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Recent News and Articles on the Keywords: topical anti-infective + diabetic foot + pexiganan  Related to the article below (Last Update: 5/12/2008)

MacroChem acquires Virium Pharmaceuticals
News-Medical.net, Australia - Apr 23, 2008
We recently acquired exclusive worldwide license rights to pexiganan, a novel topical anti-infective for the treatment of diabetic foot infection, ...OTC:MACM
Source: Google News

Microbiological profile of infected diabetic foot ulcers -
YGD MacDonald, H Hait, B Lipsky, M Zasloff, K … - Diabetic Medicine, 2002 - Blackwell Synergy
... enrolled in two phase-III clinical trials of Pexiganan (a topical peptide
anti-infective agent) [1], had clinically diagnosed infected diabetic foot ulcers ...

Systematic review of antimicrobial treatments for diabetic foot ulcers -
EA Nelson, SO'Meara, S Golder, J Dalton, D Craig, … - Diabetic Medicine, 2006 - Blackwell Synergy
... Tennvall G, Larsson J. Topical treatment of ... (2007) Clinical management of diabetic
foot infection: diagnostics ... Expert Review of Anti-infective Therapy 5:1, 117. ...

The therapeutic potential of antimicrobial peptides from frog skin. -
JM Conlon - Reviews in Medical Microbiology, 2004 - revmedmicrobiol.com
... a topical anti-infective agent for the treatment of infected foot ulcers in diabetic
patients and as a possible treatment for impetigo [50]. Pexiganan showed ...

Antimicrobial and host-defense peptides as new anti-infective therapeutic strategies -
REW Hancock, HG Sahl - Nature Biotechnology, 2006 - nature.com
... of the hallmarks of successful anti-infective therapies, namely ... that are used in
the topical treatment of ... administered to sufferers of diabetic foot ulcer, was ...

Antibiotic Therapy of Infected Diabetic Foot Ulcers.
BA LIPSKY - Abstr Intersci Conf Antimicrob Agents Chemother Intersci …, 1999 - gateway.nlm.nih.gov
... Thus, topical antibiotic therapy may be an ... Keywords: Anti-Bacterial Agents;
Anti-Infective Agents; Antimicrobial Cationic Peptides; Diabetic Foot; Humans; ...

Microbiological profile of infected diabetic foot ulcers
A Options, TOC Latest - Diabetic Medicine, 2002 - ingentaconnect.com
... in two phase-III clinical trials of Pexiganan (a topical peptide anti-infective
agent) [1], had clin- ically diagnosed infected diabetic foot ulcers and were ...
-

Clinical management of diabetic foot infection: diagnostics, therapeutics and the future -
PC Matthews, AR Berendt, BA Lipsky - Expert Review of Anti-Infective Therapy, 2007 - ingentaconnect.com
... of efficacy of anti- biotic agents for treating diabetic foot infection, cost ... and
antibiotics have been used in parenteral, enteral and topical formulations to ...

Antimicrobial peptides in skin disease
JM Schr?der, J Harder - Drug Discovery Today: Therapeutic Strategies, 2006 - Elsevier
... safety profile for patients with infected diabetic foot ulcers ... primarily for topical
use in acne and burn wounds ... Strategy 5: Human AMPs as anti-infective agents. ...

A Review of Antimicrobial Peptides and Their Therapeutic Potential as Anti-Infective Drugs -
YJ Gordon, EG Romanowski, AM McDermott - Current eye research, 2005 - pubmedcentral.nih.gov
... trials involving 835 patients with infected diabetic foot ulcers, both ... with the
administration of topical AMPs as ... clinical toxicity of an anti-infective agent. ...

Advances in the Treatment of Diabetic Foot Infections -
DG Armstrong, BA Lipsky - Diabetes Technology & Therapeutics, 2004 - liebertonline.com
... compared the efficacy of an investigational topical peptide antibiotic, pexi- ganan
acetate, with oral ofloxacin for mildly in- fected diabetic foot ulcers. ...

