By: Tomas Ronolski - AllPennyStocks.com News

Tuesday, January 21, 2014

According to the American Cancer Society, approximately 49,500 cases of endometrial cancer were diagnosed in 2013 and about 8,200 women would die from the disease. Interestingly, a study by researchers at the University of Minnesota was published in the online version of Cancer Epidemiology, Biomarker and Prevention in December that showed women who consume a large amount of sugared beverages are at a higher risk to develop Type 1, but not Type 2, endometrial cancer. Estrogen-dependent Type 1 endometrial cancer, often called uterine cancer (although there are several types of uterine cancer), is the most common form of the disease. It is most frequently diagnosed in women over the age of 55. New Jersey-based Arno Therapeutics, Inc. (OTCQB:ARNI) is developing new products for the treatment of a spectrum of cancers through a licensing agreement giving them development and marketing rights for three innovative products, onapristone, AR-42 and AR-12.

AR-42, a novel oral therapy, is in a Phase 1 clinical trial for hematological malignancies and solid tumors. The drug candidate has garnered an Orphan Drug designation from the U.S. Food and Drug Administration for treatment of meningioma and schwannoma of the central nervous system, two types of rare and benign tumors that can present in the brain and spinal cord. Arno has licensed the drug from the Ohio State University Research Foundation.

AR-12, an oral PKD-1 inhibitor also licensed from OSU, is in a Phase 1 clinical trial for adults with advanced or recurrent solid tumors or lymphoma. The trial’s protocol was originally anticipated to be a two-stage format, with the first stage evaluating safety and identifying maximum tolerated dose and the second phase targeting selected tumor types. Arno has since decided to forgo the second stage in favor of reformulating the drug with greater bioavailability, meaning that a new Phase 1 will have to be conducted.

On Tuesday, Arno announced that it has hit a new milestone with the first patient enrolled in a Phase 1 clinical trial of onapristone, a drug candidate being licensed from Invivis Pharmaceuticals. A progesterone receptor atogonist, onapristone has been through several early stage clinical trials, including studies conducted as a breast cancer drug by drug giant Schering in the days before it merged with Merck & Co. (NYSE:MRK). Additional trials showed onapristone therapy achieved a 56% objective response rate as a first-line endocrine treatment of breast cancer and a 49% clinical benefit rate in breast cancer patients previously treated with tamoxifen, a widely used chemotherapy drug first discovered by Imperial Chemical Industries before it became AstraZeneca (NYSE:AZN).

The new dose-escalating trial is evaluating onapristone in post-menopausal women with progesterone receptor (PR) positive tumors, including endometrial, breast and other solid tumors. As with other Phase 1 trials, the drug will be assessed for safety, determination of an optimal dose for mid-stage trials and for which type of cancer line the drug may be most efficacious.

The trial, which is being hosted at multiple sites in France, is designed to evaluate onapristone in sustained release and immediate release formulations in up to six dose levels. 60 patients are expected to be enrolled in the trial.

"We are focused on driving forward the development of onapristone in the most efficient and cost-effective manner and believe it could fill a unique position in the market as there is significant potential for it to be the first approved anti-progestin in oncology,” said Glenn Mattes, president and chief executive of Arno, in a statement today. He added, “We are at the forefront of establishing a genuine appreciation for the role of the progesterone receptor in cancer and the activated form as a biomarker, and we look forward to successfully developing our program.”

With any developmental biotech, it’s impressive to see diversification of potential indications to treat, especially with novel compounds. The company recapitalized late in 2013, pulling its share structure down to only 20.4 million shares outstanding (1 for 8 reverse split) while raising gross proceeds of $30.7 million to fund developments. With a market cap of $61 million and three clinical trials in play, there is significant upside potential should clinical data from these trials support mid-stage trials for these areas of great unmet medical need. Proper due diligence is, as always, encouraged.

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