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RedHill Biopharma Announces Last Patient Visit in the Phase I Study With YELIVA(TM) (ABC294640) for Advanced Solid Tumors

On September 1, 2015 RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) ("RedHill" or the "Company"), an Israeli biopharmaceutical company primarily focused on late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal (GI) diseases, including gastrointestinal cancers, reported that the last patient has completed the final scheduled follow-up visit in the Phase I study evaluating YELIVA (ABC294640), the Company’s orally-administered first-in-class sphingosine kinase-2 (SK2) selective inhibitor, for the treatment of advanced solid tumors (the ABC-101 study) (Press release, RedHill Biopharma, SEP 1, 2015, View Source [SID:1234507372]).

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The ABC-101 Phase I study was conducted at the Medical University of South Carolina Hollings Cancer Center and was led by Principal Investigators Melanie Thomas, MD, and Carolyn Britten, MD. The open-label, dose-escalation, pharmacokinetic (PK) and pharmacodynamic (PD) first-in-human Phase I study of YELIVA (ABC294640) enrolled 22 patients with advanced solid tumors. The patients were continuously treated with the study drug in the absence of disease progression and evaluated for an additional period of up to one year after discontinuing treatment with YELIVA (ABC294640). The primary objectives of the study were to identify the maximum tolerated dose (MTD) and the dose limiting toxicities (DLTs) and to evaluate the safety of YELIVA (ABC294640). The secondary objectives of the study were to determine the pharmacokinetic (PK) and pharmacodynamic (PD) properties of YELIVA (ABC294640) and to assess its antitumor activity.

The study was supported by grants from the National Cancer Institute (NCI) and the FDA’s Office of Orphan Products Development (OOPD). Preliminary positive data from the Phase I study was presented by Apogee Biotechnology Corporation at the November 2013 Molecular Targets and Cancer Therapeutics meeting.

The analysis of the study is currently ongoing and top-line results are expected to be announced early in the fourth quarter of 2015. A full analysis and the final Clinical Study Report (CSR) are expected by the end of the year or early 2016.

YELIVA (ABC294640) is a proprietary, first-in-class, orally-administered sphingosine kinase-2 (SK2) selective inhibitor, with anti-cancer and anti-inflammatory activities, targeting multiple oncology, inflammatory and GI indications. SK2 is an innovative molecular target for anti-cancer therapy because of its critical role in catalyzing the formation of the lipid-signaling molecule sphingosine 1-phosphate (S1P), which is known to regulate cell proliferation and activation of inflammatory pathways. By inhibiting SK2, YELIVA (ABC294640) could potentially be effective in treating multiple oncology, inflammatory and gastrointestinal indications.

Reza Fathi, Ph.D., RedHill’s Senior VP Research & Development said: "The completion of the final follow-up visit by the last patient in the Phase I study of YELIVA (ABC294640) is an important milestone for RedHill, and we look forward to completing the analysis of the study, which includes analysis of plasma S1P levels as a potential new pharmacodynamic biomarker for anti-cancer activity of a sphingolipid targeted drug."

RedHill recently initiated a Phase I/II clinical study in the U.S. evaluating YELIVA (ABC294640) in patients with refractory/relapsed diffuse large B-cell lymphoma (DLBCL), primarily patients with HIV-related DLBCL, supported by a grant from the NCI Small Business Technology Transfer (STTR) program. Additional Phase II clinical studies are planned, including a multiple myeloma study to be conducted at Duke University and supported by the NCI, and a radioprotection study to evaluate potential prevention of mucositis in cancer patients undergoing therapeutic radiotherapy. Numerous successful pre-clinical studies were conducted with YELIVA (ABC294640) in GI, inflammation, radioprotection and oncology models.

The studies with YELIVA (ABC294640) are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health which provides public access to information on publicly and privately supported clinical studies.

