CyDex Pharmaceuticals Presents Phase 2 Clinical Trial Results for Captisol-Enabled(R) Budesonide/Azelastine Combination Solution

CyDex
Pharmaceuticals, Inc. today announced the presentation of Phase 2
clinical trial results of its novel, proprietary Captisol-Enabled(R)
budesonide/azelastine nasal spray (CDX-313) for seasonal allergic
rhinitis (SAR). The budesonide/azelastine combination nasal spray
demonstrated statistically significant improved results over a nasal
spray placebo.

A randomized, double-blind, placebo-controlled, three-way cross-over
study was conducted in 108 SAR patients to compare the relative efficacy
of Captisol-Enabled Budesonide + Azelastine Nasal Spray (Single
Solution) and Rhinocort Aqua(R)/ (Suspension) + Astelin(R)
Nasal Spray (Solution) against a placebo nasal spray solution in the
treatment of allergic rhinitis in an environmental exposure chamber.

Relief of all nasal symptoms as measured by the Total Nasal Symptom
Score (TNSS) was significantly greater than placebo from 20 minutes
following administration until the session end (10 hours) for both Captisol-Enabled
budesonide/azelastine and Rhinocort Aqua/Astelin (p<0.0001). Onset
of action of relief from itchy nose and sneezing were significantly
faster at 10 minutes for Captisol-Enabled budesonide/azelastine
compared to Rhinocort Aqua/Astelin.

Relief of all eye symptoms as measured by the Total Ocular Symptom Score
(TOSS) was significantly greater than placebo from 40 minutes following
administration until the session end (10 hours) for both Captisol-Enabled
budesonide/azelastine and Rhinocort Aqua/Astelin (p<0.0001). Captisol-Enabled
budesonide/azelastine provided the same or greater numerical TOSS
relief than Rhinocort Aqua/Astelin and longer-lasting relief of
red/burning eyes and itchy eyes.

Theron Odlaug, Ph.D., President and CEO of CyDex, commented, "Our
ongoing research and development progress at CyDex, as demonstrated by
this Phase 2 clinical trial, will continue to propel us forward as we
grow to become a formidable specialty pharmaceutical company. The Captisol-Enabled
budesonide/azelastine nasal spray product is one we intend to license to
a commercial partner. Our ongoing strategy involves development of
products to license as well as products we intend to retain, develop and
commercialize within CyDex Pharmaceuticals."

About Captisol-Enabled Budesonide/Azelastine Nasal Spray

Captisol-Enabled Budesonide/Azelastine Nasal Spray is being
studied as a novel combination of two drugs used to treat seasonal
allergic rhinitis: budesonide and azelastine. Budesonide has been used
clinically for more than 20 years. Azelastine is an antihistamine
currently marketed as Astelin(R) nasal spray. Captisol(R),
CyDex's patented sulfobutyl ether B-cyclodextrin, enables the
combination of the two drugs in an aqueous solution. CyDex has
previously shown that Captisol-Enabled Budesonide provided more
non-nasal symptom relief than the currently marketed product. The safety
data generated to date has shown Captisol-Enabled
Budesonide/Azelastine Nasal Spray to be well tolerated with no
significant adverse events. CyDex is planning a Phase 3 clinical trial
with a development and commercialization partner.

About CyDex Pharmaceuticals

CyDex
Pharmaceuticals, Inc. is a specialty pharmaceutical company
developing products and licensing its Captisol(R)
technology. CyDex is developing its own pipeline of products using its
enabling technology solutions and partnering with leading
pharmaceutical, specialty pharmaceutical and biotechnology companies.
The company maintains patents in the U.S. and worldwide for its Captisol
and cyclodextrin technologies, and a comprehensive FDA drug master file
for client use. For additional information on business development
opportunities, please contact Ralph Johnston at rjohnston@cydexpharma.com
or 913.685.8850. CyDex is a privately held company located in suburban
Kansas City. To learn more about the company, please visit www.cydexpharma.com.

Rhinocort Aqua is a registered trademark of AstraZeneca.

Astelin is a registered trademark of Meda Pharmaceuticals.

SOURCE: CyDex Pharmaceuticals, Inc.

CyDex Pharmaceuticals, Inc. 
Allen K. Roberson, 913-685-8850 
Chief Financial Officer 
aroberson@cydexpharma.com

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