0000908259-01-500005.txt : 20011112
0000908259-01-500005.hdr.sgml : 20011112
ACCESSION NUMBER: 0000908259-01-500005
CONFORMED SUBMISSION TYPE: 8-K
PUBLIC DOCUMENT COUNT: 3
CONFORMED PERIOD OF REPORT: 20011031
ITEM INFORMATION: Other events
ITEM INFORMATION: Financial statements and exhibits
ITEM INFORMATION:
FILED AS OF DATE: 20011105
FILER:
COMPANY DATA:
COMPANY CONFORMED NAME: OXIGENE INC
CENTRAL INDEX KEY: 0000908259
STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
IRS NUMBER: 133679168
STATE OF INCORPORATION: DE
FISCAL YEAR END: 1231
FILING VALUES:
FORM TYPE: 8-K
SEC ACT: 1934 Act
SEC FILE NUMBER: 000-21990
FILM NUMBER: 1774953
BUSINESS ADDRESS:
STREET 1: 321 ARSENAL STREET
CITY: WATERTOWN
STATE: MA
ZIP: 02472
BUSINESS PHONE: 6176737800
8-K
1
a8k103101.txt
8-K DATED OCTOBER 31, 2001
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): October 31, 2001
OXIGENE, INC.
-------------
(Exact name of registrant as specified in its charter)
Delaware 0-21990 13-3679168
--------------- ------------- --------------------
(State or other (Commission (IRS Employer
jurisdiction of File Number) Identification No.)
incorporation)
321 Arsenal Street
------------------
Watertown, Massachusetts 02472
---------------------------------------------------
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (617) 673-7800
-1-
Item 5. Other Events and Regulation FD Disclosure.
On October 31, 2001, the Registrant issued a press release, a copy of which is
attached hereto as Exhibit 99.1, announcing that it has completed the Phase I
U.S. clinical trial of its novel anti-tumor vascular targeting agent,
Combretastatin A4 Prodrug (CA4P). The trial generated statistically significant
findings demonstrating CA4P's ability to successfully reduce blood flow that
feeds malignant tumors. CA4P is the first vascular targeting drug to be tested
in a human trial in the United States.
Item 7. Financial Statements and Exhibits.
(c) The following exhibits are filed with this report:
Exhibit Number Description
-------------- -----------
99.1 Press release of Registrant dated October 31, 2001.
99.2 Transcript of conference call conducted by Registrant on
November 1, 2001.
Item 9. Regulation FD Disclosure.
On November 1, 2001, the Registrant held a conference call (the "Conference
Call") to discuss and comment on the completion of the Phase I U.S. clinical
trial of its novel anti-tumor vascular targeting agent, Combretastatin A4
Prodrug (CA4P). A transcript of the Conference Call is attached hereto as
Exhibit 99.2.
-2-
SIGNATURES
----------
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
OXIGENE, INC.
-------------
(Registrant)
Date: November 5, 2001 By: /s/ Frederick Driscoll
-----------------------
Name: Frederick Driscoll
Title: President of Operations and Finance
-3-
EXHIBIT INDEX
-------------
Exhibit Number Description
-------------- -----------
99.1 Press release of Registrant dated October 31, 2001.
99.2 Transcript of conference call conducted by Registrant on
November 1, 2001.
-4-
EX-99
3
pressrel103101.txt
PRESS RELEASE DATED OCTOBER 31, 2001
Ex. 99-1
OXiGENE Announces Successful Completion of its Phase I U.S. Trial of
Combretastatin A4P for the Treatment of Solid Tumor Cancers
Researchers Report Statistically Significant Findings Demonstrating Drug's
Ability to Reduce Blood Flow to Malignant Tumors
Watertown, Massachusetts, October 31, 2001 - OXiGENE, Inc. (Nasdaq: OXGN, SSE:
OXGN), The Vascular Targeting Company, today announced the completion of the
Phase I U.S. clinical trial of its novel anti-tumor vascular targeting agent,
Combretastatin A4 Prodrug (CA4P). The trial generated statistically significant
findings demonstrating CA4P's ability to successfully reduce blood flow that
feeds malignant tumors. CA4P is the first vascular targeting drug to be tested
in a human trial in the United States.
