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Despite IPO plans, Syndax raises another $5 million for epigenetic breast cancer treatment

September 23, 2014

A company in the burgeoning field of epigenetics has raised about $5 million in debt financing, right on the heels of refiling for an initial public offering.

The company’s developing an epigenetic therapy for treatment-resistant cancers called entinostat. It was granted breakthrough therapy designation by the Food and Drug Administration, thanks to data from Phase IIB trials in metastatic breast cancer. It began Phase III trials in June, which are expected to be complete by mid-2017.

Despite IPO plans, Syndax raises another $5 million for epigenetic breast cancer treatment

September 22, 2014

By MedCity News, Meghana Keshavan |

A company in the burgeoning field of epigenetics has raised about $5 million in debt financing, right on the heels of refiling for an initial public offering.

The company’s developing an epigenetic therapy for treatment-resistant cancers called entinostat. It was granted breakthrough therapy designation by the Food and Drug Administration, thanks to data from Phase IIB trials in metastatic breast cancer. It began Phase III trials in June, which are expected to be complete by mid-2017

Tripathy Offers Perspective on HER2-Positive Breast Cancer

August 14, 2014

By Onc Live: Christina Izzo

The ever-evolving treatment landscape for patients with HER2-positive breast cancer leaves several questions unanswered regarding therapeutic sequences and whether an optimal standard of care exists. To provide further perspective on current paradigms, OncLive interviewed Debu Tripathy, MD, a breast cancer expert whose clinical research efforts focus on novel therapeutics, resistance, and the discovery of biomarkers.

Tripathy, a professor of medicine and the co-leader of the Women's Cancer Program at the University of Southern California Norris Comprehensive Cancer Center, serves as the primary investigator for the Systematic Therapies for HER2-positive Metastatic Brest Cancer Study (SystHERs), which hopes to provide information on treatment patterns across the United States.

Merrimack Pharmaceuticals Announces Initiation of HERMIONE, a Randomized Trial of MM-302 in Patients With Advanced HER2-Positive

August 12, 2014

By Merrimack Pharmaceuticals press release

Trial is Recruiting Patients Previously Treated With Ado-Trastuzumab Emtansine (T-DM1) and Pertuzumab

CAMBRIDGE, Mass., Aug. 11, 2014 (GLOBE NEWSWIRE) -- Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK) today announced the initiation of a global, open-label, randomized Phase 2 trial of MM-302, a HER2-targeted nanoliposomal encapsulation of doxorubicin, in combination with trastuzumab (Herceptin®) in patients with HER2-positive locally advanced or metastatic breast cancer. The trial was designed with input from the U.S. Food and Drug Administration (FDA) to support a potential accelerated approval application.

"While there have been new therapies approved in the HER2-positive setting, there is no standard of care for patients whose cancer progresses despite treatment with trastuzumab, T-DM1 and pertuzumab. In our experience to date, MM-302 has shown promising clinical activity and an acceptable safety profile in patients with metastatic breast cancer who have progressed on HER2-directed therapies. We are moving this trial forward with a goal of transforming the standard of care for this population," said Thomas Wickham, Ph.D., Vice President of Development and MM-302 Project Team Leader.

Update on Novel Drug Targets in Metastatic Breast Cancer

May 16, 2014

By Onc Live: Massimo Cristofanilli, MD, FACP

Metastatic breast cancer (MBC) is a fatal disease involving the expansion of cancerous cells from the breast to other areas of the body. Treatments for MBC are often limited to palliative care; as a result of MBC is usually fatal.

As research continues, factors such as age at diagnosis, hormone receptor (HR) status, human epidermal growth factor receptor 2 (HER2) overexpression/amplification, and site of metastases are currently used to stratify patients into groups with different prognoses and to predict response to systemic treatments.
 

