DOR BioPharma Announces Issuance of European Patent for its LPM(TM) Oral Drug Delivery Technology

DOR BioPharma, Inc. (OTC Bulletin Board: DORB) (DOR or the Company), a late-stage biopharmaceutical company, announced today that it has received a European patent which addresses its Lipid Polymer Micelle (LPM(TM)) technology for the improved oral delivery of drugs. The issued European patent, EP 1460992, entitled “Stabilized Reverse Micelle Compositions and Uses Thereof” covers lipid structures (reverse micelles) that promote the intestinal absorption of peptides and other sensitive drugs that cannot otherwise be given orally.

 

“The issuance of the European patent for LPM(TM) demonstrates the novelty of this drug delivery system and the preclinical results clearly show that it is a competitive system for oral delivery of drugs, especially those biotechnology products derived from synthetic peptide chemistry or recombinant DNA,” said Christopher J. Schaber, PhD, DOR President and CEO. “We also believe that the LPM(TM) system will be applicable to a large number of water-soluble drugs including peptides that are poorly permeable, resulting in increased patient compliance and safety.”

 

About the LPM(TM) Technology

 

The LPM(TM) technology is a platform technology that uses reverse micelles stabilized by polymers. Reverse micelles are generally described as a lipid system and are similar to water-in-oil emulsions in that the hydrophilic lipid head groups are directed towards the micelle core, with the hydrophobic tails imbedded in the oil phase. This results in a drug- delivery system that is a thermodynamically stable clear dispersion of the water-soluble drug in the lipid phase. But unlike water-in-oil systems, stabilized reverse micelles do not depend on the presence of other surfactants and are thermodynamically stable. In the LPM(TM) system, water-soluble drugs are contained in the water space in the core of the micelles and are protected against degradation.

 

DOR anticipates proceeding towards clinical development of an oral form of the peptide hormone drug leuprolide using the LPM(TM) technology. Leuprolide is a synthetic peptide agonist of gonadotropin releasing hormone (GnRh) that is used in treatment of endometriosis in women and prostate cancer in men. In preclinical studies in rats and dogs, DOR has demonstrated that the LPM(TM) technology results in high systemic bioavailability of intestinally absorbed leuprolide. In both animal models, the bioavailability of leuprolide ranged from 20 to 40 percent, compared to 2.2 percent for the control oral solution. Leuprolide is one of the most widely used anti-cancer agents for advanced prostate cancer in men. Injectable forms of leuprolide marketed under tradenames such as Lupron(R) and Eligard(R) had worldwide sales of approximately $1.8 billion in 2006. Injectable leuprolide is also widely used in non-cancer indications, such as endometriosis in women (a common condition in which cells normally found in the uterus become implanted in other areas of the body), uterine fibroids in women (noncancerous growths in the uterus) and central precocious puberty in children (a condition causing children to enter puberty too soon). Leuprolide is currently available only in injectable, injectable depot and subcutaneous implant routes of delivery.

 

LPM(TM) is thought to promote intestinal absorption through the action of the micelles to open up small channels that allow only molecules of a certain dimension to pass through, excluding extremely large molecules, bacteria and viruses. The reverse micelles also structurally prevent the rapid inactivation of peptides by enzymes in the upper gastrointestinal tract. Other sensitive drugs that can be delivered orally with the LPM(TM) system include various classes of drugs such as peptides, nucleic acids and proteins which are degraded in the stomach and small intestine. Corresponding patents in the United States and elsewhere are currently pending.

 

About DOR BioPharma, Inc.

DOR BioPharma, Inc. (DOR) is a late-stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. DOR’s lead product, orBec(R) (oral beclomethasone dipropionate or BDP), is a potent, locally acting corticosteroid being developed for the treatment of GI GVHD, a common and potentially life-threatening complication of hematopoietic cell transplantation. DOR expects to begin a confirmatory Phase 3 clinical trial of orBec(R) for the treatment of acute GI GVHD and a Phase 1/2 clinical trial of DOR201 in radiation enteritis in the second half of 2009. orBec(R) is also currently the subject of an NIH-supported, Phase 2, randomized, double-blind, placebo-controlled trial in the prevention of acute GVHD. Oral BDP may also have application in treating other gastrointestinal disorders characterized by severe inflammation. Additionally, DOR has a Lipid Polymer Micelle (LPM(TM)) drug delivery technology for the oral delivery of leuprolide for the treatment of prostate cancer and endometriosis.

 

Through its Biodefense Division, DOR is developing biomedical countermeasures pursuant to the Project BioShield Act of 2004. DOR’s biodefense products in development are recombinant subunit vaccines designed to protect against the lethal effects of exposure to ricin toxin, botulinum toxin and anthrax. DOR’s ricin toxin vaccine, RiVax(TM), has been shown to be well tolerated and immunogenic in a Phase 1 clinical trial in normal volunteers.

