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Celek Pharmaceuticals to Present Recent Progress on its Anticancer Drug Candidate, CEL-031, at National Cancer Institute Investor Forum

ROCKVILLE, Md.--(BUSINESS WIRE)--Apr 18, 2012 - Celek Pharmaceuticals announced that it will present an update on its anticancer drug development programs today at the National Cancer Institute (NCI)'s 2012 Investor Forum in Santa Clara, CA. The NCI selected Celek as one of 18 companies from more than 100 applicants to present at this conference. Only companies funded under the NCI's Small Business Innovation Research (SBIR) program were eligible to apply.

Celek's lead drug candidate, CEL-031, is a small molecule compound in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and acute myeloid leukemia (AML). Targeting phosphodiesterase enzymes, which are overexpressed in human tumor cells, CEL-031 activates key cell signaling pathways that result in the selective killing, or apoptosis, of cancer cells. CEL-031 showed evidence of efficacy and a favorable safety profile in earlier clinical studies as an oral treatment for several advanced cancers. At the conference, Celek will present data showing that CEL-031 is likely to have even greater clinical efficacy in NMIBC and AML based on (i) the compound's mechanism of action, and (ii) Celek's ability to achieve therapeutically effective drug concentrations using routes of delivery appropriate for these disease indications. Celek's goal is to demonstrate CEL-031's efficacy in proof-of-concept clinical trials, then partner for later stage development and commercialization of CEL-031.

Dr. Graham Allaway, Celek's CEO, commented: “We were very pleased to be chosen to present at this prestigious forum, where we will discuss our recent progress in the development of CEL-031, Celek's lead anticancer drug candidate. This product has significant potential as a new treatment for bladder cancer and AML, diseases with major unmet needs for new therapies”.

The NCI forum website states: “NCI SBIR has selected 18 SBIR-funded companies that represent the strongest, most promising innovators developing the next generation of cancer therapeutics, diagnostics, and devices primed for commercialization to present at the 2012 Investor Forum. The presenting companies were selected based on the strength of their technology and commercialization potential by a competitive process and review panel comprised of life science investment and business development experts from companies such as Merck, Pfizer, Varian, Mohr Davidow Ventures, and Fidelity Biosciences.”

About Bladder Cancer:

Bladder cancer is the 5th most common cancer in the U.S., with over 70,000 new diagnoses and 14,000 deaths in 2010. The majority (70%) of bladder cancer cases are diagnosed at the non-muscle invasive stage. Current treatments for non-muscle invasive bladder cancer (NMIBC) involve surgical removal of the tumors via cystoscopy, usually followed by treatment with BCG immunotherapy or chemotherapy with mitomycin C. However, BCG and mitomycin C often cause significant side-effects, which limit their frequency of dosing. Furthermore, these therapies often fail, with tumors recurring in approximately 70% of patients. The need for regular monitoring and treatment of NMIBC makes bladder cancer the most expensive cancer to treat on a lifetime basis.

CEL-031 would be the first targeted drug for NMIBC, designed to substantially reduce rates of tumor recurrence and progression. In this indication, CEL-031 will be instilled directly into the bladder by catheter, the standard route for delivering drugs to treat NMIBC. Celek and its collaborators, Drs. Seth Lerner and Jonathan Levitt in the Scott Department of Urology at Baylor College of Medicine, recently found that CEL-031 had potent antitumor activity in an animal model of NMIBC. This work was funded, in part, by an NCI Phase I SBIR contract to Celek.

About Acute Myeloid Leukemia (AML):

AML is the most common form of acute leukemia, with an incidence of 12,000 cases per year and a death rate of 9,000 per year in the US. About 50,000 individuals in the US are living with the disease. For most AML subtypes, the current treatment regimen, developed 40 years ago, is a combination of cytosine arabinoside (ara-C) with an anthracycline. Overall 5 year survival on this regimen is 40-50% for adults and 50-60% for children. While bone marrow stem cell transplantation can cure some patients, there is a major unmet need for new treatments for AML. A recent study by an independent group reported that CEL-031 has pro-apoptotic activity against primary bone marrow-derived cells from AML patients, including those resistant to conventional chemotherapy and those with specific mutations that are associated with a poor disease prognosis. Celek plans to initially administer CEL-031 intravenously for the treatment of AML.


Contact: Celek Pharmaceuticals
Graham Allaway, 301-461-7934


Posted: April 2012