mechanisms of chemoresistance, including MGMT, in cancer cell models and animal studies. Further details regarding these studies can be found at:

View Source

Bolt Biotherapeutics to Present at SVB Leerink 9th Annual Global Healthcare Conference

On February 19, 2020 Bolt Biotherapeutics, a private biotechnology company focused on using its Immune-Stimulating Antibody Conjugate (ISAC) platform technology to harness the power of the immune system to treat cancer, reported that Randall C. Schatzman, PhD., Chief Executive Officer, will present at the SVB Leerink 9th Annual Global Healthcare Conference on Tuesday, February 25, 2020 at 1:30 p.m. ET in New York, NY (Press release, Bolt Biotherapeutics, FEB 19, 2020, View Source [SID1234554527]).

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LIDDS: Second patient treated in the Phase I study, NZ-DTX-001

On February 19, 2020 LIDDS AB (publ) reported that the National Cancer Institute in Vilnius, Lithuania, has enrolled and dosed their first patient (Press release, Lidds, FEB 19, 2020, View Source [SID1234555855]). The aim of the phase I dose escalation clinical trial is to assess the tolerability and safety of intratumoral injections of NanoZolid with docetaxel, a well-established cytostatic used in the treatment of cancer with an estimated global market of over USD 1 billion.

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The NZ-DTX-001 study is a multi-center study including Karolinska University Hospital in Sweden, Herlev Hospital in Denmark, Kaunas University Hospital and Vilnius National Cancer Institute in Lithuania. The addition of three clinical sites is expected to result in much faster recruitment of patients.

– This project is very exciting as we hope that NanoZolid combined with docetaxel will decrease the tumor size and improve surgery and radiation therapy outcomes. In the Phase I study, LIDDS aims to demonstrate that intratumoral injections with cytostatic drugs are safe and we expect that following this study a wide range of different indications and NanoZolid combinations using chemotherapy drugs will emerge, says Monica Wallter, CEO.

– Our goal is to deliver drugs directly into the cancer tumor and thereby limit the severe side effects that cancer patients suffer from when receiving systemic chemotherapy treatments which affect all cells in the body including the immune system, says Monica Wallter.

Eagle Pharmaceuticals to Discuss Fourth Quarter and Full Year 2019 Financial Results on March 2, 2020

On February 19, 2020 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (Nasdaq: EGRX) reported that the Company will release its 2019 fourth quarter and full year financial results on Monday, March 2, 2020, before the market opens (Press release, Eagle Pharmaceuticals, FEB 19, 2020, View Source [SID1234554494]).

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Scott Tarriff, Chief Executive Officer, and Pete Meyers, Chief Financial Officer, will host a conference call to discuss the results as follows:

Date

Monday, March 2, 2020

Time

8:30 a.m. EST

Toll free (U.S.)

877-876-9173

International

785-424-1667

Webcast (live and replay)

www.eagleus.com, under the "Investor Relations" section

A replay of the conference call will be available for one week after the call’s completion by dialing 800-839-3020 (US) or 402-220-7234 (International) and entering conference call ID EGRXQ419. The webcast will be archived for 30 days at the aforementioned URL.