Navigation Links
Pharmacyclics Announces Completion of Phase 1 Clinical Trial of Factor VIIa Inhibitor PCI-27483
Date:11/25/2008

SUNNYVALE, Calif., Nov. 25 /PRNewswire-FirstCall/ -- Pharmacyclics, Inc. (Nasdaq: PCYC) today announced that the company has completed a Phase 1 clinical trial with PCI-27483, the company's novel, first-in-class small-molecule Factor VIIa inhibitor. The trial was conducted in sixteen (16) healthy volunteers to evaluate the safety and pharmacologic effect of PCI-27483. A single administration of PCI-27483 resulted in a linear dose response in the International Normalized Ratio (INR), a routine laboratory test used to assess the level of anticoagulation (blood-thinning).

"Single doses of PCI-27483 reliably and quickly achieved therapeutic levels of anticoagulation without adverse effects in this initial trial," said James Lowder, M.D., Vice President, Clinical Development for Pharmacyclics. "The ability to achieve precise levels of anticoagulation that can be readily measured differentiates PCI-27483 from other available anticoagulants. The Factor VIIa: tissue factor complex, the pharmacologic target of PCI-27483, has been implicated both in the progression of solid tumors and the increased incidence of venous thromboembolic events observed in many malignancies. Up-regulation of tissue factor expression is observed in pancreatic, lung, and breast cancer, and is associated with a worsened prognosis."

In the recently completed study, PCI-27483 increased the INR with minimal intra-subject variation and a half-life of ten hours. At the highest subcutaneous dose of PCI-27483 evaluated, a mean (+/-standard error) peak INR of 2.72 (+/- 0.24) was achieved one to two hours post-dosing. The trial further established doses of PCI-27483, which upon repeated dosing are expected to maintain the INR in the range of 2.0 to 3.0, the target window for treatment and prevention of thromboembolic events (i.e., formation of blood clots).

Earlier this year, Pharmacyclics presented data at the 2008 Annual Meeting of the American Association for Cancer Research (AACR) demonstrating that PCI-27483 inhibits tumor growth in an animal model of pancreatic cancer. In previous animal studies, the company has shown that PCI-27483 inhibits the growth of human colorectal tumor cells and murine lung carcinoma cells.

"PCI-27483 is expected to have a dual effect of inhibiting tumor growth and decreasing the incidence of venous thromboembolic events in patients with cancer. We're diligently working to move PCI-27483 through clinical development, as evidenced by our early completion of the Phase 1 trial. We believe that this compound has unique potential for cancer patients," said David Loury, Ph.D., Vice President of Development for Pharmacyclics. "Recent clinical studies have shown that approximately 90% of pancreatic cancers express tissue factor. Accordingly, we are currently preparing for a Phase 1b/2 trial to begin in calendar Q2 '09 to evaluate PCI-27483's effects in patients with pancreatic cancer."

About Factor VII and PCI-27483

Factor VII is a blood protein involved in clotting. Many types of cancer, such as lung, breast, pancreatic, colorectal, gastric and others, express high levels of a cell surface protein known as tissue factor (TF). After binding to TF, Factor VII becomes activated and triggers a host of pathologic processes in the tumor microenvironment that facilitate the growth, invasion and spread of many cancers. Activation of Factor VII (Factor VIIa) by TF also leads to the high incidence of thromboembolic complications seen in cancer patients. PCI-27483 is a novel first-in-class small molecule inhibitor, which selectively targets the Factor VIIa:TF complex. PCI-27483 was developed in a large medicinal chemistry discovery and optimization program, applying high-resolution X-ray structure-based design to the development of candidates of high potency and selectivity for the Factor VIIa:TF complex.

About Pharmacyclics

Pharmacyclics(R) is committed to creating and developing novel pharmaceutical products that treat serious unmet medical needs in oncology and autoimmune diseases. Its deep and broad pipeline includes four innovative drug candidates that are currently under clinical development. The Company is headquartered in Sunnyvale, California and is listed on Nasdaq under the symbol PCYC. To learn more about how Pharmacyclics advances science to improve human healthcare visit us at http://www.pharmacyclics.com. Pharmacyclics(R) and the "pentadentate" logo(R) are registered trademarks of Pharmacyclics, Inc.

