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June 22, 2009, San Diego, CA
Phage Biotechnology Receives Authorization from the U.S. FDA to Initiate Clinical Trial for Dermal Wound Healing

Phage has received permission from the U.S. FDA to begin its Phase I clinical trial for the medical indication of dermal wound healing. The Phase I clinical trial will examine the safety and bioavailability of topical formulations of human Fibroblast Growth Factor-1 (FGF-1) when applied to experimentally induced wounds in normal volunteers. This first clinical trial should be completed in approximately 2-3 months and will be followed with an expanded Phase Ib study where normal volunteers will receive multiple doses of FGF-1.

The first medical indication Phage will seek for FGF-1 is the closure of diabetic foot ulcers. These wounds are a significant healthcare problem in the United States, affecting approximately 20 million patients with diabetes. As FGF-1 stimulates both the growth of new blood vessels (angiogenesis), as well as the growth of new dermal fibroblasts, this protein is an ideal candidate to combat the impaired wound healing often seen in diabetic patients. As part of its authorization to begin this clinical trial, the FDA performed an in-depth analysis of the Phage manufacturing process and its associated procedures.

May 19, 2009, San Diego, CA
Phage Biotechnology Announces Submission of Investigational New Drug (IND) Application to the U.S. FDA for Dermal Wound Healing

Phage compiled and submitted a 500 page IND application to the U.S. FDA to kick off its drug development program in dermal wound healing. The Phase 1a clinical trial will primarily look at safety and bioavailability of topical formulations of human fibroblast growth factor-1 (FGF-1) when applied to experimentally induced wounds in normal volunteers. The small, single dose study (8 patients) should be completed in approximately 2-3 months and will pave the way for an expanded Phase Ib study where normal volunteers will receive multiple doses of FGF-1.

The first medical indication Phage will seek is the closure of diabetic foot ulcers. These wounds are a significant healthcare problem in the United States, ultimately affecting 10-15% of the approximately 20 million patients with diabetes. Dermal leg and foot ulcers arise from a wound healing deficiency seen in diabetics often caused by poor blood perfusion to the legs and feet of these patients. This inadequate blood supply can lead to amputation unless additional blood perfusion can be provided. FGF-1 offers the possibility of improved microvascular perfusion by promotion of blood vessel growth (angiogenesis) in the wound bed resulting in enhanced development of new dermal tissue and accelerated healing.

March 2, 2009, San Diego, CA
Phage Biotechnology gives update on status of its relationship to GHL and CPI

Because the Company has been contacted several times by investors asking about the status of a) their investments held via GHL, and b) their investment in “Cardio-Phage-International” (CPI), Phage herewith gives an update and report of the status.

February 18, 2009, San Diego, CA
Phage Biotechnology Acquires a Quality Control Laboratory Adjacent to its San Diego Manufacturing Facility

Phage has signed a lease for additional space which will be converted into a new Quality Control (QC) laboratory, as well as housing administrative offices. The new space is adjacent to the cGMP manufacturing facility in San Diego, and the QC lab will perform biological and chemical release testing on the protein products which Phage manufactures. The space will be occupied on March 1, 2009, and should be operational within 1-2 months.

February 16, 2009, San Diego, CA
Phage Biotechnology Announces it Will Review Contract Manufacturing Opportunities for Therapeutic Phage Particles

In response to a growing demand to treat medical disorders with live bacteriophage particles, Phage Biotechnology announced it will begin to review the many requests it has received to make phage particles to treat such disorders as cancer, Alzheimer’s Disease, and drug-resistant bacterial infections. Companies that have developed these novel phage therapies have found it difficult, if not impossible, to find a cGMP manufacturer who could produce the new therapies. Phage Biotechnology, to our knowledge, is the only licensed cGMP facility that uses bacteriophages in its manufacturing process, and could readily provide cGMP-quality bacteriophages to these companies on a contract basis. Interested parties should contact either Dr. Wei Chen at 858-427-9140 or Dr. Jack Jacobs at 858-427-9101.

January 6, 2009, San Diego, CA
President’s Letter to Phage Investors

As the new CEO & President of Phage Biotechnology Corporation I would like to take the opportunity of the commencement of the New Year 2009 to personally update you on the most recent news of the company.

November 1, 2008, San Diego, CA
Phage’s San Diego Manufacturing Facility Received Renewal of its California State License

The Food and Drug Branch of the Department of Public Health of the State of California granted Phage the renewal of its license to manufacture pharmaceuticals for clinical and commercial use until August 2010. The plant has produced all of the FGF-1 that CardioVascular BioTherapeutics, Inc. has utilized in its pre-clinical and clinical development programs.

October 28, 2008, San Diego, CA
Phage Enters Chapter 11 Bankruptcy

Phage Biotechnology Corporation (Phage) had an involuntary petition under the United States Bankruptcy Code for Chapter 7 filed against it October 2, 2008 by a group of petitioning creditors in the US Bankruptcy Court for the Southern District of California. After change of management (Mr. Dan Montano and Mr. Grant Gordon stepped down from all their duties at Phage), the new management of Phage filed on October 27, 2008 to convert the Chapter 7 petition to reorganization under Chapter 11. The Court approved the conversion to Chapter 11 on October 28, 2008. Phage is continuing its ordinary course of business and is working through the court system process to reorganize its affairs under Chapter 11. Business is expected to continue uninterrupted at present.

For more information regarding the Bankruptcy, please follow the link to the Chapter 11 - Info page.

November 16, 2007, Las Vegas, NV
Phage Engages The Bruckner Group To Find A Partner to Jointly Commercialize its Portfolio of Recombinant Protein Biopharmaceuticals, Technologies, and Development Platforms

Phage Biotechnology Corporation has engaged The Bruckner Group to find a partner to jointly commercialize its portfolio of recombinant biological therapies, the products of Phage’s development platforms and technologies. 

November 1, 2007, Las Vegas, NV
Phage’s New San Diego Manufacturing Facility Receives California State License

The California Food and Drug Board granted Phage a license to manufacture pharmaceuticals for clinical and commercial use. The plant has produced all of the FGF-1 that CardioVascular BioTherapeutics, Inc. has utilized in its pre-clinical and clinical development programs.

November 14, 2006, San Diego, CA
Phage Completes Pre-clinical Efficacy Study on PEG-Syntropin™, Its Long-Acting Human Growth Hormone Product
 

A 2 month efficacy study in growth-hormone deficient rats indicated that Phage’s long-acting growth hormone product, PEG-Syntropin™, injected once a week, was more potent than daily injections of native growth hormone. Additional efficacy studies in this classical weight gain bioassay for human growth hormone determined the optimal dose of PEG-Syntropin™. Toxicity studies are now underway to support initial human testing of this product, anticipated to start in the second quarter of 2007.  

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