Dec. 15, 2011 10:00 AM Eastern Daylight Time
Avanti Therapeutics Inc. Completes Proof of Concept studies for
Novel Progesterone Formulation for Traumatic Brain Injury
Germantown, Maryland.--Avanti Therapeutics, Inc. (AT-GC) today reported finalizing its
proprietary NanoBindi based formulation of progesterone (AT-PGS-371) for the treatment of
Traumatic Brain Injury. Existing progesterone formulations for Traumatic Brain Injury (TBI) are
not suitable for commercial development because they are imprecisely formulated at the bedside,
resulting in potential variations in drug dosing and the failure to meet strict release specifications
required by regulatory authorities. In addition these formulations lack intellectual property
protection and contain components that are not suitable for long-term infusion.
AT-PGS-371 was developed to obviate these deficiencies and generate a progesterone based
neuroprotection product suitable for approval and that would justify the requisite development
investment. AT-PGS-371 comes in a lyophilized format that can easily be reconstituted at the
hospital bedside or by the emergency medic at accident site to meet strict QC specifications. The
proprietary formulation contains FDA-approved excipients that are suitable for extended bolus
and prolonged infusion.
Today’s announced completion of a 24 month stability study concludes a three year development
project and establishes a two year shelf life for AT-PGS-371 and clearly shows that the
NanoBindi based formulation can be easily reconstituted to meet the product release
specifications. These data satisfy the clinical requirements for a commercially viable
progesterone formulation product.
Arkesh Mehta, Avanti’s CEO, stated, “We believe AT-PGS-371 will enable the transition of
progesterone from a research tool to a commercially viable product. The lack of patent protection
and an approvable formulation have impeded the development of progesterone therapeutics for
TBI. Dr. Mehta, further added, “The current study clearly establishes the capability for the
multifunctional nanoparticle based progesterone to be easily reconstituted and to meet key
stringent release specifications.
Multi-functional NanoBindi based product manufacturing offers a number of compelling
benefits, including flexible modular product design and reduced development cost and time.
While production and regulatory processes for biological products are often complex and time
consuming, Avanti's NanoBindi based products can be developed and approved faster for the
following reasons:


Simple and easily scalable technology enables design variations that are analogous to
structure–activity relation analyses used in small molecule research.
Modular, biodegradable and biologically safe building blocks enable robust and rapid
product development.

Demonstrated scalability is based upon use of established biopharmaceutical unit
operations and processes.
Avanti Therapeutics is now seeking development partners for AT-PGS-371 to pursue an
accelerated 505(b) (2) NDA registration and commercialization strategy for specific neurological
indications including TBI, stroke and spinal cord injury. For more information on Avanti
Therapeutics’ patient-friendly CNS products please visit www.AT-GC.com.
Contacts
Avanti Therapeutics, Inc.
Jenny Smith, 202-677-5458
[email protected]