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Novogen (NVGN) Potential First-Line Therapy For Ovarian Cancer, Edwards Lifesciences (EW) FDA Green Light For Next-Generation Heart Valve System

|Includes:EW, Novogen Limited (NVGN)

https://staticseekingalpha.a.ssl.fastly.net/uploads/2014/6/17/saupload_nvgn.jpg Novogen Limited (NASDAQ:NVGN)

Ovarian cancer is the most lethal of all the gynecologic malignancies. It is a cancer that forms in tissues of the ovary (one of a pair of female reproductive glands in which the ova, or eggs, are formed). Most ovarian cancers are either ovarian epithelial carcinomas (cancer that begins in the cells on the surface of the ovary) or malignant germ cell tumors (cancer that begins in egg cells).

The National Cancer Institute estimated that 21,980 people in the U.S. would be diagnosed with ovarian cancer in 2014 and as many as 14,270 people will die from the disease.

Researchers at Yale School of Medicine have identified a key link between stem cell factors that fuel ovarian cancer's growth and patient prognosis. First, the "cancer stem cell" idea suggests that at the heart of every tumor there is a small subset of difficult-to-identify tumor cells that fuel the growth of the bulk of the tumor. This concept predicts that ordinary therapies typically kill the bulk of tumor cells while leaving a rich environment for continued growth of the stem cell tumor population. The second concept, dubbed "seed and soil," defines a critical role for the tumor cells' "microenvironment," which is the special environment required for cancer cell growth and spread.

NVGN and CanTx Inc., its joint venture with Yale University, reported the success of proof-of-concept pre-clinical studies confirming the potency of experimental drug, Trx-1, in the treatment of primary ovarian cancer when delivered into the peritoneal cavity.

The data presented shows that Trx-1 can significantly retard the growth of highly chemo-resistant, human ovarian cancer stem cells in an animal model considered to be highly representative of the human situation.

The animal model developed at Yale involves injecting human CD44+/MyD88+ (cancer stem) cells into the peritoneal cavity of mice, where they quickly establish highly aggressive multiple tumors comprising both CD44+/MyD88+ cells and recurrent CD44-/MyD88- cells, all highly chemo-resistant. This animal model is representative of the human situation where ovarian cancer generally is confined to the abdomen and the cells are free to spread, leading to multiple tumors often involving dozens or even hundreds of individual tumors.

Based on the potency seen in animal models to date, and the potential to prevent recurrence, NVGN and CanTx believe that Intra-Peritoneal Trx-1 could be utilized as a first-line therapy for ovarian cancer.

Trx-1 is being developed for the treatment of ovarian cancer, particularly for its ability to kill chemo-resistant ovarian cancer stem cells. NVGN and CanTx plan to file an Investigational New Drug application (NYSE:IND) with the FDA in early 2015 and to start a Phase 1 study by mid-2015.

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NVGN, an Australian drug-development company, has two main drug technology platforms: super-benzopyrans and anti-tropomyosins. Super-benzopyrans compounds have been created to have a uniform cytotoxic effect against both cancer stem cell and are being developed in the first instance for the treatment of ovarian cancer, glioblastoma and prostate cancer. Anti-tropomyosins compounds target the cancer cell cytoskeleton and are being developed for the treatment of melanoma and neuroblastoma.

More about Novogen Limited (NVGN) at www.novogen.com.

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https://staticseekingalpha.a.ssl.fastly.net/uploads/2014/6/17/saupload_ew.jpg Edwards Lifesciences Corp. (NYSE:EW)

Human heart valves are remarkable structures. These tissue-paper thin membranes attached to the heart wall constantly open and close to regulate blood flow (causing the sound of a heartbeat).

The aorta is the main artery carrying blood out of the heart. When blood leaves the heart, it flows through the aortic valve, into the aorta. In aortic stenosis, the aortic valve does not open fully. This decreases blood flow from the heart.

EW reported that it has received United States Food and Drug Administration (FDA) approval for its Edwards SAPIEN XT transcatheter aortic heart valve for the treatment of high-risk and inoperable patients suffering from severe symptomatic aortic stenosis.

This next-generation, lower-profile system, which includes the 29mm valve size for patients with a large native annulus, will allow for the treatment of more patients.

The Edwards SAPIEN XT valve will be immediately available to patients at leading cardiovascular centers across the nation, along with the NovaFlex+ transfemoral delivery system that can be delivered through a low-profile 16-French expandable sheath (eSheath) and the Ascendra+ transapical and transaortic delivery systems.

The Edwards SAPIEN XT valve has been commercially available in Europe since 2010, and received regulatory and reimbursement approval in Japan in 2013.

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EW is the global leader in the science of heart valves and hemodynamic monitoring.

More about Edwards Lifesciences Corp. (EW) at www.edwards.com.

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Disclosure: The author has no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

Stocks: NVGN, EW