fm8k-0908.htm
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 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): September
22, 2008
(Exact
Name of Registrant as Specified in Its Charter)
(State or
Other Jurisdiction of Incorporation)
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000-53404
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87-0652870
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(Commission
File Number)
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(IRS
Employer Identification No.)
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3293
Harrison Blvd., Ste. 230, Ogden, UT
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84403
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(Address
of Principal Executive Offices)
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(Zip
Code)
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(Registrant’s
Telephone Number, Including Area Code)
(Former
Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the
Form 8-K filing is intended to simultaneously satisfy the filing obligation of
the registrant under any of the following provisions (see General Instruction A.2.
below):
¨ 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))
Item 1.01
Entry into a Material Definitive Agreement.
On September 22, 2008, Bio-Path
Holdings, Inc. (the “Registrant”) entered into a Drug Development and Clinical
Supply Agreement (the “Agreement”) with Althea Technologies, Inc. (“Althea”), a
San Diego based leading provider of innovative technologies and services for
pharmaceutical development and manufacturing. Pursuant to the
Agreement, Althea will develop a current Good Manufacturing Practices (“cGMP”)
formulation, fill/finish, and lyophilization of the Registrant’s drug product
BP-100-1.01 for a Phase I Clinical Trial. (Lyophilization or freeze drying is
the process used to manufacture Registrant’s drug product). The deemed effective
date for the agreement is June 24, 2008.
The
scientific name of Registrant’s BP-100-1.01 drug product to be manufactured
under this Agreement is liposomal growth receptor bound protein-2, an antisense
incorporated liposome drug product. BP-100-1.01 is a cancer treatment
drug for patients having the diseases Acute Myeloid Leukemia (AML),
Myelodysplastic Syndrome (MDS) and Chronic Myelogenous Leukemia
(CML).
Item 9.01 Financial
Statements and Exhibits.
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B.
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Exhibits. Item
10.1 - Drug Product Development and Clinical Supply Agreement
(attached)
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SIGNATURES
Pursuant to the requirements of the
Securities Act of 1934, the Registrant has duly caused this report to be signed
on its behalf by the undersigned thereunto duly authorized.
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Dated: October
14, 2008
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BIO-PATH
HOLDINGS, INC.
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By: /s/
Peter Nielsen
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Chief
Executive Officer
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