Results will be detailed in a poster presentation this afternoon at the 2001
AACR-NCI-EORTC (American Association for Cancer Research/National Cancer
Institute/European Organization for Research and Treatment of Cancer)
International Conference on Molecular Targets and Cancer Therapeutics in Miami,
Florida. The data show that CA4P can be given safely at doses that significantly
diminish the blood flow to malignant tumors, as evidenced by MRI (magnetic
resonance imaging).
Researchers confirmed a significant reduction in the tumor blood flow in
patients studied 4-6 hours following infusion of CA4P. "We believe that this
Phase I trial provides further evidence of the role that our vascular targeting
agents can play in causing death of existing tumor cells," said Dai Chaplin,
Ph.D., OXiGENE's chief operating officer and head of research and development.
The study, led by Scot Remick, M.D, associate professor of medicine at the
Ireland Cancer Center, University Hospitals of Cleveland, Case Western Reserve
University School of Medicine in Cleveland, Ohio, marked the first completed
U.S. clinical assessment in humans of a vascular targeting agent as an
anti-cancer modality.
A total of 25 patients participated in the Ireland Cancer Center trial. Some
highlights include:
|X| One patient, a 55-year-old man with anaplastic thyroid carcinoma, had a
"pathological complete remission" after undergoing CA4P treatment and has been
disease free for more than two years. |X| Two other patients experienced
"prolonged periods of freedom from progression of their disease," according to
the research.
|X| A patient with colon cancer remained stable for 19 months, while
another with medullary thyroid cancer remained stable for 12 months.
Clinically significant toxicities included tumor pain (two patients) and acute
coronary syndrome (two patients) at the highest dosage levels.
"The drug appears to produce a statistically significant reduction in tumor
blood flow in the patients we studied," Dr. Remick said. "It is certainly rare
to see a `complete responder' in a Phase I clinical trial. Given the absence of
cytotoxic side effects normally seen with traditional chemotherapy drugs, the
research team is enthusiastic about the potential of combining CA4P therapy with
other anti-cancer treatments.
"Additional indication of vascular effect was also noted in this study by the
observation of acute changes in the release of an endothelial cell specific
marker in the blood known as soluble intercellular adhesion molecule-1
(sICAM-1). The changes in sICAM-1 levels that we saw in this study may reflect
rapid endothelial damage and or cell death due to infusion of CA4P. These
results imply that serial measurement of endothelial specific markers such as
sICAM-1 may provide further insight into the effects of vascular targeting
agents on endothelial cell targets," Dr. Remick continued. "We were able to
demonstrate the ability to reduce tumor blood supply at tolerable dosage levels,
without traditional cytotoxic side effects. In short, we were able to
demonstrate the concept of tumor vasculature targeting."
In May, OXiGENE announced final data from its Phase I U.K. clinical trial of
CA4P at the annual meeting of the American Society of Clinical Oncologists. In
that study, which involved 34 patients, CA4P demonstrated a reduction in
malignant tumor blood flow. The dose-limiting toxicity in the U.K. study was
reversible ataxia.
Another Phase I trial, involving 30 patients, also has been conducted at the
University of Pennsylvania. One patient in that study, a 19-year-old with
medullary thyroid cancer, has seen disease stabilization for 19 months. Five
other patients, including two with medullary thyroid cancer, also exhibited
clinically relevant degrees of disease stabilization. The dose-limiting toxicity
in the University Pennsylvania trial was tumor pain.
In both the U.K. and University of Pennsylvania trials, no dose-limiting cardiac
toxicity was observed.
"The findings from OXiGENE's three Phase I trials are very encouraging," said
Dr. Chaplin. "We have demonstrated the drug's proof of principle in that the
drug can interfere with the blood flow in malignant tumors at doses that are
well tolerated and, moreover, we actually have seen clinical responses in
several patients."
Combretastatin A4P is derived from the African bush willow Combretum caffrum.
Unlike their therapeutic counterparts, anti-angiogenesis agents, which inhibit
the formation of new blood vessels in a tumor, vascular targeting agents attack
existing tumor vasculature that supports the primary tumor mass.
Company to Host Conference Call In conjunction with this announcement, OXiGENE
will host a conference call at 10 a.m. (ET) Thursday, November 1. Participating
on the call will be Bjorn Nordenvall, M.D., Ph.D., OXiGENE's chairman and chief
executive officer, Dr. Chaplin and Dr. Remick.