Source: Google Scholar

Pexiganan, Topical Anti-Infective For Treatment Of Diabetic Foot Infection
MacroChem Corporation (OTCBB: MACM - News) has announced that it has signed an exclusive option to acquire exclusive worldwide license rights for drug uses of pexiganan, a novel, small peptide anti-infective for topical treatment of patients with mild diabetic foot infection (DFI), from Genaera Corporation (Genaera).

"We believe this is a unique opportunity for MacroChem to broaden its product portfolio with a product that has already completed two Phase 3 clinical trials. It also fits our strategic focus and complements our lead product candidate, EcoNail(TM) for treatment of nail fungus currently in a fully enrolled Phase 2 trial and progressing on track with an interim assessment of clinical data later this year after all patients have been treated for twenty four weeks," said Robert J. DeLuccia, President and CEO of MacroChem.
Clinical trials with pexiganan previously conducted by Genaera include two Phase 3 trials submitted in a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in 1998. At that time, outstanding issues with CMC (Chemistry, Manufacturing and Controls) and an FDA request for one additional controlled trial precluded approval.

Mr. DeLuccia further noted, "We would be pleased to have pexiganan in our hands since we believe that, if approved, it would be welcomed by physicians and patients for the treatment of diabetic foot infection. In recent years, there have been many advances in the manufacturing of peptides, a better understanding of the treatment of diabetic foot infection, improvements in clinical trial design and execution, and more clarity concerning regulatory requirements for topical anti-infectives with the potential market being even more attractive than before."

He added, "There continues to be a very large and growing incidence of diabetes and, as a result, a growing number of diabetic foot infections in the U.S. Diabetic foot ulcers in the approximately 20 million diabetics in the US alone are a major concern and burden to both patients and healthcare system. There is also a lack of effective topical anti-infectives to treat diabetic foot infection. Accordingly, we believe that pexiganan could fill an important unmet medical need for a topical anti-infective treatment and provide a significant commercial opportunity in an addressable market of approximately 3.5 million diabetic foot infections annually."

The option agreement gives MacroChem a 90-day exclusive right to enter into a license agreement with Genaera. MacroChem paid Genaera $250,000 on execution of the option agreement.

Both EcoNail and pexiganan would be developed to treat diseases of the foot predominantly treated by the same prescribing specialists, namely podiatrists. Both products would potentially be of interest to a larger number of physician specialists and primary care physicians as well. EcoNail is the company's patented lacquer which contains the antifungal econazole and MacroChem's enhancer SEPA®. Patients participating in the EcoNail study will receive 48 weeks of treatment and will undergo efficacy assessments using standard criteria of nail appearance and mycology. However, the Company will collect and evaluate 24-week interim data later this year. This trial was specifically designed, with the assistance of well-known onychomycosis experts, to address three important objectives: to assess early signs of efficacy, to maintain robust clinical endpoints in the full study, and, if successful, to facilitate advancement to Phase 3 as soon as possible.
About MacroChem

MacroChem Corporation is a specialty pharmaceutical company with two clinical development stage products containing our proprietary enhancer, SEPA®: EcoNail, to treat fungal infection of the nail and Opterone®, to treat male hypogonadism. In addition to our SEPA technology, we are also evaluating applications for MacroDerm(TM), our patented series of polymers that impede penetration of active ingredients through the skin. For more information visit our website, http://www.macrochem.com/.

Forward-Looking Statements

With the exception of historical information contained in this press release, the matters described herein are forward-looking statements that involve risks and uncertainties. MacroChem's actual results may differ significantly from the results discussed in the forward-looking statements. Factors that might cause such a difference include, but are not limited to, those discussed or referred to in the section entitled "Risk Factors" in MacroChem's Annual Report on Form 10-K, as well as those discussed elsewhere therein, and include, without limitation, risks regarding product development, the timing and results of clinical trials, the regulatory approval process, capital requirements, financial condition, patent protection and dependence on third parties for development and licensing arrangements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. MacroChem undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. For more information visit our website, http://www.macrochem.com/.

Source: Bill Douglass
MacroChem
 
 
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