About YELIVA (ABC294640):

YELIVA (ABC294640) is a first-in-class, proprietary sphingosine kinase-2 (SK2) selective inhibitor, administered orally, with anti-cancer and anti-inflammatory activities, targeting multiple potential oncology, inflammatory and gastrointestinal indications. By inhibiting the SK2 enzyme, YELIVA (ABC294640) blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid that promotes cancer growth and pathological inflammation. YELIVA (ABC294640) was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful pre-clinical studies in oncology, inflammation, GI, and radioprotection models, as well as the ABC-101 Phase I clinical study in cancer patients with advanced solid tumors. A Phase I/II clinical study evaluating YELIVA (ABC294640) in patients with refractory/relapsed diffuse large B-cell lymphoma (DLBCL) has been initiated in the U.S. The development of YELIVA (ABC294640) was funded to date primarily by grants and contracts from U.S. federal and state government agencies.

8-K – Current report

On August 31, 2015 Bio-Path Holdings, Inc., (NASDAQ: BPTH) (Bio-Path), a biotechnology company developing a liposomal delivery technology for nucleic acid cancer drugs, reported the formation of its inaugural Scientific Advisory Board comprised of leading oncology experts (Filing, 8-K, Bio-Path Holdings, SEP 1, 2015, View Source [SID:1234507371]). Jorge Cortes, M.D., renowned leukemia expert from The University of Texas MD Anderson Cancer Center, will join as Chairman, where he will provide clinical and scientific guidance, and work with Bio-Path to identify and attract additional oncology thought leaders to join the Company’s growing Scientific Advisory Board. Amy P. Sing, M.D., a member of Bio-Path’s board of directors and Senior Director of Medical Affairs at Genomic Health, Inc., will also join as a founding member.

"We are honored to have attracted such esteemed oncology experts to join our Scientific Advisory Board," said Peter Nielsen, President and Chief Executive Officer of Bio-Path. "The creation of this board is a testament to the level of confidence in Bio-Path’s pipeline of nucleic acid therapies and lipid-based delivery technology. Dr. Sing and Dr. Cortes’ vast expertise in oncology and the treatment of blood cancers will be invaluable as Bio-Path continues clinical development of our lead candidate, Liposomal Grb-2. We look forward to benefitting from their contributions and expanding our board in the future."

Dr. Cortes joins Bio-Path’s Scientific Advisory Board as a well-established expert in oncology and hematology. He currently holds several positions at The University of Texas MD Anderson Cancer Center, including Jane and John Justin Distinguished Chair in Leukemia Research, Chief of the AML (acute myeloid leukemia) and CML (chronic myelogenous leukemia) sections, and Deputy Chair of the Department of Leukemia.

Over the course of his 25-year career specializing in leukemia research, Dr. Cortes has held several prestigious academic appointments at the University of Texas, including associate professor in the Department of Leukemia at the Graduate School of Biomedical Sciences and Chair of the CML section at the MD Anderson Cancer Center.

Dr. Cortes has also lent his experience as a consultant to leading pharmaceutical companies such as AstraZeneca on the development of prenyltransferase inhibitors, GlaxoSmithKline on the use of topotecan in MDS (myelodysplastic syndromes) and CMML (chronic myelomonocytic leukemia), and Rhône-Poulenc Rorer on the use of PEG-Asparaginase in adult ALL (acute lymphoblastic leukemia).
Dr. Cortes earned his M.D. from la Facultad de Medicina, Universidad Nacional Autónoma de México and a B.S. from el Centro Universitario México. He currently serves on the National CML Society’s Medical Advisory Board, as well as on numerous other executive committees and scientific advisory boards for organizations such as the Leukemia & Lymphoma Society and the International CML Foundation.

"As a hematologist and clinical researcher, I have dedicated my career to improving cancer outcomes and discovering better therapies for blood cancers such as AML and CML," said Dr. Cortes. "I have the utmost confidence in Bio-Path’s executive leadership and its novel liposomal Grb-2. I look forward to helping guide the Company as it makes meaningful strides in developing and strengthening its pipeline of products using liposomal delivery technology."

Dr. Sing joins the Scientific Advisory Board as a member of Bio-Path’s board of directors, where she has served since November 2014. She is the Senior Director of Medical Affairs at Genomic Health, Inc., a global health company focused on improving the quality of cancer treatment through a genomic-based approach. Dr. Sing has more than 20 years of experience working in the oncology space in various roles. Earlier in her career, she served as Senior Medical Director at Genentech, Inc., where she played an integral role in the Avastin program. Earlier, Dr. Sing served as the Senior Director of Medical and Regulatory Affairs at Seattle Genetics, at which she managed clinical programs for the company’s various antibody drug conjugates for the treatment of cancers.

