HAYWARD, Calif., Aug. 6 /PRNewswire-FirstCall/ -- Kosan Biosciences Incorporated (Nasdaq: KOSN) today announced that Pfizer Inc. has initiated a Phase 1 clinical trial of motilin receptor agonist PF-04548043, formerly KOS-2187, a selective and potent motilin receptor agonist being developed for the treatment of gastroesophageal reflux disease (GERD) and potentially other gastrointestinal (GI) disorders. The Phase 1 clinical trial is designed to test the safety, tolerability and pharmacokinetics of PF-04548043 in healthy subjects. In December 2006, Kosan and Pfizer established a worldwide license agreement for Kosan's motilin agonist program, including KOS-2187 and related compounds, in a transaction potentially valued at $250 million for the successful development and commercialization of PF-04548043 for one indication as well as royalties on worldwide sales.
"Kosan today has four advancing clinical programs, underscoring the increasing value of our development pipeline," said Robert G. Johnson, Jr., M.D., Ph.D., Kosan's President and Chief Executive Officer. "Consistent with Kosan's focus on oncology, we successfully out-licensed KOS-2187 and our motilin receptor agonist program to Pfizer, a company with a strong gastrointestinal capability that could best exploit its therapeutic and commercial potential. We appreciate Pfizer's commitment to the development and potential commercialization of this promising prokinetic compound and look forward to its rapid advancement through the clinic."
About PF-04548043 and Motilin Receptor Agonists
Motilin, a hormone secreted by the small intestine, stimulates gastrointestinal motility (movement). The activity of motilin is mediated through the G-protein coupled motilin receptor found on smooth muscle cells of the GI tract and elements of the enteric nervous system. The clinical observation that the macrolide antibiotic erythromycin, a motilin receptor agonist, accelerates gastric emptying in patients with diabetic gastroparesis (impaired gastric emptying) has resulted in efforts to develop non-antibiotic macrolides (motilides) as prokinetic agents. PF-04548043 is a potent, selective motilin receptor agonist that is chemically stable and orally bioavailable and lacks antibiotic activity. In preclinical studies, PF-04548043 showed an improved safety profile relative to erythromycin and accelerated gastric emptying, suggesting that it may provide symptom relief in several GI diseases.
Although the pathophysiology underlying GERD is not fully understood, it is clear that GERD is not due to acid hyper-secretion, but rather, is due to a combination of disordered upper GI tract motility, resulting in increased ingress of gastric contents into the lower esophagus, together with impairments in esophageal clearance and protection mechanisms. Increased exposure to gastric contents, coupled with reduced ability to clear the bolus, appears to precipitate reflux symptoms. Despite adequate control of intra-gastric acidity with proton pump inhibitors, a proportion of GERD patients continues to have residual symptoms. Through improvement of GI motility and increases in the rate of gastric emptying, PF-04548043 has the potential to reduce the exposure of the esophagus to acidic and weakly acidic reflux and this may improve the symptoms of GERD.
Kosan Biosciences is a biotechnology company advancing two new classes of anticancer agents through clinical development -- Hsp90 (heat shock protein 90) inhibitors and epothilones. Kosan is leveraging its proprietary discovery platform to generate a pipeline of potentially significant product candidates, primarily in the area of oncology.
Hsp90 inhibitors have a novel mechanism of action targeting multiple pathways involved in cancer cell growth and survival. Tanespimycin (KOS-953) is being tested in combination with bortezomib (Velcade(R)) in patients with multiple myeloma in a registration program called TIME. Tanespimycin is also being studied in multiple myeloma as monotherapy, in HER2-positive metastatic breast cancer in combination with Herceptin(R) (trastuzumab), and as monotherapy in metastatic melanoma. Intravenous and oral formulations of Kosan's second-generation Hsp90 inhibitor, alvespimycin (KOS-1022), are being evaluated in Phase 1 clinical trials in hematologic cancers and in HER2-positive metastatic breast cancer.
Epothilones inhibit cell division with a mechanism of action similar to taxanes, one of the most successful classes of anti-tumor agents. KOS-1584 is in Phase 1 clinical trials in patients with solid tumors. Kosan's epothilone program is partnered with Roche through a global development and commercialization agreement.
Kosan's motilin agonist compound, KOS-2187, licensed to Pfizer, is in a Phase 1 trial in gastroesophageal reflux disease (GERD).
For additional information on Kosan Biosciences, please visit the company's website at http://www.kosan.com.
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 (the "Act"). Such forward-looking statements include but are not limited to statements relating to the potential for Kosan to receive milestone payments and royalties from the license agreement with Pfizer; the further development and potential safety, efficacy and commercialization of Kosan's product candidates, including without limitation PF-04548023 and other compounds from Kosan's motilin agonist program; and development plans with respect to PF-04548023 and the timing thereof. There are a number of important factors that could cause the results of Kosan to differ materially from those indicated by these forward-looking statements, including, among others, risks related to the development of Kosan's product candidates, including the risk that studies may not demonstrate safety and efficacy sufficient to initiate clinical trials, continue clinical development, obtain the requisite regulatory approvals or to result in a marketable product; Kosan's reliance on Pfizer for the potential manufacture, development and commercialization of any compounds from Kosan's motilin agonist program, including PF-04548043; and other risks detailed from time to time in the Company's SEC reports, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2007 and other periodic filings with the SEC. Kosan does not undertake any obligation to update forward-looking statements.
Velcade(R) (bortezomib) is a registered trademark of Millennium Pharmaceuticals, Inc.
Herceptin(R) (trastuzumab) is a registered trademark of Genentech, Inc.
|SOURCE Kosan Biosciences Incorporated|
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