NOTE: Other than statements of historical fact, the statements made in this press release about future plans for and the timing of initiation of our clinical trials, progress of and reports of results from preclinical and clinical studies, expected effect of our products under development, clinical development plans and product development and corporate partnering activities are forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995. The words "project," "believe," "will," "may," "continue," "plan," "expect," "intend," "anticipate," variations of such words, and similar expressions also identify forward-looking statements, but their absence does not mean that the statement is not forward-looking. The forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those in the forward-looking statements. Factors that could affect actual results include risks associated with unexpected delays in clinical trials and preclinical studies and the timing for making related regulatory filings; the fact that data from preclinical studies and Phase 1 or Phase 2 clinical trials may not necessarily be indicative of future clinical trial results; our ability to estimate accurately the amount of cash to be used to fund operations over the next 12 months, our ability to obtain future financing and fund the product development of our pipeline; the initiation, timing, design, enrollment and cost of clinical trials and preclinical studies; our ability to establish successful partnerships and collaborations with third parties; the regulatory approval process in the United States and other countries; and our future capital requirements. For further information about these risks and other factors that may affect the actual results achieved by Pharmacyclics, please see the company's reports as filed with the U.S. Securities and Exchange Commission from time to time, including but not limited to its annual report on Form 10-K for the period ended June 30, 2008 and its subsequently filed quarterly reports on Form 10-Q. Forward-looking statements contained in this announcement are made as of this date, and we undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.


'/>"/>
SOURCE Pharmacyclics, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Pharmacyclics Announces Data and Publication Characterizing Highly-Selective HDAC Inhibitor
2. Pharmacyclics Announces Preclinical Results Supporting Development of Its Novel Btk Inhibitor in Immune Mediated Diseases
3. Pharmacyclics Reports Multiple Presentations at AACR on Its HDAC and Selective HDAC Inhibitors
4. Pharmacyclics Novel Factor VIIa Inhibitor Demonstrates Potential Inhibition of Tumor Growth in Multiple Types of Cancer
5. Pharmacyclics Novel Btk Inhibitor Shows Efficacy in Preclinical Models of Rheumatoid Arthritis and Lymphoma
6. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
7. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
8. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
9. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
10. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
11. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/5/2016)...  Wellbridge Health and Gateway Health proudly announce a dynamic ... and Medicaid plan members with specific high risk needs. ... of this group of consumers, Wellbridge combines technology and population ... insight into members, daily behaviors and lifestyle. ... , , ...
(Date:12/5/2016)... PARSIPPANY, N.J. , Dec. 5, 2016 ... today announced preliminary safety and efficacy data from ... oral selective MDM2 inhibitor, suggesting that DS-3032 may ... relapsed/refractory acute myeloid leukemia (AML) and high-risk myelodysplastic ... part of the phase 1 study of DS-3032 were ...
(Date:12/5/2016)... 2016 Eisai Inc. announced today new analyses ... Meeting of the American Epilepsy Society (AES). ... an adjunctive therapy for the treatment of partial onset ... primary generalized tonic-clonic seizures (PGTC) in patients with epilepsy ... see Important Safety Information for FYCOMPA, including Boxed WARNING ...
Breaking Medicine Technology:
(Date:12/5/2016)... ... December 05, 2016 , ... The new knee compression sleeves ... to buy neoprene knee sleeves for lifting and any sport that requires ... on two main aspects to provide a higher quality knee sleeve performance. Firstly it ...
(Date:12/5/2016)... , ... December 05, 2016 , ... ... today that they have teamed up with The American College of Surgeons (ACS) ... ACS’s Committee on Trauma, the “Bleeding Control Basic” course is a pilot program ...
(Date:12/4/2016)... ... December 03, 2016 , ... ... and many more tools allowing FCPX editors to create professional looking video in ... , Perfect Harmony contains a beautifully designed 3D environment for placing in ...
(Date:12/4/2016)... ... December 04, 2016 , ... "Pro3rd Displace ... animation styles with unique displacement design elements," said Christina Austin - CEO of ... Choose from a variety of design styles that include both left aligned and ...
(Date:12/2/2016)... ... 2016 , ... Halfway through its partnership with First 5 LA, Western University ... than 15,900 children 5 years old and younger and treatment services to more than ... of five years to Western University of Health Sciences, UCLA and USC, beginning March ...
Breaking Medicine News(10 mins):