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Curis Inc. - More Than Skin Deep

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Basal cell carcinoma, which is rarely fatal, is a type of skin cancer that occurs most frequently due to high sun exposure. It is estimated that about 2 million cases of basal cell carcinoma are diagnosed in the U.S. annually.

One oral candidate drug for inoperable basal cell carcinoma, which has advanced to NDA filing is Vismodegib, being developed under a deal between Roche subsidiary Genentech and Curis Inc. (CRIS).

For readers who are new to the Lexington, Massachusetts-based Curis, here's a brief overview of its pipeline and the upcoming catalysts...

The most-advanced program in Curis' pipeline is Vismodegib, an oral medicine that is designed to selectively inhibit signals in the hedgehog pathway. Abnormal activation of the hedgehog pathway sends signals that are known to play a role in tumor growth. More than 90 percent of basal cell carcinoma cases are associated with defects in the hedgehog signaling pathway.

A New Drug Application seeking marketing approval for Vismodegib to treat people with advanced basal cell carcinoma, also known as BCC, which includes metastatic and locally advanced BCC for whom surgery is inappropriate, was submitted to the FDA by Curis' collaborator Genentech on September 12, 2011.

The NDA was based on the results of a pivotal phase II trial known as ERIVANCE BCC which demonstrated that Vismodegib substantially shrank tumors or healed visible lesions, with observed response rates of 43 percent in locally advanced BCC patients and 30 percent in metastatic BCC patients.

Curis is eligible to receive an $8 million milestone payment from Roche unit Genentech upon FDA acceptance of the NDA submission of Vismodegib. The FDA is expected to notify a company of the acceptance or refusal of the NDA filing within 60 days of submission.

After the regulatory review, if Vismodegib passes the FDA muster, Curis will also be eligible to receive an additional milestone payment as well as royalties on any future sales.

In most cases, the recommended mode of treatment for basal cell carcinoma is surgery. There is no standard of care for advanced BCC. The FDA-approved topical treatment - Fluorouracil is effective only in treating superficial BCC.

Vismodegib is also being evaluated as a single-agent therapy for patients with operable nodular basal cell carcinoma in a phase II trial by Genentech. In addition, there are several additional phase I and II clinical trials of Vismodegib that are ongoing under a collaboration between Genentech and independent investigators and the National Cancer Institute.

The other investigational drugs in Curis' pipeline include,

* Debio 0932 (formerly CUDC-305), a small molecule inhibitor of Heat Shock Protein 90 that is currently in phase Ib clinical testing in patients with advanced solid tumors.

* CUDC-101 that simultaneously targets histone deacetylase, or HDAC, epidermal growth factor receptor, or EGFR, and human epidermal growth factor receptor 2, or Her2, currently in phase I development for advanced, refractory solid tumors as well as for specific tumor types, including breast, gastric, head and neck, liver and non-small cell lung cancers.

* CUDC-907 that is designed to inhibit histone deacetylases or HDACs - a class of enzymes, and PI3K (phosphatidylinositol 3-Kinase) pathway and is currently undergoing pre-IND enabling studies.

CUDC-101 and CUDC-907 are being internally developed by Curis while Debio 0932 is being developed by Debiopharm S.A., a Swiss corporation, under a license agreement signed with Curis in August 2009. Curis is eligible to receive up to an aggregate of $90 million in payments, as well as royalties on sales by Debiopharm or its sublicensees.

Other events to keep an eye on...

The company is expected to report full data from the phase I expansion trial, which is testing CUDC-101 in specific tumor types, including breast, gastric, head and neck, liver and non-small cell lung cancers, during the second half of 2011.

An investigational new drug application, or IND, is expected to be filed with the FDA to test an oral formulation of CUDC-907 in early 2012.

A quick look at the balance sheet...

Curis has incurred significant losses since inception. The company generates revenue from collaborative license and development agreements with biotechnology and pharmaceutical companies.

As of June 30, 2011, Curis had an accumulated deficit of roughly $733.94 million and cash of $32.7 million.

The company is scheduled to release its third quarter financial results on October 27th, before the market opens.

In the past one year, shares of Curis have hit a low of $1.38 and a high of $4.42. The stock closed Monday's trading at $3.68, up by 5.14% over previous day's close.

For comments and feedback contact: editorial@rttnews.com

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