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American Cancer Society Lawn Mower Race Benefits Relay For Life. STA-BIL® Fuel Stabilizer and U.S. Lawn Mower Racing …

WALTHAM, Mass., May 16, 2012 /PRNewswire/ –Syndax Pharmaceuticals, Inc., an oncology company moving into phase 3 having completed randomized, placebo controlled phase 2 studies, announced Luke Evnin, Ph.D. will join the board of directors replacing Steven St. Peter, M.D.

“We are thankful to Steven for his commitment over the past few years and we are excited to have Luke join the board given his experience and track record of building cutting-edge biotechnology companies since 1990,” said Dennis Podlesak, chairman of the Syndax board of directors. “Syndax is well positioned to bring its lead product entinostat into phase 3 testing and to continue building out the company to support this growth phase.”

Dr. Evnin has served as a managing director at MPM Capital since he co-founded MPM’s asset management business in 1997. Dr. Evnin focuses on global healthcare investing for MPM. Prior to joining MPM, Dr. Evnin was at Accel Partners for over seven years including four as a general partner. He was involved in biopharmaceutical, medical device and healthcare service companies for several of Accel’s funds. Dr. Evnin currently serves as a director of Enteromedics, Inc. (ETRM) and Pacira (PCRX), publicly-traded companies, as well as private companies, NeuroTherapeutics Pharma, Inc. and Oxagen Limited. Dr. Evnin earned his Ph.D. in the department of biochemistry at the University of California-San Francisco, and received his A.B. in molecular biology magna cum laude from Princeton University.

“With entinostat, a promising late-stage oncology product candidate, and a talented management team in place, our vision at MPM that we invested in several years ago is now being realized,” said Dr. Evnin. “If the randomized phase 2 data is confirmed in a phase 3 trial, entinostat, an oral HDAC, will be a new and compelling option to allow women to remain successfully treated with hormone therapy, the standard of care for metastatic breast cancer. Entinostat has shown in preclinical trials the ability to reverse or delay the emergence of epigentically driven resistance to targeted therapies in solid tumors. I am looking forward to contributing to moving this promising oncology product candidate forward and building a company that can maximize its impact for patients.”

About Syndax Syndax is a late-stage oncology company initiating pivotal programs in solid tumors based on employing epigenetic strategies to overcome the problem of resistance in oncology care. Syndax holds worldwide rights to entinostat, an oral, highly selective histone deacetylase (HDAC) inhibitor, which inhibits the cancer-relevant class 1 HDAC enzymes that contribute to epigenetic alterations driving cancer growth and drug tolerance. Entinostat’s unique pharmacokinetic properties, convenient oral dosing and HDAC selectivity, maximize the opportunity to safely combine with and potentially extend the benefit of proven cancer therapies. Entinostat has been studied in more than 600 cancer patients with clinical activity in solid tumors and hematologic malignancies. Randomized, placebo-controlled phase 2 studies with entinostat have demonstrated promising results in combination with aromatase inhibitors in breast cancer (ENCORE 301) and with the EGFR-TKI erlotinib (ENCORE 401) in non-small cell lung cancer. Results from the ENCORE clinical program have provided the basis for moving entinostat into pivotal, phase 3 testing across a platform of solid tumor indications. NCI and Syndax are collaborating on the development of entinostat under a Cooperative Research and Development Agreement.

The company is supported by top venture capitalists and led by industry experts developing treatments for large markets including metastatic breast and lung cancer. Formed in 2005, Syndax’s intellectual property is based on work from scientific founder Ronald Evans, Ph.D., recipient of the 2004 Albert Lasker Prize for Basic Medical Research, a Member of the National Academy of Sciences, a professor at the Salk Institute for Biological Studies and a Howard Hughes Medical Institute Investigator. For more information please visit www.syndax.com.

Syndax Contact InformationE. Blair Schoeb Phone: 917.432.9275 Email: bschoeb@syndax.com

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Syndax Pharmaceuticals Appoints Luke Evnin, Ph.D. to Board of Directors

CAMBRIDGE, Mass. & TOKYO–(BUSINESS WIRE)–

AVEO Oncology (NASDAQ:AVEO – News) and Astellas Pharma Inc. (TSE:4503) today announced that detailed data from TIVO-1 (Tivozanib Versus Sorafenib in 1st line Advanced RCC), will be presented on June 2 in an oral session by the principal investigator, Robert J. Motzer, M.D., attending physician, genitourinary oncology service, Memorial Sloan-Kettering Cancer Center, professor of medicine, Weill Medical College, Cornell University, New York, at the 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO).

TIVO-1 is the first superiority pivotal study in first-line advanced renal cell carcinoma (RCC) in which an investigational agent (tivozanib) has demonstrated statistically significant and clinically meaningful progression-free survival (PFS) superiority versus an approved targeted agent (sorafenib) in advanced RCC.