To access the conference call, please dial (800) 354-6885 (domestic) and (212)
346-0123 (international) five minutes prior to the scheduled start time. A
48-hour replay of the call will be available by calling (800) 633-8284
(domestic) and 858-812-6440 (international). Please refer to reservation number
19938507.
The conference call also is available by logging on to:
http://web.servicebureau.net/conf
/meta?i=1112300747&c=2343&m=was&u=/w_ccbn.xsl&date_ticker=11_1_2001_OXGN
--------------------------------------------------------------------------------
About OXiGENE
OXiGENE, an international biopharmaceutical company, is the world leader in
vascular targeting agents that destroy existing blood vessels associated with
cancerous tumors, and which may have an application in the treatment of
restenosis and certain forms of ocular disease. With its flagship family of
Combretastatin-based vascular targeting agents, OXiGENE is developing a diverse
portfolio of innovative products to combat these conditions. The Company's
mission is to in-license new therapeutics from academic partners, and develop
new drugs that will enhance the effectiveness of traditional cancer treatments
and to introduce innovative therapies that attack cancer and other diseases.
This news release contains "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995. These statements include,:
the efficacy, safety and other findings of the Phase I trials of Combretastatin
A4P conducted in the United States and abroad; the potential benefits of
OXiGENE's vascular targeting agents in cancer treatment and other diseases
including certain forms of ocular disease and, restenosis; and the benefits of
combining CA4P with other forms of cancer treatment. Any or all of the
forward-looking statements in this press release may turn out to be wrong. They
can be affected by inaccurate assumptions we might make or by known or unknown
risks and uncertainties including but not limited to, the early stage of our
product development and the unproven efficacy of our technology and at
acceptable dosage levels; our ability to raise capital when needed and on
reasonable terms; uncertainties as to the future success of ongoing and planned
clinical trials; our dependence on others for much of the clinical development
of our technology, as well as for obtaining regulatory approvals and conducting
manufacturing and marketing of any products that might successfully reach the
end of the development process; competition from other companies and other
institutions pursuing alternative technologies; and uncertainties related to our
ability to obtain adequate intellectual property protection for our technology
and products. Consequently, no forward-looking statement can be guaranteed and
actual results may vary materially. Additional information concerning factors
that could cause actual results to materially differ from those in the
forward-looking statements are contained in our reports to the Securities and
Exchange Commission including our 10-Q, 8-K and 10-K reports. We undertake no
obligation to publicly update forward-looking statements, whether as a result of
new information, future events or otherwise, except as may be required by law.
Contact:
OXiGENE, Inc. or Sharon Merrill Associates, Inc.
Tammy Bishop David Calusdian (Investors)
Director of Investor Relations and Scott Solomon (Media)
Corporate Communications (617) 542-5300
(617) 673-7826 dcalusdian@investorrelations.com
tbishop@oxigene.com ssolomon@investorrelations.com
EX-99
4
trans110101.txt
TRANSCRIPT OF NOVEMBER 1, 2001 CONFERENCE CALL
Ex. 99-2
OXIGENE
Moderator: Dr. Bjorn Nordenvall
November 1, 2001
8:00 a.m. MT
Operator:
Good day, and welcome to the Oxigene phase one clinical trial result
conference call. Today's call is being recorded on Thursday, November
1st, 2001.
With us from the company are the chairman and chief executive officer,
Dr. Bjorn Nordenvall, and the chief scientific officer, Dr. Di Chaplin
[sp]. Also participating in today's call is Dr. Scott Remick [sp],
associated professor of medicine at the Ireland Cancer Center, at
University Hospitals of Cleveland, and Case Western Reserve University
School of Medicine in Cleveland, Ohio. I would now like to turn the
conference to Tammy Bishop [sp], Oxigene's director of investor
relations and corporate communications. Please go ahead.
Tammy Bishop:
Thank you and good morning. Before we begin I would like to remind
everyone that various remarks we make about future expectations, plans
and prospects for Oxigene constitute forward-looking statements for
purposes of the safe harbor provision under the Private Securities
Litigation Reform Act of 1995. Actual results may differ materially
from those indicated by these forward-looking statements as a result
of various important risk factors including those discussed in our
Form 10K for the fiscal year ended December 31, 2000, and out other
reports on file with the Securities and Exchange Commission.
