On July 20, 2015 Radius reported that Debasish Roychowdhury, M.D., who previously served as Seragon’s Acting Chief Medical Officer, has been elected to the company’s Board of Directors. Dr. Roychowdhury is a leader in the pharmaceutical industry with a strong background in oncology research and development, and regulatory and commercial operations, having previously served in key senior leadership roles at Sanofi, GlaxoSmithKline and Eli Lilly (Press release, Radius, JUL 20, 2015, View Source [SID:1234506529]). Debasish played a key role in the development and advancement of Seragon’s selective estrogen receptor degraders (SERDs) platform for breast cancer and other hormone-driven cancers.

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Radius Health also announced today that it has formed an Oncology Clinical Advisory Board (OCAB) comprised initially of two renowned leaders in the field of oncology: Professor Mitch Dowsett, FMedSci, PhD, and Professor George W. Sledge Jr.

"We are delighted to have attracted someone with Debasish’s experience and leadership in the field of oncology to join our Board of Directors. In addition, we are honored to have the esteemed counsel of two of the leading authorities in the field of breast cancer research, Professor Dowsett and Professor Sledge, join our newly formed OCAB," said Radius Health CEO, Robert E. Ward. "We are excited about the value these accomplished individuals are expected to bring to Radius as we seek to accelerate the development of RAD1901 in breast cancer."

Debasish has a distinguished track record in the field of oncology having been involved in the approval of nine oncology drugs, including Almita, Tykerb and Jevtana. Currently, he is President of Nirvan Consultants, LLC and in this capacity he serves in senior advisory roles for biotechnology companies to help advance their pipeline of therapeutics. Debasish also serves as a member of the Board of Directors for Lytix Biopharma AS.

Prior to the acquisition of Seragon by Roche, Debasish was one of the founding members of the Seragon Clinical and Scientific Advisory Board and served as Seragon’s Acting Chief Medical Officer. Previously, Debasish was the Senior Vice President of Global Oncology and Head of the Global Oncology Division at Sanofi until November 2013. Prior to that, he served as the Vice President for Clinical Development at GlaxoSmithKline and directed the oncology global regulatory group at Eli Lilly and Company. In his academic career, Debasish served as a faculty member at the University of Cincinnati. He trained at the All India Institute of Medical Sciences and University of California, San Francisco.

Oncology Clinical Advisory Board (OCAB)

Radius is pleased to announce the formation of the OCAB with its first two members, both of whom are world renowned scientific and clinical authorities in the field of oncology: Professor Mitch Dowsett, and Professor George Sledge.

Professor Mitch Dowsett, FMedSci, PhD, is Head of the Academic Department of Biochemistry and Head of the Centre for Molecular Pathology at the Royal Marsden Hospital in London, UK. He is also Professor of Biochemical Endocrinology at the Institute of Cancer Research, Professor of Translational Research in the Breakthrough Breast Cancer Centre, Team Leader for Breast Cancer Research for the Biomedical Research Centre for Cancer and Leader of the Endocrinology Team at the Breakthrough Breast Cancer Centre. Dr. Dowsett’s main scientific interests have been related to the endocrine basis of the majority of breast cancers, and his studies to understand the mechanisms of response and resistance to estrogen deprivation in the treatment of breast cancer. His studies led to the development of aromatase inhibitors.

Dr. Sledge is Professor and Chief of Medical Oncology at Stanford University Medical Center, and specializes in the study and treatment of breast cancer. Dr. Sledge directed the first large, nationwide study on the use of paclitaxel to treat advanced breast cancer. His recent research focuses on novel biologic treatments for breast cancer. He has published over 300 articles in medical journals about breast cancer and chaired several clinical trials involving new breast cancer treatments. Dr. Sledge serves as Editor-in-Chief of the journal Clinical Breast Cancer and is past President of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). He served as Chairman of the Breast Committee of the Eastern Cooperative Oncology Group from 2002 to 2009 where he played an important role in the development of several nationwide clinical trials. He has also served as Chair of ASCO (Free ASCO Whitepaper)’s Education Committee, member of the Department of Defense Breast Cancer Research Program’s Integration Panel, member of the Food and Drug Administration’s Oncology Drug Advisory Committee (ODAC) and is currently a member of the External Advisory Committee for the Cancer Genome Atlas (TCGA) project.