The STAR treatment: South Jordan woman fighting cancer in unique ways

May 15, 2014

By Wendy Leonard, Utah Deseret News

SOUTH JORDAN — Michelle Thompson is knee-deep into stage 4 cancer, but you wouldn't know it from looking at her.

Her silver-blonde hair and sparkling blue eyes are just as bright as they were prior to the presumably devastating diagnosis in early 2013.

"I have this cancer that is supposed to mean a long, slow decline, but, all of a sudden, I'm feeling better," Thompson said. "I am reversing a no-reversible trend, and that sort of thing makes you happy."

It helps, too, that she's pushing herself to be better every day, including employing a newly FDA-approved procedure that eliminates her most hearty source of pain — tumors that dot her radiation-plagued broken spine.

Approximately 1.5 million Americans are diagnosed with cancer every year, and two-thirds will develop bone metastasis, with the spine being the most common site, according to the International Journal of Surgical Oncology. The painful spine tumors are particularly prevalent in breast cancer patients, like Thompson.

Guarded optimism on new breast cancer drug (CDK 4/6 Inhibitors and ER+ disease)

April 6, 2014

By Andrew Pollack, NY Times

SAN DIEGO — Researchers say that a new type of drug can help prevent advanced breast cancer from worsening, potentially providing an important new treatment option for women and a blockbuster product for Pfizer.

In a clinical trial, the drug cut in half the risk that cancer would worsen, or progress, researchers said here on Sunday. The median time before the disease progressed or the women died was 20.2 months for those who received the drug, compared with 10.2 months for the control group.

Ludwig researchers to give plenary talks on immunotherapy (CD47) at 2014 AACR Annual Meeting

April 6, 2014

By Ludwig Cancer Research press release

April 6, 2014, San Diego, Calif. - Ludwig researchers Irving Weissman and Jedd Wolchok will each give a talk during tomorrow’s plenary session of the AACR Annual Meeting 2014, starting at 8:45 am PT. The session, dedicated to one of the most promising and rapidly advancing areas of cancer research and therapy, is titled Targeted Immunotherapy: Mobilizing the Immune System against Cancer.

Weissman, who directs the Ludwig Center at Stanford, will speak about his team’s characterization of a cell-surface protein that is found on almost every major kind of cancer cell and their work describing its role in protecting malignant tissue. They have shown that cancer cells use this protein, CD47, to transmit a “don’t eat me” signal to patrolling immune cells known as macrophages, which would otherwise kill and ingest them to initiate a devastating immune attack on tumors.

ASCO Special Article in JCO Encourages Researchers, Industry to Achieve More Meaningful Results

March 20, 2014

By ASCO.org

ASCO is urging cancer researchers, clinical trial sponsors, and drug developers to employ clinical trial designs that aim to significantly extend the lives of people with cancer. 

In a Special Article published today in the Journal of Clinical Oncology, ASCO outlines overall survival goals for cancer clinical trials in several diseases that researchers should aim for—and patients should expect. The recommendations, developed by the ASCO Cancer Research Committee working with other experts and cancer patient advocates, provide examples of "clinically meaningful outcomes" in four types of cancer: advanced pancreatic, lung, breast, and colon cancers.

Emerging Trends in Treating Her2+ Metastatic Breast Cancer

March 8, 2014

By Onc Live: Dr. Kimberly Blackwell

Since its approval in 1998 to treat metastatic breast cancer, the anti-HER2 monoclonal antibody trastuzumab has dramatically expanded life expectancy and improved quality of life for women diagnosed with HER2-positive disease. It remains the standard-of-care, first-line treatment for metastatic breast cancer. In less than a decade, the FDA has added three new drugs to the arsenal to treat advanced HER2-positive disease, while a growing number of clinical studies are evaluating dual-agent approaches to therapy through a variety of drug combinations. - See more at: http://www.onclive.com/conference-coverage/mbcc-2014/Blackwell-Explores-Emerging-Trends-in-Treating-HER2-Metastatic-BC#sthash.bEsUvLip.dpuf

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