Let me outline the format for today's call. First, Dr. Nordenvall will
briefly summarize the phase one clinical trial results and then he
will turn the call over to Dr. Di Chaplan who will provide an overview
of Oxigene's vascular targeting strategy. Dr. Remick will go into the
results of his clinical trial in more detail and then we will take
your questions. With that I will turn the call over to Dr. Nordenvall.
Dr. Bjorn Nordenvall:
Thank you, Tammy. As I'm sure many of you saw yesterday morning we
issued a news release announcing the successful completion of our
phase one U.S. trials of Combridistatin A4 Pro Drug [sp] for the
treatment of various assorted tumor cancers. These results were based
on the clinical trial of 25 patients conducted at the University
Hospital of Cleveland. Dr. Di Chaplan and I are extremely pleased to
be joined on today's call by the trial's principle investigator, Dr.
Scott Remick, associate professor of medicine at Case Western and
program leader for the development therapeutics at Cleveland's Ireland
Cancer Center.
Before Dr. Scott Remick discusses his findings I will turn the call
over to Dr. Di Chaplan who will take a moment to explain the
importance of the phase one data to [unintelligible] Oxigene and
discuss our vasculatory [unintelligible].
Dr. Dai Chaplan:
Thank you, Bjorn. Oxigene's flagship compound, Combridistatin A4 Pro
Drug [sp], was discovered by Dr. Bob Pettit [sp] from Arizona State
University. Oxigene licensed the family of Combridistatin compounds
from Arizona State University in 1997. Unlike their therapeutic
counterparts, anti-antigenic agents [sp], which attempt to inhibit the
formation of new blood vessels in a tumor, vascular targeting agents
attack existing tumor vasculature that support the primary tumor mass.
Oxigene has completed three phase one trials with Combridistatin A4
Pro Drug. The phase one clinical trial is designed to evaluate the
safety and potential toxicities of the compound being evaluated to
determine dosage tolerance and other factors that answer the question-
can the drug be administered safely.
In our phase one study of Combridistatin A4 Pro Drug researchers not
only demonstrated that the drug can be administered safely; they also
observed through magnetic resonance imaging a statistically
significant reduction in blood flow within the tumor four to six hours
after the infusion of Combridistatin A4 Pro Drug. Remember that
Combridistatin A4 Pro Drug is the first vascular targeting drug to be
tested in the human trial in the United States so to be able to
generate these kind of results is a significant achievement.
It is also critical to note that this blood flow reduction within the
tumor occurred without the Cytotoxic [sp] side effects seen with
traditional chemotherapy drugs. This leads researchers to believe that
Combridistatin A4 Pro Drug will be able to work effectively in concert
with other anti-cancer treatments. Our strategy is to develop a family
of vascular targeting agents that attack the blood vessels that feed
tumor cells. Combridistatin A4 Pro Drug represents the initial step in
our core strategy. We believe that a vascular targeting agent approach
to treatment will prove effective, more targeted, and therefore less
toxic than traditional cancer therapies. It is our aim to rapidly
accelerate clinical development of Combridistatin A4 Pro Drug with a
phase 1B study in combination with chemotherapy or radiation and a
phase two trial as a monotherapy.
Now, I'd like to introduce Dr. Scott Remick of Case Western Reserve
University School of Medicine.
Dr. Scott Remick:
Thank you, Di. [break in audio] trial and as previously mentioned by
Bjorn I am the PI of the study. I might also add that this was the
first study conducted in the United States in patients with this agent
and it laid the groundwork for another trial that was conducted at the
University of Pennsylvania to start and Di can respond to questions
regarding the other studies involved with this compound.
This would be a good opportunity to walk you through our clinical
trial and briefly highlight certain important clinical aspects of the
study. First, our study objectives- our primary objective was to
determine the MTD and I will reference that throughout the call. MTD
stands for the Maximum Tolerated Dose of Combridistatin A4P when given
as a single IV dose at three-week intervals. It's also pertinent to
remind you that oftentimes when a drug is tested in humans for the
first time you do need single dose pharmacokinetics.
