Biotech Values

[kokostrollet]

Dew, In a nushell, it goes as follows:

ATC is one of the most deadly cancers known to man. Median survival is 4-6 months. See page 122 via this link:

https://www.moffitt.usf.edu/pubs/ccj/v13n2/pdf/119.pdf

OXGN had a complete responder in ATC (only ATC patient) participating in one of their mono phase I trials. This patient is still alive. They now have two trials going on: One mono trial:

http://www.clinicaltrials.gov/ct/show/NCT00060242?order=2

and one first-line combination trial.

http://www.clinicaltrials.gov/ct/show/NCT00077103?order=3

The mono trial has got FTA as well as ODD. However, based on the interrim results from other trials and how ca4p theoretically works as a drug, its potential lies in combination therapy. Here is today´s press release that points out that the combination therapy patients are doing well, but the mono therapy patients do somewhat OK as well although the trial will hardly meet its primary end-point. Question is: How much will it take to convince the FDA to approve anyway (on phase II data) in this disease?

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OXiGENE Announces the Release of Positive Data from Two Phase II Clinical Trials Indicating the Therapeutic Potential of CA4P in the Treatment of Anaplastic Thyroid Cancer (ATC)
Monday June 5, 8:00 am ET


WALTHAM, Mass.--(BUSINESS WIRE)--June 5, 2006--OXiGENE, Inc. (NASDAQ: OXGN, XSSE: OXGN):
Data from a Phase II Clinical Trial Conducted at the Huntsman Cancer Institute of CA4P in Combination with Carbo/Taxol Demonstrates Potential for Improved Patient Benefit in ATC
Investigator from the Ireland Cancer Center in Cleveland Provides Interim Update at ASCO to Data from a Phase II Clinical Trial Evaluating CA4P as a Monotherapy for ATC; 29% of Patients Experience At Least Three-Months of Progression-Free Survival
Research from M.D. Anderson Cancer Center Shows that CA4P in Combination with Chemotherapy Appears to Improve Response in Preclinical Models of ATC
OXiGENE, Inc. (NASDAQ: OXGN, XSSE: OXGN), a leading developer of biopharmaceutical compounds designed to treat cancer and certain ophthalmologic diseases, today announced new, positive data from two Phase II clinical trials that suggest the therapeutic potential of its lead therapeutic compound under development, CA4P, in the treatment of Anaplastic Thyroid Cancer (ATC). The separate trials show patient response, as well as the biological activity of CA4P when CA4P is used either in combination with chemotherapy or as a monotherapy.

The first clinical trial from which data was released is an open-label, Phase II clinical trial of CA4P for the treatment of imageable solid tumors and is being conducted in the United States under OXiGENE's Investigational New Drug (IND) application on file with the Food and Drug Administration (FDA). The trial, conducted by Dr. Wallace Akerley, Director of Clinical Research at the Huntsman Cancer Institute at the University of Utah, evaluates the safety and anti-cancer activity of CA4P-carboplatin-paclitaxel therapy. The trial enrolled individuals with various cancer types, of which two individuals had ATC. Treatment with CA4P in combination with chemotherapy resulted in stabilized disease in one ATC patient and a partial response (greater than 50% tumor reduction) in the second patient. Further, analysis of blood flow volume to the tumors showed a statistically significant and sizeable reduction of more than 73% for both patients. According to Dr. Akerley, both patients failed to respond to alternate therapies within the six months prior to receiving CA4P-carboplatin-paclitaxel therapy.

OXiGENE anticipates that the complete data set for this trial will be released prior to the close of 2006, as patients enrolled in this trial are continuing to receive prolonged therapy.

"In a condition as lethal as ATC, patients who achieve a status of disease stabilization or prolonged periods of progression-free survival are clearly significant clinical accomplishments," commented Dr. Akerley. "Considering the response data generated to-date from CA4P in combination therapy among a variety of tumor types, as well as the compound's favorable safety and tolerability profile, CA4P could offer a distinct advantage over other therapies used to treat ATC."

The patient benefit observed in this trial corroborates preclinical data generated from research conducted by Dr. Sai-Ching Jim Yeung at The University of Texas M. D. Anderson Cancer Center. The data showed biological activity against tumors from two different human ATC cell lines that had been established in mice. Triple combination therapy of CA4P-carboplatin-paclitaxel in both ATC cell lines showed the lowest tumor growth rate of all groups examined in the study, including the single agents and doublet combinations.

