Navigation Links
Kosan's Motilin Receptor Agonist, Licensed to Pfizer, Enters Phase 1 Clinical Trial in Gastroesophageal Reflux Disease
Date:8/19/2007

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.

About GERD

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.

About Kosan

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

Copyright©2007 PR Newswire.

Related medicine technology :

1. YM BioSciences Announces Preclinical Data Confirming Nimotuzumab Binds to the EGF Receptor and Potentiates Radiotherapy
2. Human Genome Sciences Reports Growing Evidence That Its TRAIL Receptor Antibodies Have Significant Potential in the Treatment of a Broad Range of Cancers
3. First Controlled Large-Scale Intervention Angiotensin Receptor Blocker (ARB) Trial in a Japanese Population, JIKEI HEART Study Demonstrates Significant Reduction in Blood Pressure and Protection of Organs with Valsartan
4. Positive Results Using Affitech-Identified Human Antibody That Blocks VEGF Binding to VEGF Receptor 2 in Preclinical Cancer Model Reported by Peregrine
5. Portola Pharmaceuticals Presents Positive Phase I Data of Its ADP Receptor Antagonist at the American College of Cardiology
6. Schering-Plough Announces Presentation of Phase II Trial Results for Novel Oral Thrombin Receptor Antagonist at the 2007 Annual Meeting of The American College of Cardiology/i2 Summit
7. Weight Management is Not Enough for Cannabinoid Type 1 (CB1) Receptor Antagonists to Become a Commercial Success
8. Tranzyme Pharma Presents Initial Phase IIa Data for its Novel Ghrelin Agonist, TZP-101, in Patients with Diabetic Gastroparesis
9. GlaxoSmithKline’s Hib-MenCY-TT Combination Vaccine Meets Phase II Study Endpoints of Immunogenicity and Safety Compared to Licensed Vaccines
10. CytRx Announces RNAi Delivery Nanoparticle Technology Exclusively Licensed to Subsidiary, RXi Pharmaceuticals, Described in Peer-Reviewed Journal
11. Mode of Action of EpiCept-Licensed Cancer Compound Profiled at AACR
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2016)... Cirujanos holandeses han puesto en marcha una ... compartir sus mejores prácticas por el mundo y tratar ... Europa, África, Asia y Estados ... combina la transmisión en vivo con mensajería instantánea y ... "Imagine un médico de Medicines sans Frontieres ...
(Date:5/24/2016)... HENDERSON, Nev. , May 24, 2016  Diana ... painfully "eats" her organs from the inside out.  This ... her completely dependent on her children and grandchildren to ... of her wheelchair, Diana,s family cannot haul the wheelchair.  ... rides in the car, and Diana is left to ...
(Date:5/24/2016)... May 24, 2016 Celsion Corporation (NASDAQ: ... company, today provided an update on its ongoing ... trial combining GEN-1, the Company,s DNA-based immunotherapy, with ... newly-diagnosed patients with advanced ovarian cancer who will ... GEN-1 is an IL-12 DNA plasmid vector formulated ...
Breaking Medicine Technology:
(Date:5/27/2016)... New York, NY (PRWEB) , ... May 27, ... ... health care world, this installment is bolstered by inspiring human interest stories, courtesy ... to the developing trends and tech within the industry, from leading advocates and ...
(Date:5/27/2016)... , ... May 27, 2016 , ... ... name in the pharmaceutical, medical and food industries. Aside from its GMP accreditation, ... (SIC), providing proof of successfully certified products, services and staff. , Validation Center ...
(Date:5/26/2016)... ... May 26, 2016 , ... W.S. Badger Co. Inc ., the maker ... 2016 When Work Works Award for its use of effective workplace strategies to increase ... Works project administered by the Families and Work Institute (FWI) and the Society for ...
(Date:5/26/2016)... ... May 26, 2016 , ... Georgia State University ... specialty academic programs. , Answering to the increasing demand for curricular specializations, the ... law, and environmental and land use law. ,  , “The demand for lawyers ...
(Date:5/26/2016)... ... May 26, 2016 , ... The Woodlands at John Knox Village , ... of care for living and healing, celebrated its grand opening, today. The Woodlands at ... Home provided by Empowered Staff. , “This is an incredibly fulfilling time for John ...
Breaking Medicine News(10 mins):