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]).

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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.

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.

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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."

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.

On September 1, 2015 CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company") reported that in the month of August it has enrolled 19 patients in its ongoing Phase 3 trial of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary squamous cell carcinoma of the oral cavity/soft palate, a type of head and neck cancer (Press release, Cel-Sci, SEP 1, 2015, View Source [SID:1234507373]). Total patient enrollment is now 540 as of August 31, 2015 in the world’s largest Phase 3 study in head and neck cancer.

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"A lower enrollment number in the month of August was expected since the majority of our clinical sites are in Europe and the month of August is known to be a primary vacation time in Europe. We expect enrollment in the fall to increase rapidly again with the goal of being completely enrolled by March of next year," stated CEL-SCI Chief Executive Officer Geert Kersten.

A total of 880 patients are expected to be enrolled, through approximately 100 clinical centers in over 20 countries.

About the Multikine Phase 3 Study

The Multikine Phase 3 study is enrolling just diagnosed, not yet treated patients with advanced primary squamous cell carcinoma of the head and neck. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care ("SOC") vs. subjects who are treated with SOC only. Standard of care for these patients consists of the surgical removal of the tumor and any locally involved lymph nodes, followed by radiotherapy or concurrent radiochemotherapy.

About Multikine

Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase 3 clinical trial as a potential first-line treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.

Multikine is also being tested in a Phase 1 study under a Cooperative Research and Development Agreement ("CRADA") with the U.S. Naval Medical Center, San Diego, and at University of California, San Francisco (UCSF), as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. CEL-SCI has also entered into two co-development agreements with Ergomed Clinical Research Limited to further the development of Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.

On August 31, 2015 Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, reported that final clinical data from Stage 1 of the ongoing two-stage Phase 2 study (GOG-0265) of Advaxis’s lead Lm Technology immunotherapy, axalimogene filolisbac (ADXS-HPV), in patients with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC), will be presented at the American Gynecological & Obstetrical Society (AGOS) annual meeting in Half Moon Bay, Calif. by Tom Hertzog, M.D., Clinical Director at the University of Cincinnati Cancer Institute, on September 17, 2015, at 11:15 a.m. PDT (Press release, Advaxis, AUG 31, 2015, View Source [SID:1234507360]).

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"There are limited therapies available in metastatic cervical cancer, particularly for patients who have failed at least one line of therapy," said Dr. Hertzog. "We see the potential for axalimogene filolisbac to fill a significant unmet need in the treatment of this disease and look forward to presenting these Stage 1 data at the AGOS annual meeting."

GOG-0265 is an open-label, single-arm, two-stage Phase 2 study designed to evaluate the safety, tolerability and efficacy of axalimogene filolisbac in approximately 67 patients with PRmCC who have received at least one prior line of systemic therapy. The primary efficacy endpoint is 12-month overall survival rate, with secondary efficacy endpoints of progression-free survival, overall survival and objective tumor response. The primary safety endpoints are the number of patients with dose-limiting toxicities and the frequency and severity of adverse effects.

The trial is being conducted in the United States by the Gynecologic Oncology Group (GOG), now part of NRG Oncology, under the sponsorship of the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI). Further information about the study can be found on ClinicalTrials.gov, using Identifier NCT01266460.

About Cervical Cancer

Cervical cancer is the fourth most common cancer and the most common cause of mortality in women worldwide. In the United States, nearly 13,000 new cases are diagnosed and approximately 4,100 deaths are reported because of cervical cancer. According to the WHO/ICO Information Centre on HPV and Cervical Cancer, about 3.9 percent of women in the U.S. are estimated to harbor high-risk cervical HPV infection at a given time, and 71.7 percent of invasive cervical cancers are attributed to high-risk HPV strains.

About Axalimogene Filolisbac

Axalimogene filolisbac (ADXS-HPV) is Advaxis’s lead Lm Technology immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company’s Lm Technology.