Secondary objectives included to determine both the toxicity and dose
limiting toxicity of Combridistatin A4P to determine the plasma
pharmacokinetics as I alluded to, to obtain preliminary efficacy data
and importantly, which we'll also spend a little bit of time on the
call which is quite interesting, is to evaluate the effects of
Combridistatin A4P on tumor blood flow and cell adhesion molecules at
the MTD when possible which substantiates the biological effect of the
drug.
In our trial we've enrolled a total of 25 patients- half of- 12
patients were males, 13 females, median age was 55 years of age. The
majority of patients had good performance status. That is, they were
physically doing reasonably well in terms of their cancer and how they
were feeling on a day to day basis with ECOG [sp] performance status
of zero or one. That's often a clinical designation. The majority of
our patients also had received prior therapy. Only two patients of the
25 did not have any prior therapy.
We had a very broad range of common cancer histologies on our trial
that you normally see in a phase one trial with the exception of
perhaps thyroid cancer where we had five patients. We had colon
cancer, pancreatic melanoma, sarcoma, renal, lung, breast and so
forth. And all of these patients had advanced disease.
Our dose escalation proceeded over four dose levels. We had a starting
dose of 18 milligrams per metered square given as an intravenous
infusion for 10 minutes. The dose was escalated to 36 milligrams, 60
milligrams, 90 milligrams. We also expanded the 60 milligram cutwork
to look at the drug given as a one-hour infusion. Overall we had 25
patients, as I stated, and they received a total of 107 cycles of
treatment.
I will briefly comment on some unique aspects on the clinical toxicity
profile of the drug. It is important to emphasize that the drug did
not appear to have the typical side effect profile that you see with
cytotoxic agents. That is, there was no significant mylo [sp]
suppression. There was no significant hair loss or stomatitis [sp]
which is soreness of the mouth or diarrhea, gastrointestinal track
problems per se. And the drug did appear to demonstrate a vascular
profile that the drug was vascular active. We saw a variable symptom
complex across all dose levels including hot flash, [break in audio],
changes in blood pressure and heart rate and interesting tumor pain
which might be reflective of the mechanism of action.
Importantly, we decided to measure blood flow in our patients to
actually prove proof of principle based on animal models we
extrapolated into the clinic to try to obtain follow up MRI studies in
our patients between four to six hours of dosing. In addition, we also
collected plasma samples to look at various cell adhesion molecules
which are molecules that we can measure in the plasma that may be
indicative of endothelial cell injury, and endothelial cells are the
lining cells of both normal and tumor blood vessels.
Results with our MRI studies- six of seven patients we identified a
significant reduction in tumor blood flow. This occurred in six out of
seven patients and it ranged from 15 percent to approximately 50-55
percent reduction in tumor blood flow. Interestingly as well, we did
confirm that we could measure a marker in the serum, that being
intracellular cell adhesion molecule ICAM [sp] that insignificantly
increased in patients when you compared a pre-treatment level to both
the one-hour and 24-hour post treatment level, suggesting that the
drug may be acting on endothelium causing endothelial injury.
We did encounter dose limiting side effects, dose limiting toxicity.
Two patients at the highest dose level- two patients out of three had
some dose limiting toxicity. The first was an episode of shortness of
breath and the other episode was a completely reversible episode of
coronary vasospasm. We reduced to 60 milligrams also looking at a
10-minute and 60-minute infusion as I said at the outset. We had
another patient that did have some pulmonary side effects with
shortness of breath and tumor pain and subsequently respiratory
strider [sp] and another patient that had cardiac eschemia that was
entirely asymptomatic. I might add that all episodes of dose limiting
toxicity were completed reversible and patients recovered without any
significant [unintelligible].
I touch briefly as well that given the vascular profile of this drug
this is exciting to see that indeed based on the laboratory
[unintelligible] studies and the clinical side effects that indeed it
is possible to administer a drug systemically that does appear to act
on the tumor vessels.
Perhaps the most exciting aspect of our trial is that it is indeed
unusual for a drug to enter the clinic for the very first time and to
have evidence of clinical activity or efficacy. At our very first dose
level, one patient with renal cancer had a freedom from progression of
six months. Another patient at dose level two, the 36 milligram per
metered squared level had a minor response, had a 34 percent reduction
in tumor after two cycles, and these are patients that were heavily
pretreated. At dose level three you have heard by now we had a patient
with anaplastic [sp] thyroid cancer that has had a pathological
complete remission. He remains alive now more than two years since
completing Combridistatin therapy and is doing extraordinarily well.
