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Biotech / Medical : OXIGENE INC. (OXGN) -- Ignore unavailable to you. Want to Upgrade?


To: nigel bates who wrote (239)8/20/2001 11:54:52 AM
From: nigel bates  Respond to of 273
 
And, FWIW, the associated PR -

WATERTOWN, Mass. & STOCKHOLM, Sweden--(BW HealthWire)--Aug. 20, 2001--OXiGENE, Inc. (NASDAQ: OXGN, SSE: OXGN), the vascular targeting company, today announced an interim update on their collaboration with Bristol-Myers Squibb to develop the Combretastatin compounds as a new class of anticancer agents.
    In March of 2001, BMS began coordinating a Phase I safety trial of CA4P, one of the Combretastatin compounds, at sites in the United States. This trial is open to patients with certain types of solid tumors. Patients in this Phase I trial will receive CA4P alone. The aim of this Phase I study is to obtain the maximum amount of data to determine the optimal dose and dosing schedule for continued development of the drug. The Phase I trial is expected to complete enrollment by early next year.
    In December of 1999, OXiGENE entered into a research and collaboration agreement with Bristol-Myers Squibb for the development and commercialization of vascular targeting agents including CA4P for the treatment of cancer. Upon the completion of this current Phase I trial the next phase of clinical development will commence. We would expect that to occur in the first half of 2002 although we cannot control the developmental timetable which rests with our collaborator Bristol-Myers Squibb.
    Combretastatin compounds, such as CA4P, are the first in a new class of agents called vascular targeting agents. These compounds appear to selectively target existing blood vessels at tumor sites, thereby cutting off the tumor's blood supply and depriving it of oxygen and the nutrients necessary for its survival and growth. CA4P is being developed for potential use either as a stand-alone therapy for solid tumors that require blood vessels for survival, or for combination therapy with chemotherapy or radiation to enhance the effectiveness of these traditional cancer treatments.
    "We are very satisfied with BMS's clinical development of CA4P. We are pleased to be working with the world leader in oncology on this important new approach in treating cancer", stated Bjorn Nordenvall, M.D., Ph.D., Chairman and Chief Executive Officer of OXiGENE.
    OXiGENE's initial Phase I clinical trials have shown CA4P's ability to reduce blood flow to the tumor, as measured by magnetic resonance imaging, thereby attempting to inhibit the tumor's survival and growth. The studies are the first demonstrations in human clinical trials of an inhibitor that reduces the flow of blood within tumor-associated blood vessels.
    "Phase I results from OXiGENE's European trial have shown that we can administer CA4P to humans at well tolerated doses that cause a significant decrease in blood flow to tumors" said Dr. David Chaplin, Chief Scientific Officer and Head of Research, OXiGENE, Inc. " We are excited that similar results were seen in the preliminary data from OXiGENE's two initial US Phase I trials."...



To: nigel bates who wrote (239)8/20/2001 7:29:28 PM
From: Miljenko Zuanic  Read Replies (1) | Respond to of 273
 
<<Announced 11 minutes before the event?
Great news management...>>

They are so thirsty for though question! <g>

My impression on CC:

<<- There have been NO drug related fatalities>>

How about cardiac or trombotic event?

<<- BMS's P1 trials are ongoing & open for recruitment; have not been halted by the FDA.>>

What about modified by FDA, or on suggestion of the SMB? Or modified by BMS?

<<- As for time taken over P1 trials, they repeatedly stressed that they are able to monitor drug activity (by monitoring tumor blood flow) as well as toxicity during P1 trials. They suggested that this will give BMS sufficient data to be able to conduct quicker P11 trials.>>

Seams to me that BMS are applying special technique primarily for monitoring drug side effects (CA4P interaction with normal vasculature/tubulin), than for tumor activity.

Anyway, BMS will need two years to correct and fix what OXGN was done wrong in their 100 pts three PI trials. At the end (my speculation) they may have safe but an-effective dose. CA4P may be a good drug to STUDY (fast and short action, irreversible one) tubulin targeting agent, which may be only BMS attention at this time. And OXGN will never found what went wrong?

Miljenko