Dr. Sing earned an M.D. from the Stanford University School of Medicine, and conducted research at notable medical institutes, including the Dana Farber Cancer Institutes and Fred Hutchinson Cancer Research Center. She also holds a B.A. from Amherst College.

"Bio-Path has a unique and potentially best-in-class approach to treating cancer," said Dr. Sing. "I am honored to join the Scientific Advisory Board and am eager to lend my expertise as the Company continues its mission."

CytRx Announces Participation at FBR & Co. Second Annual Health Conference and Rodman & Renshaw 17th Annual Global Investment Conference

On September 1, 2015 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported that Steven A. Kriegsman, Chairman and Chief Executive Officer, and David Haen, Vice President of Business Development and Investor Relations, will present a corporate overview at two significant investment conferences in September, 2015 that spotlight the biotechnology and healthcare industries: the FBR & Co. Second Annual Health Conference and the Rodman & Renshaw Annual Global Investment Conference (Press release, CytRx, SEP 1, 2015, View Source;p=RssLanding&cat=news&id=2084014 [SID:1234507368]).

FBR & Co. Second Annual Health Conference
This conference will be held on Wednesday, September 9th at the Four Seasons Hotel in Boston, Massachusetts. The Conference will feature more than 60 companies in the biotech, biopharma, managed care, pharmaceutical and clinical lab sectors.

Rodman & Renshaw 17th Annual Global Investment Conference
CytRx will present its corporate overview on Thursday, September 10th at 11:40 AM in the St. Regis Hotel in New York. More than 300 companies will be participating in specialized tracks devoted to Biotechnology / Healthcare, Metals & Mining, Technology, Cleantech, and Growth.

A live and archived webcast of the presentation will be available on the Company’s website at View Source

About Soft Tissue Sarcoma

Soft tissue sarcoma is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue, and can arise anywhere in the body at any age. According to the American Cancer Society, there are approximately 50 types of soft tissue sarcomas. In 2013 more than 11,400 new cases were diagnosed in the U.S. and approximately 4,400 Americans died from this disease. In addition, approximately 40,000 new cases and 13,000 deaths in the U.S. and Europe are part of a growing underserved market.

About SCLC

An estimated 1.6 million new cases of lung cancer are diagnosed worldwide each year. In the Western world, approximately 13-15% of cases are SCLC, a deadly form of lung cancer associated with tobacco use. The five year survival rate is less than 7%, in part because an estimated 70% of patients have extensive disease at diagnosis. According to the National Cancer Institute, more than 30,000 new cases will be diagnosed in the USA in 2014. The estimated 2014 SCLC incidences for Europe and Asia are over 58,000 and 136,000, respectively.

About Glioblastoma Multiforme

Glioblastoma is the most common and most malignant primary brain tumor in adults and afflicts more than 12,000 new patients in the U.S. annually. The median survival after diagnosis is approximately 14 months, despite patients subsequently receiving surgical resection, radiotherapy and chemotherapy. Limited efficacy of chemotherapeutic agents has been attributed to several contributing factors including insufficient drug delivery to the tumor site through the blood / brain barrier.

About Aldoxorubicin

The widely used chemotherapeutic agent doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 450 mg/m2. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors concentrate albumin, thus increasing the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. This allows for greater doses (3 ½ to 4 times) of doxorubicin to be administered while reducing its toxic side effects. In studies thus far there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 2,000 mg/m2.

Varian Puts Research Tools in the Cloud to Speed Development of Next Generation Cancer Treatment Technologies

On September 1, 2015 Varian Medical Systems (NYSE: VAR) reported it has added a new cloud-based toolkit to the company’s OncoPeer interactive online forum, making development tools available for research that has the potential to lead to next generation cancer treatment technologies (Press release, InfiMed, SEP 1, 2015, View Source [SID:1234507366]).

Varian’s new Developer Cloud houses digital tools like information about TrueBeam Developer Mode, and cloud-based applications for managing Developer Mode and simulating treatments. It is part of the company’s overall objective to empower research-oriented clinical teams to accelerate the development of new treatment techniques and processes designed to improve outcomes for cancer patients.