We had another patient on dose level three as well with mebullary
thyroid cancer, a young woman, who had prolonged freedom from
progression or stable disease at 12 months and at the highest dose
level a patient did get dose reduced given the side effects we
encountered in other patients. A woman with metastatic colon cancer
had a prolonged freedom progression in excess of a year and a half. I
think the observation about prolonged freedom of progression is
certainly very very important to clinicians and to folks involved in
treating cancer patients because it is clear that perhaps agents that
are vascularly active or angiogenisis [sp]-- we might be looking at a
new paradigm in the clinic where freedom from progression of disease
may in fact be as important if not more important than an objective
tumor response.
So with that I think we can conclude from our study that the safety
profile of Combridistatin A4P is consistent with an agent that is
vascularly active and not cytotoxic. We clearly have demonstrable
clinical efficacy seen early in the clinical development of this
compound. The upper boundary of the maximum tolerated dose in our
particular study approaches between 50 and 60 milligrams per metered
squared on a single IV administration at three-week intervals and is
consistent, which Di might be able to comment on, from observations on
the other two phase one studies of this compound.
Our MRI blood flow studies have confirmed an approximate 15 to 50
percent range of reduction in tumor blood flow that was statistically
significant in six of seven patients. There was a statistically
significant increase in serum ICAM pre- and post-treatment with CA4P
which is indicative of endothelial cell injury and biological effect.
And clearly, Combridistatin A4P from our vantage point is an
attractive agent to combine with other antiangeogenisis agents,
cytotoxic agents and other modalities, perhaps radiation, and
continued development of the compound is warranted to sort out the
optimal dose and schedule as well. So thank you for asking me to
participate in this call and I'll be glad to answer any questions.
Tammy Bishop:
Thank you, Dr. Remick. Operator, would you please open the call up to
questions?
Operator:
Yes, ma'am. Thank you. Ladies and gentlemen, if you want to register a
question for today's question-and-answer session you will need to
press the one followed by the four on your pushbutton phone. You will
hear a three-tone prompt acknowledging your request. If your question
has been answered or you would like to withdraw your polling request,
you may do so by pressing the one followed by the three. And if you
are using a speakerphone, please pick up your handset before entering
your request. Once again, ladies and gentlemen, if you do have a
question, please press the one followed by the four. The first
question is from Scott Herstin with U.S. Trust Company of Florida.
Please go ahead.
Scott Herstin:
Good morning, gentlemen. Thanks for the report. Nice to see a good
flow of information again after a long drought. Would you be good
enough, any of you, to lay out the plan going forward, mostly having
to do with the timing of initiation of the 1B and of the phase two
monotherapy and what can we expect for roll out, completion, et
cetera. Not holding you to any dates obviously, but putting it in a
timeframe for us.
Dr. Dai Chaplin:
OK. I'll- I mean I've stated our plans are to move Combridistatin
through the next phase of clinical trial. The primary emphasis will be
on initiating a phase 1B on combination with existing chemotherapy.
But in addition we plan, based on responses seen to date, to evaluate
Combridistatin A4 Pro Drug as a monotherapy in at least one tumor
type.
We anticipate these trials will be initiated in 2002, next year. The
exact timeframe and design of the trials will be defined clearly when
we reviewed all the data available from BMS. We clearly- that data
will be transitioned to us over the next few weeks and that will
determine exact timing. But we anticipate that the trials will begin
next year.
Scott Herstin:
OK, thank you.
Operator:
Your next question is from Warren Libman with Libman Consulting.
Please go ahead.
Warren Libman:
Yes. Gentlemen, thank you for taking my questions. I have several so
I'll ask the questions all together and then you can answer them in
any order you like. First question is I believe there was a Dr.
Faulkner [sp] in this area, Miami area, who was also doing the same
kind of research. Where does your company stand with regard to what
they might be doing that was similar to what you're doing? And by the
way, congratulations on your results. The other question I have is I
think about a week ago Bristol Myers pulled away from your company and
I think you indicated that you were looking for another company to
participate with, perhaps for capitalization. Is there a problem with
capitalization and how do you foresee what other company might be
involved? Thank you.
