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U.S. 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): November 26, 2007
ONCOLOGIX TECH, INC.
(Name of Small Business Issuer as Specified in Its Charter)
0-15482
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(Commission File Number)
Nevada 86-1006416
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(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
3725 Lawrenceville-Suwanee Rd., Suite B-4
Suwanee, GA 30024
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(Address of principal executive offices)
(770) 831-8818
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(Issuer's telephone number)
Check the appropriate box below if the Form 8-K is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
[ ] Written communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17
CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
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Item 8.01 Other Events.
On November 26, 2007, the Company completed animal studies with rabbits
that satisfied four of the six requirements believed to be necessary for IDE
submission to the FDA with respect to the animal studies for the Oncosphere
product. The remaining two objectives were not satisfied with the rabbit studies
because the structure of the rabbit anatomy does not provide an adequate
representation of human anatomy to evaluate the Oncosphere for the two remaining
objectives. The blood vessels of the rabbit are too short and too close to the
blood vessels of the intestine and stomach to prevent the microspheres from
being injected into other vessels making it impossible to evaluate these final
objectives. The Company intends to continue the studies with another animal
whose anatomy more closely resembles human anatomy than the anatomy of the
rabbit. The animal to be used will be selected after consultation experts and
the FDA. The Company does not believe that this problem reflects adversely on
the Oncosphere technology in any way but rather on the choice of animals for the
studies.
The four objectives that have been met are (i) evaluation of the
functionality of the system, (ii) evaluation of the ability to deliver of the
microspheres with fluoroscopy (x-ray), (iii) evaluation of the distribution of
microspheres in the liver and other organs, (microsphere deposition patterns,
cluster analyses, and location of implantation in liver tissue), and (iv)
evaluation of the ability to image the microspheres post-delivery. Management
believes that by fulfilling these four objectives, the Company has successfully
demonstrated the capability of the Oncosphere to be delivered to the target
area, to be imaged in the liver, and subsequently analyzed for post-planning
purposes.
The two remaining objectives are (a) evaluation of the bioavailability
of free and/or bound Y-90 and In-111 (radiation) in the first 30 days in body
fluids, and (b) evaluation of the effects of the microspheres and radiation on
the liver, adjacent tissues, and possible target organs in the first 90 days.
Studies to achieve those two objectives are now planned to be completed with a
different animal with an anatomy of the liver vasculature (blood vessels) that
more closely reflects the human anatomy than the rabbit, and with an open
surgical procedure, not previously used, to ensure direct placement of the
Oncosphere in the liver vasculature.
These changes are expected to require an additional $1,200,000 in
overall funding over amounts previously estimated and to extend the time for
completion of the animal studies by approximately six months. This additional
funding also includes the costs to allow European commercialization.
Our ability to complete the animal studies, the application European
qualification, or meet any other contingency, is dependent on our ability, which
is uncertain, to raise additional funds from the proceeds of new loans or the
sale of additional equity. As with any development stage medical device product,
there can be no guarantee that even with sufficient funds the product design
will be successful or that the FDA will ultimately provide approval for its
clinical or commercial use.
In addition to the above-described changes in the conduct of animal
studies, we now intend to apply for ISO certification and CE Mark that, if
granted, would permit commercialization of the Oncosphere in the European Union
in 2008. European requirements for necessary approval differ from those in the
United States and may be less expensive and time consuming.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant caused this report to be signed on its behalf by the undersigned
thereunto duly authorized.
Dated: November 26, 2007 ONCOLOGIX TECH INC.
By: /s/ Andrew M. Green
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Andrew M. Green,
Chief Executive Officer
and President
By: /s/ Michael A. Kramarz
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Michael A. Kramarz,
Chief Financial Officer