About the Investigational Drug RAD1901

Radius is developing the investigational drug RAD1901 as a potential treatment for estrogen-receptor-positive (ER+) breast cancer. The drug also has potential as a treatment for other ER+ cancers, such as ovarian or endometrial cancer. The National Cancer Institute estimates that approximately 70% of breast cancers are ER+ and may grow in response to exposure to estrogen. Endocrine therapy is intended to block the estrogen signal or reduce the production of estrogen. More information about breast cancer and endocrine therapy may be found on the National Cancer Institute website View Source

RAD1901 is an investigational, non-steroidal small molecule that is designed to selectively bind and degrade the estrogen receptor. RAD1901 has demonstrated potent anti-tumor activity in xenograft models of ER+ breast cancer in preclinical testing and complete suppression of the FES-PET signal after six days of dosing in a maximum tolerated dose clinical study. In preclinical models thus far, RAD1901 has shown good tissue selectivity, does not appear to stimulate the uterine endometrium, and appears to protect against bone loss in an ovariectomy-induced osteopenia rat model. In addition, we believe that RAD1901 also has the ability to cross the blood-brain barrier. Radius recently reported preclinical activity of RAD1901 in combination with either mTOR or CDK inhibitors, the results demonstrated potent tumor shrinkage in a patient-derived tumor explant animal model.

Radius has begun a Phase 1 multicenter, open-label, two-part, dose-escalation study of the investigational drug RAD1901 in postmenopausal women with advanced estrogen receptor positive and HER2-negative breast cancer. The study is designed to determine the recommended Phase 2 dose of RAD1901, and includes a preliminary evaluation of the potential anti-tumor effects. The incidence of dose limiting toxicities will be assessed during the first 28 days. Tumor response will be evaluated in patients with measurable or evaluable disease, using RECISTv1.1 guidelines every 8 weeks until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months of treatment. Plasma concentrations of RAD1901 will be assessed every 28 days for up to 12 months of treatment. The details of the Phase 1 study of RAD1901 are posted on www.clinicaltrials.gov.

Radius is also developing RAD1901 at lower doses as a Selective Estrogen Receptor Modulator for the potential treatment of vasomotor symptoms. Historically, hormone replacement therapy ("HRT") with estrogen or progesterone was considered the most efficacious approach to relieving menopausal symptoms such as hot flashes. However, because of the concerns about the potential long‑term risks and contraindications associated with HRT, Radius believes a significant need exists for new therapeutic treatment options to treat vasomotor symptoms. In a Phase 2 proof of concept study, RAD1901 at lower doses demonstrated a reduction in the frequency and severity of moderate and severe hot flashes. Radius intends to commence a Phase 2b trial in vasomotor symptoms in the second half of 2015.

On July 20, 2015 CEL-SCI reported that it has added a second clinical site for its Phase I clinical trial evaluating peri-anal wart immunotherapy in HIV/HPV co-infected men and women with its investigational cancer immunotherapy Multikine* (Leukocyte Interleukin, Injection) (Press release, Cel-Sci, JUL 20, 2015, View Source [SID:1234506530]). Dr. Joel Palefsky, world renowned scientist and Key Opinion Leader (KOL) in human papilloma virus (HPV) research and the prevention of anal cancer, has joined the study as a Principal Investigator at the University of California San Francisco (UCSF). UCSF becomes the second clinical site for the study. The first site, the U.S. Naval Medical Center San Diego, continues to enroll patients under a Cooperative Research and Development Agreement (CRADA).

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Dr. Joel Palefsky is the Chair of the HPV Working Group of the AIDS Malignancy Consortium (AMC) and is the head of the AMC HPV Virology Core Lab at UCSF. The AMC is a U.S. National Cancer Institute-supported clinical trials group founded in 1995 to support innovative trials for AIDS-related cancers. The AMC is composed of over 37 clinical trials sites worldwide, five Working Groups, an Administrative Office, a Statistical Office, and an Operations and Data Management Office. Collectively, these components develop and oversee the scientific agenda, manage the groups’ portfolio of clinical trials and other scientific-based studies, and help to develop new protocols. Dr. Palefsky has extensive experience in the biology of HPV infection, HPV infection in HIV-positive men and women, HPV vaccines and in the design and implementation of multiple clinical research trials of HPV-related disease.

Having published over 280 papers, Dr. Palefsky is Principal Investigator of the ANCHOR study, an $89 million NIH-funded study of the efficacy of secondary prevention of anal cancer. He is also the Principal Investigator on several laboratory-based and clinical research studies of HPV-associated neoplasia, particularly in the setting of HIV infection. He also specializes in the molecular biology and development of new treatments for HPV. Dr. Palefsky is the founder and immediate past president of the International Anal Neoplasia Society and is currently president of the International Human Papillomavirus Society. He is actively involved in training students in clinical and translational research. Dr. Palefsky has led the Doris Duke Charitable Foundation (DDCF) program at UCSF since its inception in 2001 and has been the leader of the Clinical Translational Science Awards (CTSA) TL1 program at UCSF since its inception in 2006.