Dr. Dai Chaplin:
I think [unintelligible] the first question regarding people doing the
same work. Our field is vascular targeting. Our major, if you like,
the major players and the major competitors in this field now emerging
are Astrozenica [sp] who have got an agent that works by a similar
mechanism and also Aventis [sp]. There are no other compounds or
agents near the clinic at the moment. There are vascular targeting
agents and in fact both Astrozenica and Aventis are still behind us in
terms of clinical development.
Dr. Bjorn Nordenvall:
OK. And I could answer the second question which was with regard to
Bristol Myers and our relationship with them and also if we are
looking for new partners. And starting with Bristol Myers, the
agreement was concluded because Combridistatin compounds were no
longer consistent with Bristol Myers' strategic profile for the drug
development and we were able to negotiate last week and have announced
that we now have regained all the rights to this technology and we
have started this week now to initiate discussions with potential new
partners.
So our primary focus right now within Oxigene is to do exactly what Di
Chaplan here said. It's to move as quickly ourselves now into further
clinical trials, phase two and also in combination and in parallel
start discussions with the aim of finding a partner who will help us
to take this drug and this technology forward in an aggressive way.
Warren Libman:
Thank you.
Operator:
Your next question is from James Ladoucer, a private investor. Please
go ahead.
James Ladoucer:
Hello. I have a question for Dr. Remick. You mentioned in your
abstract that you have some evidence of cardio toxicity. How would you
characterize this and how concerned are you that this could be a major
problem for the compound?
Dr. Scott Remick:
That's part of the reason behind doing a phase one trial is to
determine what the side effect profile of any given agent is. Without
going into a lot of details that we certainly shared at this meeting
for purposes of brevity on the call, one of the episodes was an
episode of coronary vasospasm which we think likely could be
implicated or directly related to the drug. The second episode of
cardiac eschemia- there are mitigating factors in terms of an elderly
man that did indeed prove to have underlying cardiac disease and this
has been encountered in another patient described in another trial,
not of Combridistatin.
So I think that the take home message that, you know, we have to learn
about the side effect profile. We have to see if we can lessen the
side effects and for that matter if we can manage or prevent the side
effects, specifically cardiac toxicity. But from my vantage point as a
clinical investigator and a cancer clinician, the activity that we've
seen early in our phase one trial- I think we're obligated- it would
be imperative to strategically continue to move forward and develop
this drug because it appears to have early on significant clinical
activity and certainly needs to be substantiated in future studies and
similarly the side effect profile will be- will declare itself in
future studies.
Dr. Dai Chaplin:
If I can just add to that, Scott, I mean I think that if we look at
the other studies that have been done with Combridistatin in all in
the three studies we have included nearly 100 patients. We've had two
instances of cardiac toxicity, both in the study in Cleveland, which
Scott has reported in full today.
James Ladoucer:
Thank you.
Operator:
The next question is from Thomas Gordon, a private investor. Please go
ahead.
Thomas Gordon:
Hi. First of all, congratulations on the results. They're very
exciting. In one of your- some of the recent press releases it was
described as the termination with BMS as a setback for your company.
I- my reaction was if Bristol Myers was not going to aggressively
pursue development of Combridistatin, one of the results is that now
you control your own destiny and that you can move this drug along
much more aggressively. I guess my only concern- I wish- some of my
comment on this is does your capital position put any limitations on
that over the near term?
Dr. Bjorn Nordenvall:
OK. I can answer that. Our cash position today is that we have $20
million U.S., about that in the bank. We expect the burn rate next
year to be $10 million so we have about two years of cash. And the
reason [unintelligible] is that we have a lean infrastructure and very
controlled spending. And the way we see it right now is that we have
now enough money to do exactly what you said, speed up the
development. That-- what we also now have started already to do is to
identify a new partner that could help us to achieve our goal.
Thomas Gordon:
Thank you.
Operator:
The next question is from Tom Brown, a private investor. Please go
ahead.
Tom Brown:
Hi, how are you? This question is for Dr. Remick. As you discussed in
your results, you treated various types of cancers with CA4P. Going
ahead- looking ahead in the future, do you see any types of candidate
that would be better or would be more appropriate than others to treat
in the phase 1B or in the phase two?