"When Varian introduced the TrueBeam platform in 2010, we included Developer Mode, an optional non-clinical development tool for researchers to use in pioneering and prototyping new treatment techniques," said Corey Zankowski, vice president of products and strategic portfolio management. "Many important advances have been enabled by the use of this and other Varian development tools. Developer Cloud was created to aggregate these developer tools in one place so researchers can easily access what they need. Researchers can also use the OncoPeer forum to engage in discussions with other users of the research tools, to share best practices."

In a separate development, the OncoPeer online forum, first launched last March in select geographic areas, is now accessible to Varian customers worldwide. Since March, users have established discussion groups on topics like oncology analytics, knowledge-based treatment planning, treatment planning using Eclipse software, and the physics of radiotherapy. One discussion group focuses on how to use Varian’s ARIA information system to manage a medical oncology department. Other groups share information about Varian treatment delivery platforms.

"OncoPeer is a place for customers to find others who use Varian technology and learn from one another," said Sukhveer Singh, vice president, Varian Oncology Continuum Solutions. "With the addition of the Developer Cloud, OncoPeer is now a resource for the research community as well."

Varian held an online seminar about Navigating OncoPeer last May. Interested clinicians can view a replay of the webcast at this registration website. Customers can access OncoPeer at www.oncopeer.com (registration required).

ZIOPHARM Announces Cancer Research Publication of Study Demonstrating Preferential Targeting of Solid Tumor Cells by Modified CAR T Cells

On September 1, 2015 ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), a biopharmaceutical company focused on the development and commercialization of new cancer immuno-therapies, reported the publication of a preclinical study in Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), demonstrating the preferential targeting of solid tumor cells over healthy cells using engineered chimeric antigen receptor (CAR) T cells (Press release, Ziopharm, SEP 1, 2015, View Source [SID:1234507370]). The article, titled "Tuning sensitivity of CAR to EGFR density limits recognition of normal tissue while maintaining potent anti-tumor activity," is available online first at cancerres.aacrjournals.org, and was highlighted in a press release today by AACR (Free AACR Whitepaper).

Abnormally-expressed antigens on tumors, such as epidermal growth factor receptor (EGFR) on aggressive brain tumors such as glioblastoma, can be overexpressed relative to lower, basal levels on normal tissues. Taking advantage of this observation, researchers at The University of Texas MD Anderson Cancer Center tuned the binding affinity of CARs to activate T cells based on the density of EGFR expression. The approach was based on the clinical toxicity exhibited by the EGFR-specific antibodies cetuximab and nimotuzumab, which recognize overlapping epitopes and exhibit different kinetics of binding to EGFR. The lower affinity of nimotuzumab has been credited with absence of adverse events relative to cetuximab.

Researchers engineered high-affinity cetux-CAR T cells and low-affinity nimo-CAR T cells, which were tested in vitro on cancer cells with high levels of EGFR, and normal cells with low levels of EGFR. It was found that, while the cetux-CAR T cells killed both cancer and normal cells, the nimo-CAR T cells were selectively activated only in response to cancer cells.

The researchers then tested the two populations of genetically modified T cells in mice bearing human brain cancer cells expressing high levels of EGFR and found that both cetux- and nimo-CAR T cells were equally effective in inhibiting tumor growth. However, the cetux-CAR T cells caused significant toxicity to the mice, leading to death in some, whereas the infused nimo-CAR T cells were found to be safe. The researchers further tested both CAR T cells in mice bearing cells that had low levels of EGFR (to mimic normal human cells), and found that unlike cetux-CAR T cells, the nimo-CAR T cells did not impact the growth of these cells.

"Translating the remarkable effects of adoptive CAR T-cells from liquid to solid tumors can be challenging, as many solid tumor targets are found on healthy cells, creating the opportunity for toxicity," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM and an author of the publication. "By targeting the density of tumor antigens, we have demonstrated an approach for preferentially killing cancer cells over healthy cells. In this case, the weakness of the nimo-CAR affinity is its apparent strength."

ZIOPHARM is developing various immuno-oncology programs, including CAR-T, TCR and natural killer (NK) adoptive cell based therapies, in collaboration with the MD Anderson Cancer Center and its partner Intrexon Corporation (NYSE:XON).