"We are very pleased to welcome Dr. Palefsky as a Principal Investigator for our Phase I study and we believe his interest in Multikine is a very important testament of our immunotherapy’s potential in the treatment of HPV related diseases in HIV infected patients," stated CEL-SCI Chief Executive Officer Geert Kersten. "Dr. Palefsky is widely recognized as one of the world’s top researchers in the field HPV infection in HIV co-infected patients. With his participation through UCSF we anticipate rapid patient enrollment in our Phase I study."

Anal and genital warts are commonly associated with HPV, the most common sexually transmitted disease. The U.S. Center for Disease Control and Prevention (CDC) has named HPV the 4th largest health threat the U.S. will face in 2014. According to the CDC, 360,000 people in the U.S. get genital warts each year. Persistent HPV infection in the anal region is thought to be responsible for up to 80% of anal cancers. HPV is an even more significant health problem in the HIV infected population as individuals are living longer as a result of greatly improved HIV medications, but have difficulty clearing HPV due to their compromised immune system.

About Multikine for HIV/HPV Co-infected Patients

Multikine is being given to HIV/HPV co-infected patients with peri-anal warts based on the results obtained in a Multikine Phase I study conducted at the University of Maryland in which the investigational immunotherapy Multikine was given to HIV/HPV co-infected women with cervical dysplasia. In these patients, visual and histological evidence of clearance of lesions was observed. Elimination of a number of HPV strains was also determined by in situ polymerase chain reaction (PCR) performed on tissue biopsy collected before and after Multikine treatment. The study investigators reported that the study volunteers in this study all appeared to tolerate the Multikine treatment with no reported serious adverse events. The treatment regimen utilized in the Multikine cervical study in HIV/HPV co-infected patient volunteers is identical to the regimen being administered in the current Phase I study of HIV/HPV co-infected patient volunteers with peri-anal warts that is in progress at the U.S. Naval Medical Center San Diego and the University of California San Francisco.

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, 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 July 20, 2015 Heron Therapeutics, Inc. (NASDAQ:HRTX), a biotechnology company focused on improving the lives of patients by developing best-in-class medicines that address major unmet medical needs,reported that it has resubmitted its New Drug Application (NDA) for SUSTOL (granisetron) Injection, extended release, for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC) regimens, to the U.S. Food and Drug Administration (FDA) (Press release, Heron Therapeutics, JUL 20, 2015, View Source;p=RssLanding&cat=news&id=2068986 [SID:1234506539]).

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Heron expects confirmation of acceptance from the FDA and a Prescription Drug User Fee Act (PDUFA) goal date within the next few weeks. The Company anticipates a six-month review by the FDA.

The NDA filing includes data from the MAGIC study, Heron’s recently completed, multi-center, placebo-controlled, Phase 3 study in patients receiving HEC agents. The MAGIC study evaluated the efficacy and safety of SUSTOL as part of a three-drug regimen with the intravenous (IV) neurokinin-1 (NK1) receptor antagonist fosaprepitant and the IV/oral corticosteroid dexamethasone for the prevention of delayed nausea and vomiting in patients receiving HEC. The MAGIC study, which was conducted entirely in the U.S. using the 2011 ASCO (Free ASCO Whitepaper) guidelines for classification of emetogenic potential, is the only Phase 3 CINV study to-date to use the currently recommended, standard-of-care, three-drug regimen for CINV prophylaxis in a HEC population as the comparator: a 5-HT3 receptor antagonist, fosaprepitant and dexamethasone.

The MAGIC study’s primary endpoint was achieved. Specifically, the percentage of patients who achieved a Complete Response was significantly higher in the SUSTOL arm compared with the comparator arm (p=0.014). Significant benefit was also observed in the reduction in episodes of nausea, which has the greatest impact on patient quality of life. Data from a previous Phase 3 study of more than 1,300 patients, which was previously submitted to the FDA, demonstrated SUSTOL’s efficacy in the prevention of acute and delayed CINV associated with MEC regimens and acute CINV associated with HEC regimens.

"The rapid resubmission of the NDA for SUSTOL, the first and only 5-HT3 receptor antagonist with extended-release technology and 5-day CINV prevention in both MEC and HEC, is a major milestone for Heron Therapeutics," commented Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. "We look forward to working closely with the FDA during the SUSTOL NDA review period, as we believe SUSTOL has the potential to improve the lives of patients suffering from CINV by significantly reducing both nausea and vomiting associated with MEC or HEC regimens."