TIVO-1 is novel in that this Phase 3 clinical study used an approved targeted comparator drug to evaluate first-line RCC treatment, said Dr. Motzer. Patients in the study who had no prior treatment for advanced kidney cancer and who were given tivozanib met the primary PFS endpoint and tolerated the drug well.

A total of 517 patients were randomized to tivozanib (N=260) or sorafenib (N=257). The performance status and other prognostic indicators of patients enrolled in this study were consistent with other pivotal trials in first-line advanced RCC.

Despite recent advances in the treatment of kidney cancer, patients are in need of new options which are effective and well-tolerated, said Daniel George, M.D., director, GU Medical Oncology and director, prostate clinic, Duke University. The superior PFS and favorable tolerability demonstrated by tivozanib in TIVO-1 represents an important potential step forward for patients in the treatment of kidney cancer.

Key data from TIVO-1 to be highlighted include (Abstract # 4501):

Overall survival (OS) data are not yet mature. In TIVO-1, 53% of patients randomized to the sorafenib arm of the trial went on to receive subsequent therapy, nearly all of whom received tivozanib after sorafenib. Based on an early, interim analysis, 81% of these patients achieved one year OS. In comparison, only 17% of patients randomized to tivozanib went on to receive a subsequent therapy, and 77% of these patients achieved one year OS. Mature data are expected to be presented in 2013.

We believe that tivozanib may play a significant role in improving the treatment of patients with advanced kidney cancer, stated Tuan Ha-Ngoc, president and CEO of AVEO Oncology. Together with our partner Astellas, we look forward to the next steps in our registration process and are continuing our preparations for the planned commercialization of tivozanib.

Based on these data, we look forward to advancing tivozanib in kidney cancer with AVEO, stated Steven Ryder, M.D., president, Astellas Pharma Global Development. These data further support Astellas goal of leadership in oncology and our commitment to developing a world-class oncology platform based on innovative, research-driven solutions and dynamic partnerships.

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AVEO and Astellas Announce Positive Findings from TIVO-1 Superiority Study of Tivozanib in First-Line Advanced RCC

WAYNE, N.J., May 16, 2012 /PRNewswire/ –Bayer HealthCare announced today that data on Nexavar (sorafenib) tablets and several of its investigational oncology compounds will be presented in a scientific forum at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO), June 1-5, in Chicago, IL. These data, including oral presentations of two Late-Breaking Abstracts on the late-stage compounds regorafenib and radium-223 chloride, reflect Bayer’s commitment to oncology research and development.

“We are pleased to present Phase III data in cancers that warrant further development.At Bayer, we are dedicated to researching new treatments for people living with cancer,” said Pamela A. Cyrus, M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals.

Notable studies evaluating Bayer’s oncology products and compounds at ASCO include:

Regorafenib

Radium-223 Chloride

BAY 86-9766

Regorafenib and radium-223 chloride are investigational agents and are not approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) or other Health Authorities.

About NexavarNexavar is approved in the U.S. for the treatment of patients with unresectable liver cancer and for the treatment of patients with advanced kidney cancer. Nexavar inhibits both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to inhibit members of two classes of kinases thought to be involved in both cell proliferation (growth) and angiogenesis (blood supply) two important processes that enable cancer growth. These kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.

Nexavar is currently approved in more than 100 countries.

Nexavar is also being evaluated by the companies, international study groups, government agencies and individual investigators.

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48th Annual Meeting of the American Society of Clinical Oncology (ASCO): Bayer to Present Data on Late-Stage Oncology …

Published on May 17, 2012 at 2:34 AM

Radiation oncology researchers have revised the system used by doctors since the 1990s to determine the prognosis of people with glioblastoma, which is the most devastating of malignant brain tumors.

The outdated system was devised for glioblastoma and related brain tumors that were treated by radiation therapy only, and it relied on clinical signs and symptoms. It divided patients into six prognostic groups. The new system accommodates advances in treatment – particularly the use of radiation therapy plus the chemotherapy drug temozolomide – and it incorporates molecular biomarkers as well as clinical variables.

“The new model is more relevant and contemporary and should do a better job of identifying patients that require the most aggressive therapy,” says the study’s chair for Translational Research Dr. Arnab Chakravarti, professor of Radiation Oncology and co-director of the brain tumor program at the Ohio State University Comprehensive Cancer Center – Arthur G. James Comprehensive Cancer Center and Richard J. Solove Research Institute (OSUCCC – James).

Chakravarti will present the findings at the 2012 annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

To devise the new system, Chakravarti and his colleagues compared tumor and healthy tissue from 162 glioblastoma patients who were treated under the Radiation Oncology Group clinical trial 0525 (RTOG 0525). The investigators profiled protein, messenger RNA and epigenetic changes in patients’ tumor cells looking for alterations in key signaling molecules.