 

For further information regarding DOR BioPharma, Inc., please visit the Company’s website at www.dorbiopharma.com.

avVaa World Health Care Products, Inc. Announces That Its DRTV Commercial for Neuroskin(R) Psoriasis Relief Is In Final Stages Of Completion

avVaa World Health Care Products Inc. (Pink Sheets: AVVH), a global biotechnology company, manufacturer and distributor of nationally branded therapeutic, natural skin and health care products, announced today that avVaa is in the final stages for completion of the Neuroskin(R) Psoriasis Relief Direct Response Television (“DRTV”) commercial.

The Neuroskin(R) Psoriasis Relief will have two cuts of the 120 second DRTV commercial with separate call to actions and toll free numbers. The reasons for two separate DRTV CTA and separate toll free number is that the media test will tell avVaa, what time is best to run the spots, what stations are working the best, what geographical areas is the Company selling into, and most importantly for avVaa, which call to action offer works best, and whether their offer was strong enough on behalf of the product and company.

Ms Farley, President/COO/Co Founder stated, “it is important to understand that doing a media test will tell us about our ROI (Return on Investment) and MER (Media Efficiency Ratio). avVaa may need to do two media tests before going into full launch. The media test month is targeted for August as August is Psoriasis Month.”

Ms Farley goes on to say, “we will be donating a certain dollar value from the sales of the DRTV commercial on the Neuroskin(R) Psoriasis Relief by avVaa to a non profit organization which is the country’s largest organization dedicated to psoriasis research and information. Our target market is the 7.5 million Americans, that’s two out of every 100 Americans that have a form of psoriasis, which there is currently no cure for.

The media test month of August should prove that the DRTV commercials were successful and avVaa World Health Care will then plan for a successful full national launch campaign.

 

About avVaa World Health Care Products

 

avVaa World Health Care Products is a global biotechnology company that specializes in effective, all natural, therapeutic skin care products that improve quality of life and well being for consumers. avVaa’s patented European skin care formulas are scientifically registered, FDA-Compliant, and were developed to relieve and treat the symptoms of common skin ailments, including eczema, psoriasis and acne. avVaa is poised to manufacture and market its OTC Neuroskin(r) line of skin care products through mass, food and drug channels in the United States and globally. The Company’s secondary line of equine and pet care related products are already being distributed throughout all of Canada. For more information, visit: www.avvaa.com.

Helicos BioSciences Announces Publication in Nature Biotechnology

Helicos BioSciences Corporation (NASDAQ: HLCS), a life science company focused on innovative genetic analysis technologies, today announced the publication of a landmark study in which single molecule sequencing was used to provide a digital expression profile of a eukaryotic transcriptome. The research article, now appearing in the on-line edition of Nature Biotechnology, demonstrates the unparalleled accuracy, precision and sensitivity of the Helicos™ Digital Gene Expression (DGE) application combined with the power of the Helicos™ Genetic Analysis System. The article will appear in the July 8, 2009 print issue of Nature Biotechnology.

The study consists of a high throughput, amplification-free and ligation-free approach to the accurate quantification of the yeast expressed genome using as few as one of the fifty channels of the HeliScope™ Single Molecule Sequencer.

“Scientists have long sought a simple and quantitative solution for globally interrogating the transcriptome,” said Patrice Milos, PhD, the company’s Chief Scientific Officer. “The data generated using Helicos DGE in our publication in Nature Biotechnology demonstrates an important solution.”

Unlike other technologies that require complex sample preparation, which can drastically skew expression profiling results, the Helicos Genetic Analysis System provides the most direct view of a biological sample available today. Scientists at Helicos utilized the cellular, polyadenylated RNA from a simple cellular system, Saccharomyces cerevisiae, generated only first strand complementary DNA (cDNA) from that RNA, and, in a single step, modified the cDNA for analysis on the Helicos platform. Obtaining on average 12 million aligned reads per HeliScope channel, robust, accurate and highly reproducible measurements enabled a deep view of the yeast transcriptome. Further, sequence data provided information on unique transcripts, alternative transcription start sites and sequence variants present in these genomic samples.

“This publication represents another validation of Helicos’s True Single Molecule Sequencing (tSMS) TM approach for providing our customers with unbiased genetic analysis tools to accurately study normal and disease biology,” said Steve Lombardi, President of Helicos.

The company has also made DGE data sets available from human liver and brain samples on the HeliSphereTM Technology Center (http://open.helicosbio.com/), their open access Web site for sharing Helicos data sets and bioinformatics software tools.

About Helicos BioSciences:

Helicos BioSciences is a life science company focused on innovative genetic analysis technologies for the research, drug discovery, and diagnostic markets. Helicos’ proprietary True Single Molecule Sequencing, tSMS(TM), technology allows direct measurement of billions of strands of DNA enabling scientists to perform experiments and ask questions never before possible. Helicos is a recipient of the $1,000 genome grant and committed to providing scientists the tools to unlock the era of genomic medicine. The company’s corporate headquarters are located at One Kendall Square, Building 700, Cambridge, MA 02139, and its telephone number is  (617) 264-1800 . For more information, please visit www.helicosbio.com