Navigation Links
Tigris Pharmaceuticals Initiates Randomized Phase 2 Study of AFP-464 in ER-Positive Breast Cancer Patients

BONITA SPRINGS, Fla., May 26, 2011 /PRNewswire/ -- Tigris Pharmaceuticals, Inc., today announced enrollment of its first patient in a randomized Phase 2 clinical trial of AFP-464 (aminoflavone prodrug) with or without Faslodex® (fulvestrant) in estrogen receptor (ER)-positive breast cancer patients. Molecular profiling will be used to pre-screen patients for a biomarker called Aryl Hydrocarbon Receptor (AhR), which has shown to predict sensitivity to AFP-464.

It is estimated that approximately 70 percent of breast cancers are ER-positive (1).

"The promise of personalized medicine is being realized with this study of AFP-464," said Edmundo Muniz, M.D., Ph.D., president and chief executive officer of Tigris Pharmaceuticals. "Matching specific markers and gene variations to particular medicines is a more efficient way of developing new anti-cancer agents and more importantly, will enable doctors to make more informed prescribing decisions, reducing risks of side effects and increasing chances of treatment success."

The primary endpoint of the study is to determine the percentage of patients that achieve a Clinical Benefit Response.

The randomized, proof-of-concept trial is led by Joanne Blum, M.D., Ph.D., director of the Hereditary Cancer Risk Program at Baylor-Sammons Cancer Center in Dallas, Texas. The study is open for accrual with the US Oncology Research Network, the largest community-based cancer research network in the nation.

"We are fortunate there are approved therapies to treat metastatic breast cancer, but the majority of patients with this disease will become refractory during  treatment," said Dr. Blum. "This study is exciting in that it may have the potential to improve our ability to deliver targeted cancer therapy at the outset of treatment providing another option for these patients.  Additionally, this agent may help to overcome endocrine resistance, one of the major problems for patients with ER positive metastatic disease."

About AFP-464

AFP-464 is a novel anti-cancer agent currently being studied by Tigris Pharmaceuticals in a randomized Phase 2 clinical trial with ER-positive breast cancer patients.  AFP-464 is also being studied by the National Cancer Institute ("NCI") under a Cooperative Research and Development Agreement (CRADA). NCI is sponsoring two  Phase 1 clinical trials in patients with solid tumors under the CRADA. Pre-clinical studies into AFP-464's mechanism of action have shown that AFP-464 is converted to metabolites, which bind covalently to DNA, resulting in p53 activation and apoptosis. AFP-464 has shown a unique pattern of growth inhibitory activity in the NCI's 60 tumor cell line screen, with breast, ovarian, lung and renal tumor cell lines exhibiting particular sensitivity to the compound. In vivo anti-tumor activity of AFP-464 has been demonstrated in several xenograft studies in mice bearing renal and breast cancer. Pre-clinical studies have shown that tumors (breast, ovarian, pancreatic and renal) with AhR localized in the cytoplasm are very sensitive to AFP-464 while those with AhR localized in the nucleus are more resistant.

About Tigris Pharmaceuticals, Inc.

Tigris Pharmaceuticals, Inc. is a privately held biopharmaceutical company that acquires, develops and commercializes innovative specialty care therapies to treat oncology, pain, inflammation, acute and supportive care areas of unmet medical need. Tigris' mission is to efficiently move its existing and future technologies through the various stages of clinical development in order to meet patients' needs for safe and effective treatments of human illnesses.


Alexander Mironov
Vice President of Operations
Tigris Pharmaceuticals, Inc.
(239) 444-5400

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are valid only as of today, and we disclaim any obligation to update this information. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other governmental regulation, our pharmaceutical collaborator's ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third party reimbursement, and other factors described in our filings with the Securities and Exchange Commission.


SOURCE Tigris Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Tigris Pharmaceuticals, Inc. Completes $6.5 Million Private Placement
2. Tigris Pharmaceuticals Appoints Neil Flanzraich to Executive Chairman of the Board
3. Tigris Pharmaceuticals Signs CRADA with the National Cancer Institute
4. Tigris Pharmaceuticals Initiates Phase I Study of AFP-464 in Patients with Solid Tumors
5. Savient Pharmaceuticals Marketing Authorization Application for KRYSTEXXA® Accepted for Review by European Medicines Agency
6. Tragara Pharmaceuticals Apricoxib Reverses EMT, a Key Process for Cancer Progression and Metastasis
7. Aeolus Pharmaceuticals, Inc. to Present Live, Online at on June 2nd
8. Endo Pharmaceuticals Holdings Inc. Announces Proposed Private Offering of Senior Notes
9. Reportlinker Adds Global: Pharmaceuticals Industry Guide
10. Meta-Analyses of Phase 3 Trials Show Obese and Overweight Patients Taking Arena Pharmaceuticals Lorcaserin Achieved Statistically Significant Weight Loss
11. Amylin Pharmaceuticals Obtains Temporary Restraining Order Against Eli Lilly
Post Your Comments:
(Date:11/24/2015)... Nov. 24, 2015  Thanks to a donor with ... Mary,s Medical Center,s Sister Diane Grassilli Center for Women,s ... in San Francisco . ... stepped forward with a gift of $617,320 that allowed ... Mammography with Tomosynthesis and Whole Breast Ultrasound. Tomosynthesis, three-dimensional ...
(Date:11/24/2015)... 24, 2015  Array BioPharma Inc. (Nasdaq: ... Officer, Ron Squarer , will present at ... York.  The public is welcome to participate in ... BioPharma website.Event:Piper Jaffray Annual Healthcare ConferencePresenter:  , Ron ... 2015Time:1:30 p.m. Eastern Time Webcast: , ...
(Date:11/24/2015)... and VANCOUVER, Nov. 24, 2015 /PRNewswire/ - ESSA ... EPIX ) announced today that the first patient ... of EPI-506 as a treatment for metastatic castration-resistant prostate ... and Canada.  --> the ... In the Phase 1/2 clinical trial, ESSA intends ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... November 25, 2015 , ... "When I underwent ... bras were incredibly uncomfortable," said an inventor from Bronx, N.Y. "In order to ... the patent-pending RECOVERY BRA for added comfort and support. The bra is easier ...
(Date:11/25/2015)... ... November 25, 2015 , ... Bcureful—a non-profit organization devoted to ... raising public awareness of the disorder while helping to bring expert medical care ... to bolster progress at the Tuberous Sclerosis Complex Center at Ann & Robert ...
(Date:11/24/2015)... Florida (PRWEB) , ... November 25, 2015 , ... ... planning and monitoring. Their Care Plan software creates an agreement between the ... patient care plan, including financial, scheduling, monitoring, notification, and projections. Click ...
(Date:11/24/2015)... ... November 24, 2015 , ... Young patients with a ... Dr. Angela Wolfman and Dr. Kedar S. Lele, who are pediatric dentists in ... and fillings, the WaterLase iPlus 2.0™ system causes minimal discomfort and bleeding to the ...
(Date:11/24/2015)... ... November 25, 2015 , ... ... solutions for drugs, biologics, consumer health and global clinical supply services, today announced ... upcoming Clinical Trial Supply East Asia Conference, to be held at the InterContinental ...
Breaking Medicine News(10 mins):