Dr. Scott Remick:
Well, I think just in general you could almost argue as we're learning
more and more about the implications of angiogenesis and cancer in
general that you could argue that almost any solid tumor may be
amenable to such an approach. Based on our early observations, not
only in our study but I believe also the [unintelligible] study that
Di might want to be able to comment on, there appears to be some
activity early in the phase one setting in thyroid cancer and if our
results are replicated this would be a major breakthrough for patients
with thyroid cancer since there's really no effective therapy for
those patients, certainly with the high grade form of the disease.
I think that our observations in a woman with colon cancer and the
fact that she had a 19 month freedom from progression is also a
worthwhile observations, so that's a more common tumor site or primary
site and there's a suggestion of a little bit of activity in other
solid tumors. I think certainly Oxigene will be getting additional
clinical data about efficacy in other tumor types as they launch their
phase 1B studies and the plan is I think to look at this drug
specifically as monotherapy in thyroid cancer.
Dr. Dai Chaplin:
I'll just address it- I mean [break in audio] radiation. I think that
that's the exciting area for it and that's applicable to all tumor
types. I think what surprised us in this phase one study is the fact
that we have seen activity as a single agent in certain tumor types
and I think in addition to the data that Scott provided, the data
[unintelligible] that was done by Peter O'Dwyer [sp] we still have a
patient on the study with [unintelligible] 18 months out who has
stable disease.
So I think we have shown the that the drug has activity as a single
agent in certain cancer types. [unintelligible] activity we think and
believe in all tumor types when it's used in combination with other
therapy. And that's why we're going forward [inaudible] going forward
with two different approaches, one in combination but also to look at
it as a single agent based on the activity we've seen in the phase one
trials.
Tom Brown:
Thank you, sirs.
Operator:
Your next question is from Scott Herstin with U.S. Trust Company of
Florida. Please go ahead with your follow-up questions.
Scott Herstin:
Gentlemen, another question and I'm not sure I'm using the terms quite
correctly, but what would you need to demonstrate in order to get the
orphan drug designation which my understanding is that you then
accelerate FDA approval or then proceed on a faster track for
commercialization for a specific use, perhaps in this case thyroid
cancer. Could you talk about that?
Dr. Dai Chaplin:
[crosstalk] Yeah, I think that, you know, clearly if there's an
incidence of disease that's relatively small in terms of instance
rates where thyroid and some other types of cancer would fit into that
bracket, then clearly one can go forward in terms of orphan drug
status. That gives you the possibility of going forward on a fast
track basis. And then once it's approved, clearly it can be used off
label for other diseases but it provides a way of fast tracking the
drug in certain disease types and clearly that's a possibility which
we're looking at based on the data we've seen in the phase one trial.
Scott Herstin:
OK, thank you.
Operator:
If there are any additional questions, please press the one followed
by the four on your telephone.
The next question is from James Ladoucer, a private investor. Please
go ahead with your follow up.
James Ladoucer:
Hello, I have a question for Dr. Nordenvall. You mentioned as a result
of refocusing the company towards vascular targeting that you decided
to stop the development of Daclopermine [sp]. Could you comment on
that? Why you decided to do so?
Dr. Bjorn Nordenvall:
Yes. The reason is this is a clear business decision we have taken.
Earlier this year we out licensed other internal technology and we are
strategically moving the company now, focusing entirely on
Combridistatin and our vascular targeting technology. What we will do
now is to consider out licensing [unintelligible] also now for the
Daclopermine and these discussions have now started.
James Ladoucer:
Thanks.
Operator:
Once again, if there are any additional questions, please press the
one followed by the four.
I am showing no further questions at this time. Please continue with
your presentation or any closing remarks you may have.
Dr. Bjorn Nordenvall:
Thank you.
Dr. Bjorn Nordenvall:
Thank you all for participating in today's conference call and a
special thanks to Dr. Scott Remick for taking this time to join us
today to discuss the significant findings. Obviously [unintelligible]
Combridistatin A4 products. We hope that today's conference has been
useful and we look forward to updating you all on the progress being
made at Oxigene. Good day.
Operator:
Ladies and gentlemen, that does conclude your conference call for
today. You may all disconnect and thank you for participating.