They showed that high expression of the proteins called pAKT, c-met, and MGMT was associated with poor prognosis, while methylation of the MGMT gene, which codes for a DNA repair protein, was associated with a better prognosis.

“We hope to begin further studies to validate out classification system soon,” Chakravarti says.

Source: Ohio State University Medical Center

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Radiation oncology researchers revise glioblastoma classification system

PRINCETON, N.J.–(BUSINESS WIRE)–

Bristol-Myers Squibb Company (NYSE:BMY – News) today announced that new data on its approved and investigational oncology compounds will be featured in ten oral presentations at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from June 1-5. The data further characterize the Companys cancer immunotherapies, including YERVOY (ipilimumab) in metastatic melanoma, anti-PD-1 (BMS-936558) and elotuzumab, and support the potential role of immuno-oncology in the treatment of a range of cancers.

New data on YERVOY, a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody for the treatment of metastatic melanoma, will be presented in 27 abstracts at the meeting. Safety and efficacy data for YERVOY in 830 U.S. patients with metastatic melanoma, including 3 year survival results, from the Companys global expanded access program will be presented in an oral session on Saturday, June 2. Other important data include safety results in patients with a minimum of two-years of survival in the first-line 024 Phase 3 study in combination with DTIC, and data on YERVOY in combination with existing and investigational treatments for melanoma.

Clinical data on the investigational cancer immunotherapies anti-PD-1 and anti-PD-L1 (BMS-936559) in advanced non-small-cell lung cancer, metastatic melanoma and renal cell cancer will be featured in five oral presentations four on Saturday, June 2 and one on Monday, June 4 and in the ASCO press briefing on Friday, June 1.

With the rapidly expanding knowledge of how to harness the immune system to fight cancer, we are at the tipping point of a new era of cancer treatment, said Elliott Sigal, M.D., Ph.D., executive vice president, chief scientific officer and president, Research and Development, Bristol-Myers Squibb. Immuno-oncology is a key area of focus for Bristol-Myers Squibb and we are committed to driving advances in this important field of research to help address significant unmet medical needs in a broad range of cancers.

Additional Key Oncology Compound Data

Bristol-Myers Squibb and its partner, Abbott, will present updated Phase 2 results on the investigational cancer immunotherapy elotuzumab, which is in Phase 3 development for the treatment of multiple myeloma. Elotuzumab is a humanized monoclonal antibody specifically targeted against CS1, a cell-surface glycoprotein that is highly and uniformly expressed on multiple myeloma cells. On Monday, June 4, updated results evaluating the safety and efficacy of elotuzumab plus lenalidomide and low-dose dexamethasone in patients with relapsed multiple myeloma will be presented during an oral session. Phase 3 clinical trials for elotuzumab in previously untreated and relapsed multiple myeloma are actively recruiting patients.

Separately, the company and its partner, Otsuka Pharmaceutical Co., Ltd., will present three-year follow up data from the Phase 3 head-to-head DASISION trial, evaluating SPRYCEL (dasatinib) vs. Gleevec* (imatinib mesylate) in the treatment of patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic-phase. Long-term follow up data (6 years) from the Phase 3 study (-034) that evaluated the safety and efficacy of SPRYCEL in the treatment of Ph+ CML patients with resistance or intolerance to Gleevec will also be presented. Data from both studies will be discussed during oral sessions on Monday, June 4.

ERBITUX (cetuximab) data in abstracts that span a wide range of investigational uses in solid tumors such as colorectal and head and neck will be presented. On Monday, June 4, additional analysis from the CRYSTAL study of ERBITUX in the first-line treatment of metastatic colorectal cancer (mCRC) will be presented. CRYSTAL served as the basis for the first-line mCRC supplement biologics application for ERBITUX. The Company expects the FDA to take action on the filing in the second half of this year. Bristol-Myers Squibb is developing ERBITUX in partnership with Eli Lilly and Company.

Advancing Disease State Understanding

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New Data from Bristol-Myers Squibb Oncology Portfolio to be Presented at 2012 American Society of Clinical Oncology …

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Police: Photo of 'hit' sought

GREENWOOD, Miss. A well-known Mississippi oncologist accused of orchestrating a plot to kill his ex-wife’s divorce lawyer said he wanted a picture of the slain attorney with a “bullet between his eyes,” according to testimony Wednesday.

The lawyer was never hurt, though, in part because state agents were tipped off to the possible $20,000 murder-for-hire plot and were waiting at the attorney’s office when the hit man showed up. A shootout occurred and when the firing stopped, the alleged assassin, clad in a black ski mask, was dead and his associate was severely wounded. A bullet also grazed an attorney general’s office investigator.