Separately, Scot C. Remick, M.D., Professor of Medicine and Associate Director for Clinical Research at the Ireland Cancer Center of University Hospitals of Cleveland and the Case Comprehensive Cancer Center, presented data from a Phase II clinical trial of CA4P monotherapy for the treatment of ATC. The data, which show biological activity of CA4P, support the potential therapeutic benefit that could be gained from CA4P in combination with chemotherapy in this indication. The data were presented in a poster at the American Society of Clinical Oncology (ASCO) Meeting in Atlanta, Georgia.

The poster entitled Phase II study of Combretastatin A4 Phosphate (CA4P) in patients with advanced anaplastic thyroid carcinoma (ATC), reported that 21 patients have been enrolled in the trial to date. From this patient group, 29% experienced progression-free survival greater than three months (survival for patients who benefited ranged from 12 weeks to 84+ weeks). Investigators noted that two patients remain on therapy. One of these individuals appeared to show a dramatic clinical benefit after two cycles of CA4P, with near partial response of metastatic lung lesions significantly decreasing in size or eliminated completely as confirmed by CT scan. Investigators reported that CA4P therapy was well tolerated with no clinically meaningful myelosuppression or cardiac toxicity observed.

Dr. Remick commented on the data, "Without a doubt, we have observed patient benefit from single agent CA4P therapy in ATC. In some cases, patient response has been extraordinary, and supportive of the complete response observed in one patient with ATC who is still cancer free today--more than six years after participating in our initial Phase I clinical trial. We believe that the data presented today provides further evidence of the biological activity of this compound in the treatment of ATC. While more than 25% of patients in this clinical trial have benefited from this therapy, we believe that there is sufficient preclinical and clinical data to suggest enhanced activity from the use of combined modality treatments with CA4P. We believe that additional clinical trials are warranted to investigate the potential clinical benefit of combining CA4P with other therapies, including chemotherapy."

"We are extremely encouraged by all of the data released today which appears to confirm the biological activity of CA4P, and indicate that the compound works synergistically with chemotherapy in ATC," commented Frederick Driscoll, President and Chief Executive Officer for OXiGENE. "It is the culmination of these data, as well as supportive preclinical research from one of the world's leading cancer research institutions, that substantiates that CA4P in combination could be a potentially viable therapy for ATC. We also believe that the current competitive landscape, as well as CA4P's Orphan Drug and Fast Track designations, provide OXiGENE with a potentially expedited pathway to bring CA4P to market in oncology."

CA4P was granted Orphan Drug Designation for the treatment of ATC, as well as medullary, Stage IV papillary and Stage IV follicular thyroid cancers. CA4P also has Fast Track Status by the U.S. Food and Drug Administration (FDA) and Orphan Drug Designation from the European Agency for the Evaluation of Medicinal Products (EMEA) for the treatment of ATC. Currently, there is no approved therapy or treatment standard for ATC in either the US or Europe.

About Anaplastic Thyroid Cancer (ATC)

Anaplastic thyroid cancer is one of the most aggressive types of cancer. ATC represents 3-5% of all thyroid carcinomas, with approximately 700 new cases per year in the United States and an additional 400-900 cases in Europe. Long term survival is rare; median survival for advanced disease is on the order of 4 or 5 months.(1)

About Combretastatin A4P (CA4P)

CA4P leads a novel class of small-molecule drug candidates called vascular disrupting agents (VDAs). CA4P works via two potentially synergistic processes that selectively target pericyte-depleted neovessels, which lack ensheathment from smooth muscle support cells. CA4P is a potent and reversible tubulin depolymerizing agent that causes newly formed endothelial cells that line blood vessels to change shape, round up and detach from the vessel wall. Recent preclinical research has also shown that CA4P disrupts the molecular engagement of VE-cadherin, a junction protein important for endothelial cell survival and function, and inhibits the associated beta-catenin/AKT signaling pathway, leading to rapid vascular collapse and tumor cell death, or necrosis. These complementary mechanisms block the flow of blood to a tumor and deprive it of oxygen and nutrients essential to its survival. Similarly, in eye diseases that are characterized by abnormal blood vessel growth, CA4P has been shown in preclinical studies to suppress development and induce regression of these unnecessary blood vessels.

About OXiGENE, Inc.

OXiGENE is an emerging pharmaceutical company developing novel small-molecule therapeutics to treat cancer and eye diseases. The Company's major focus is the clinical advancement of drug candidates that selectively disrupt abnormal blood vessels associated with solid tumor progression and visual impairment. OXiGENE is dedicated to leveraging its intellectual property position and therapeutic development expertise to bring life saving and enhancing medicines to patients.

(1) American Cancer Society, Cancer Facts and Figures 2006.