About SUSTOL for Chemotherapy-Induced Nausea and Vomiting

SUSTOL (granisetron) Injection, extended release, which utilizes Heron’s proprietary Biochronomer drug delivery technology, is Heron’s novel, long-acting formulation of granisetron for the prevention of chemotherapy-induced nausea and vomiting (CINV). Granisetron, an FDA-approved 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist was selected due to its broad use by physicians based on a well-established record of safety and efficacy. SUSTOL has been shown to maintain therapeutic drug levels of granisetron for five days with a single subcutaneous injection. SUSTOL is being developed for the prevention of both acute (day 1 following the administration of chemotherapy agents) and delayed (days 2-5 following the administration of chemotherapy agents) CINV associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC). While other 5-HT3 antagonists are approved for the prevention of CINV, SUSTOL is the first agent in the class to demonstrate efficacy in reducing the incidence of delayed CINV in patients receiving HEC, a major unmet medical need, in a randomized Phase 3 study.

Affecting 70-80% of patients undergoing chemotherapy, CINV is one of the most debilitating side effects of such treatments, often attributed as a leading cause of premature discontinuation of cancer treatment. 5-HT3 receptor antagonists have been shown to be among the most effective and preferred treatments for CINV. However, an unmet medical need exists for patients suffering from CINV during the delayed phase, which occurs on days 2-5 following the administration of chemotherapy agents. Only one 5-HT3 receptor antagonist is approved for the prevention of delayed CINV associated with MEC, and no 5-HT3 receptor antagonists are approved for prevention of delayed CINV associated with HEC.

SUSTOL was the subject of a recently completed, multi-center, placebo-controlled, Phase 3 clinical study in patients receiving HEC regimens known as MAGIC. The MAGIC study evaluated the efficacy and safety of SUSTOL as part of a three-drug regimen with the intravenous (IV) neurokinin-1 (NK1) receptor antagonist fosaprepitant and the IV/oral corticosteroid dexamethasone. The MAGIC study, which was conducted entirely in the U.S. using the 2011 ASCO (Free ASCO Whitepaper) guidelines for classification of emetogenic potential, is the only Phase 3 CINV prophylaxis study in a HEC population performed to date to use the currently recommended, standard-of-care, three-drug regimen as a comparator: a 5-HT3 receptor antagonist, fosaprepitant, and dexamethasone. The study’s primary endpoint was achieved. Specifically, the percentage of patients who achieved a Complete Response in the delayed phase was significantly higher in the SUSTOL arm compared with the comparator arm (p=0.014). Heron resubmitted its New Drug Application (NDA) for SUSTOL to the U.S. Food and Drug Administration (FDA) in July 2015. SUSTOL is not approved by the FDA or any other regulatory authority.

On July 20, 2015 Dr. Jack Kavanaugh, Chairman of Novonco Pharmaceuticals, Inc., reported that Novonco has licensed the exclusive rights to City of Hope’s novel anti-cancer agent COH29, a potential breakthrough agent in the fight against hard-to-treat cancers, including ovarian cancer (Press release, Novonco Therapeutics, JUL 20, 2015, View Source [SID1234645698]).

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The small molecule COH29 inhibits the production of ribonucleotide reductase (RNR), an enzyme that is central to production of many types of cancer cells. Current clinically-established RNR inhibitors — such as hydroxyurea and gemcitabine — have drawbacks, including a short half-life and drug resistance. But COH29 represents a new class of RNR inhibitors, with unique targeted-action mechanisms that limit damage to non-cancer cells, thus limiting side effects. Preclinical trials suggest it can overcome hydroxyurea and gemcitabine resistance in cancer cells and may serve as a first- or second-line treatment in relevant cancers. This novel therapeutic agent has been in development at City of Hope’s Beckman Research Institute.

In preclinical studies, COH29 has been shown to reduce tumor growth in human cancers, including leukemia and ovarian cancer — diseases that are hard to treat, and it has also shown promise against breast cancer cells. "One of the real potentials of COH29," says Dr. David Horne, co-chairman of Novonco’s Medical Advisory Board, "is its potent antitumor activity against BRCA1-deficient ovarian cancer."

Ovarian cancer (OC) is the most lethal — and the second most-common — gynecologic cancer in the United States, with over 20,000 new cases and 14,000 deaths expected yearly. Most of the cases are diagnosed at an advanced stage, with a corresponding 5-year survival rate of only 27 percent. Today, primary treatment of OC typically consists of surgery followed by first-line chemotherapy with a platinum/taxol combination. First-in-human Phase I clinical trials of COH29 are scheduled to begin in the fall of 2015 at City of Hope.