Dr. Ralph Arnold Smith Jr., 70, is charged with conspiring to kill attorney Lee Abraham, who represented Smith’s ex-wife. The divorce records were sealed in 2005, but docket entries show the couple fought over money long after the divorce was granted in 1998.

At the preliminary hearing Wednesday, Greenwood police detective Jeff Byars testified that the doctor kept a hidden camera in his office. A video from the camera shows Smith telling an alleged hit man, Keaira Byrd, 23, that he wanted a photo showing Abraham dead.

“Take a picture of him with a bullet between his eyes,” Byars said, describing the video.

The men’s faces were not visible on the video, and some of it was inaudible.

Byrd was carrying a semi-automatic pistol with a 30-round clip when he walked into Abraham’s office April 28, according to Byars. It’s not yet clear if Byrd or the investigators shot first.

Byrd’s associate, Derrick Lacy, 25, was as shot several times in the back and in the leg and has been released on house arrest while he recovers. Lacy is charged with capital murder and conspiracy to commit murder.

County Judge Kevin Adams determined there was enough evidence to send the case to a grand jury. The judge ordered the doctor held without bond on the capital murder charge and on a conspiracy to commit murder charge. His bond remained $100,000 on a second conspiracy to commit murder charge.

The two conspiracy charges are both related to plots to kill Abraham, but involve different men the doctor approached to help carry out the plan, according to testimony.

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Detective: Video shows Mississippi doctor discussing plot to kill ex-wife's divorce attorney

GREENWOOD The last time the public saw Dr. Arnold Smith, the shackled physician was being yanked out of a courtroom after arguing with a judge two weeks ago.

Now the 70-year-old Greenwood oncologist, accused of conspiring to kill attorney Lee Abraham, will get his second day in court today.

Leflore County Court Judge Kevin Adams will hold a preliminary hearing at 9 a.m. Wednesday at the Leflore County Courthouse.

The purpose of a preliminary hearing is to decide whether there is probable cause to refer a person accused of a crime to a grand jury. Testimony is given, and the accused can cross-examine witnesses and offer evidence.

Smith is charged with conspiracy to commit murder for allegedly plotting to kill Abraham, whom Smith has held a grudge against for years and accused of exerting strong political and economic influence.

He’s also charged with capital murder in the death of Keaira Byrd, an alleged hired killer who died following a shootout with state attorney general’s office agents at Abraham’s Market Street office on April 28.

Smith has been held at the Leflore County Jail since being arrested before dawn on April 29. Justice Court Judge Jim Campbell denied bond on May 2 during Smith’s initial appearance.

If Smith is referred to the grand jury, Adams will review the bond.

John Colette, a Jackson defense attorney not associated with this case, said after bond was denied that it was an unusual move.

“I think that’s an awful big stretch and probably somewhat punitive,” Colette said.

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Accused oncologist has second court date

By HOLBROOK MOHR Associated Press

GREENWOOD, Miss. (AP) – A well-known Mississippi oncologist accused of orchestrating a plot to kill his ex-wife’s divorce lawyer said he wanted a picture of the slain attorney with a “bullet between his eyes,” according to testimony Wednesday.

The lawyer was never hurt, though, in part because state agents were tipped off to the possible $20,000 murder-for-hire plot and were waiting at the attorney’s office when the hit man showed up. A shootout occurred and when the firing stopped, the alleged assassin, clad in a black ski mask, was dead and his associate was severely wounded. A bullet also grazed an attorney general’s office investigator.

Dr. Ralph Arnold Smith Jr., 70, is charged with conspiring to kill attorney Lee Abraham, who represented Smith’s ex-wife. The divorce records were sealed in 2005, but docket entries show the couple fought over money long after the divorce was granted in 1998.

At the preliminary hearing Wednesday, Greenwood police detective Jeff Byars testified that the doctor kept a hidden camera in his office. A video from the camera shows Smith telling an alleged hit man, Keaira Byrd, 23, that he wanted a photo showing Abraham dead.

“Take a picture of him with a bullet between his eyes,” Byars said, describing the video.

The men’s faces were not visible on the video, and some of it was inaudible.

Byrd was carrying a semi-automatic pistol with a 30-round clip when he walked into Abraham’s office April 28, according to Byars. It’s not yet clear if Byrd or the investigators shot first.

Byrd’s associate, Derrick Lacy, 25, was as shot several times in the back and in the leg and has been released on house arrest while he recovers. Lacy is charged with capital murder and conspiracy to commit murder.

County Judge Kevin Adams determined there was enough evidence to send the case to a grand jury. The judge ordered the doctor held without bond on the capital murder charge and on a conspiracy to commit murder charge. His bond remained $100,000 on a second conspiracy to commit murder charge.

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Detective: Video shows Miss. murder-for-hire plan