Pacgen Announces Positive Results from Phase I/II Trial of Novel Anti-Fungal Dru

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Pacgen Announces Positive Results from Phase I/II Trial of Novel

Anti-Fungal Drug

PipelineReview.com - Barcelona,Spain

http://www.pipelinereview.com/joomla/content/view/11652/101/

Pacgen Biopharmaceuticals Corporation ( " Pacgen " ) (TSX-V: PGA) is

pleased to report that topline results from its Phase I/II study of

PAC-113, a novel antifungal, show it is generally safe, well-

tolerated, and active in the treatment of oral Candida infection

with clinical cure rates comparable to the current standard of care.

VANCOUVER, Canada | May 7, 2007 | Pacgen Biopharmaceuticals

Corporation ( " Pacgen " ) (TSX-V: PGA) is pleased to report that

topline results from its Phase I/II study of PAC-113, a novel

antifungal, show it is generally safe, well-tolerated, and active in

the treatment of oral Candida infection with clinical cure rates

comparable to the current standard of care. Based on these results

the Company plans to initiate a Phase IIb study to optimize PAC-113

dose and formulation.

" For many immunocompromised patients oral candidiasis can be severe,

impacting their ability to get appropriate nutrition. We are very

encouraged by the PAC-113 results and its potential to help patients

with oral candidiasis, particularly when available treatments have a

number of limitations and drawbacks, " said Dr. Neil Reiner,

Professor and Head of Division of Infectious Diseases, UBC

Department of Medicine and Vancouver General Hospital, and a member

of Pacgen's Clinical Advisory Board

PAC-113 is a peptide based anti-fungal drug candidate targeting oral

Candida infections in immunocompromised patients and patients with

salivary dysfunction. The Phase I/II clinical trial of PAC-113 was

conducted at sites in the United States and South Africa and

recruited over 100 HIV seropositive patients with oral candidiasis.

The objective of this study was to provide safety data for PAC-113,

as well as to establish first proof of efficacy for PAC-113 in

eliminating clinical signs and symptoms of oral candidiasis. This

Phase I/II study was a comparison between PAC-113 mouthrinse and

Nystatin oral suspension. The study was a randomized, examiner-

blinded, parallel design clinical trial that included a 14-day

treatment phase, and a 14-day follow-up period, with a day 28 follow-

up visit. Analyses were conducted on patients who were at least 80%

compliant in the treatment phase.

Topline results show that 37% of PAC-113 patients were assessed as

clinically cured at day 14 compared to 36% of Nystatin patients.

Complete or partial responses at day 14 were observed in 95% of PAC-

113 patients and 87% of Nystatin patients in the same population.

Results also confirm that PAC-113 was generally safe and well-

tolerated.

" We are very encouraged with these clinical results and expect that

optimization of PAC-113 dose and formulation, as planned in the next

Phase II trial, will further enhance clinical efficacy. We believe

that these efforts in conjunction with the product's competitive

advantages over existing treatments for oral candidiasis make it an

excellent drug candidate to take into late stage studies, " said

Duffy DuFresne, President & CEO of Pacgen.

About PAC-113

PAC-113 is a 12 amino-acid antimicrobial peptide derived from a

naturally occurring histatin protein found in saliva. This peptide

alters the permeability of fungal cell membranes causing cell death.

In addition, PAC-113 also interacts with fungal mitochondria causing

production of reactive oxygen species that lead to fungal cell

destruction. This activity is unique to histatin proteins.

Current treatments for Candida infections are not effective in

eliminating the infection, can have serious side effects, have

significant potential for drug interaction, and/or do not prevent

the development of drug-resistant fungal infection. PAC-113 is

easily administered and well-tolerated by patients as it is

formulated as a sugar-free, pleasant tasting, non-viscous mouthrinse

with a neutral pH. It also has a prolonged half-life in the saliva

giving it the potential to extend the duration of the therapeutic

effect, increasing the cure rate and reducing the time to relapse.

About Candida Infection

Candida albicans is the most common fungal pathogen among immune-

compromised, hospitalized patients, accounting for roughly 50-60% of

all bloodstream fungal isolates. Opportunistic growth of Candida can

be life-threatening if not treated.

Oropharyngeal candidiasis, also referred to as " thrush " , is a local

infection seen in patients treated with antibiotics or steroids,

chemotherapy, or radiation therapy to the head and neck, and those

with cellular immune deficiency states, such as HIV and AIDS.

Patients with xerostomia and those treated with inhaled

corticosteroids for asthma or rhinitis are also at risk.

Oropharyngeal candidiasis infection can cause great discomfort, and

if not treated, can spread from the primary site of infection

through the blood stream to cause a disseminated infection.

Disseminated fungal infections are associated with a high mortality

rate.

The demand for effective anti-fungals is driven by a rising

incidence of immunocompromised patients populations including

individuals with HIV, cancer, asthma and diabetes, among others. In

2004, global sales of topical anti-fungal drugs represented nearly a

US $1.6 billion dollar market, and it is projected to grow to US

$2.1 billion by 2009. Pacgen estimates that the current worldwide

market opportunity for a novel, safe and effective, oral candidiasis

therapy is approximately US $300 million.

About Pacgen

Pacgen is a life sciences company focused on the development of

therapeutics for the treatment of infectious and inflammatory

diseases. The Company's lead product, PAC-113, is an anti-fungal in

a Phase II clinical program. Pacgen also has candidates in an early

stage research program. The most advanced of these candidates is a

protein therapeutic, PAC-G31P, which is currently being investigated

in preclinical studies for its potential to treat inflammatory

diseases such as acute respiratory distress syndrome. For additional

information, please visit www.pacgenbiopharm.com.

NO REGULATORY AUTHORITY HAS APPROVED OR DISAPPROVED THE CONTENT OF

THIS RELEASE. THE TSX VENTURE EXHANGE DOES NOT ACCEPT RESPONSIBILITY

FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

Forward looking Statements

Certain statements included in this press release may be considered

forward-looking. Such statements involve known and unknown risks,

uncertainties and other factors that may cause actual results,

performance or achievements to be materially different from those

implied by such statements, and therefore these statements should

not be read as guarantees of future performance or results. All

forward-looking statements are based on Pacgen's current beliefs as

well as assumptions made by and information currently available to

Pacgen and relate to, among other things, anticipated financial

performance, business prospects, strategies, regulatory

developments, market acceptance and future commitments. Readers are

cautioned not to place undue reliance on these forward looking

statements, which speak only as of the date of this press release.

Due to risks and uncertainties, including the risks and

uncertainties identified by Pacgen in its Final Prospectus dated

November 28, 2006, actual events may differ materially from current

expectations. Pacgen disclaims any intention or obligation to update

or revise any forward-looking statements, whether as a result of new

information, future events or otherwise. For all forward-looking

statements, Pacgen claims the safe harbour for forward-looking

statements within the meaning of the Private Securities Legislation

Reform.

SOURCE: Pacgen Biopharmaceuticals Corporation