"We at Novonco are excited to work with City of Hope on COH29, which holds so much promise for the treatment of ovarian and other hard-to-treat cancers," says Dr. Kavanaugh. The company is working on two other cancer therapeutic platforms, based on individual licensing arrangements with City of Hope and the University of California Irvine.

In 2009, in conjunction with City of Hope, Dr. Kavanaugh founded ZetaRx Therapeutics. Dr. Kavanaugh was also the Chairman and CEO of ZetaRx, which became the core of Juno Therapeutics. Juno was the largest biotech IPO of 2014 and attained a market cap of approximately $6 billion.

On July 20, 2015 DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on developing and commercializing proven cancer therapies in new orphan drug indications, reported that the Sarah Cannon Cancer Research Center at HealthOne, Denver, CO has been added as a clinical trial site for the ongoing, multicenter Phase I/II study of VAL-083 in patients with refractory glioblastoma multiforme (GBM), the most common and deadly form of human brain cancer (Press release, DelMar Pharmaceuticals, JUL 20, 2015, View Source [SID:1234506538]).

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"This fifth clinical site greatly adds to our recruitment bandwidth as part of our strategy to increase patient access as we continue with the expansion phase of our Phase I/II GBM clinical trial. Our goal is to complete the expansion phase and advance VAL-083 into registration-directed Phase II/III clinical trials for refractory glioblastoma in the timeliest manner possible," said Jeffrey Bacha, president & CEO of DelMar Pharmaceuticals.

Sarah Cannon Research Institute (SCRI) is the research arm of HCA’s global cancer enterprise, Sarah Cannon. SCRI’s Denver site is directed by Gerald Falchook, M.D., M.S. Dr. Falchook completed his oncology training at MD Anderson Cancer Center, where he also served as a faculty member for six years developing investigator-initiated clinical trials as well as collaborating with pharma/biotech industry partners to bring promising new drugs to cancer patients.

"Expanding our collaboration with SCRI provides access to leading oncologists to support the development of VAL-083 as a novel cancer chemotherapy and will enable more rapid patient enrollment to our GBM clinical trial by accessing SCRI’s large network of patients," added Mr. Bacha.

DelMar’s multicenter Phase I/II study with VAL-083 is ongoing in patients with recurrent GBM. The clinical trial is an open-label, single arm, safety and tolerability dose-escalation study utilizing a standard dose escalation design, until the maximum tolerated dose (MTD) or the maximum specified dose has been reached. Eligible GBM inclusion criteria requires previous treatment with surgery and/or radiation, if appropriate. Eligible GBM patients must have failed both Avastin (bevacizumab) and Temodar (temozolomide) unless either of these therapies was contraindicated. (ClinicalTrials.gov Identifier NCT01478178).

Recently DelMar presented interim data from this ongoing study in GBM at the American Association of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual meeting. The Company confirmed the completion of the Phase I dose-escalation portion of the trial and presented data supporting a dose response trend: Patients receiving a dose ≥30mg/m2 had a median survival of 9.0 months vs. 4.4 months at doses <10mg/m2. DelMar also confirmed the initiation of a 14-patient Phase II expansion cohort at a dose of 40mg/m2. The purpose of the Phase II expansion cohort is to gain additional information about the safety and efficacy of VAL-083 at the 40mg/m2 dose prior to advancement into registration-directed Phase II/III clinical trials.

DelMar is also enrolling patients in the trial at four other oncology centers of excellence: The Mayo Clinic Cancer Center in Rochester, MN, The Brain Tumor Center at University of California, San Francisco (UCSF),.; The Sarah Cannon Cancer Research Center in Nashville, TN.; The Sarah Cannon Research Institute affiliate site at the Florida Cancer Specialist Research Institute in Sarasota, FL.; and. More information on the VAL-083 Phase I/II clinical trial in GBM may be found at View Source

About VAL-083
VAL-083 is a "first-in-class", small-molecule chemotherapeutic. In more than 40 Phase 1 and 2 clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated safety and efficacy in treating a number of cancers including lung, brain, cervical, ovarian tumors and leukemia. VAL-083 is approved in China for the treatment of chronic myelogenous leukemia and lung cancer and has received orphan drug designation in Europe and the U.S. for the treatment of gliomas.

DelMar is currently studying VAL-083 in a multi-center Phase I/II clinical trial for patients with refractory glioblastoma multiforme (GBM) in accordance with the protocol that has been filed with the U.S. Food and Drug Administration (FDA). As a potential treatment for glioblastoma, VAL-083’s mechanism of action appears to be unaffected by the expression of MGMT, a DNA repair enzyme that causes chemotherapy resistance to front-line treatment with Temodar (temozolomide).