Genetic Immunity Receives GMP Certification for In-House Manufacturing Facility
BUDAPEST, HUNGARY-- Genetic Immunity ( OTCBB : PWRV ) is pleased to announce the GMP approval of its manufacturing facility. The development of the GMP manufacturing process and the facility was financed from a $4 million grant received from the Hungarian Office for Innovation and Technology.
"To establish a GMP manufacturing facility is a major milestone for Genetic Immunity. Initially, it will serve our need to produce high quality ingredients to our nanomedicine products tested in clinical trials. We developed our GMP manufacturing technology and processes to be suitable to upgrade them to a commercial scale. This approval demonstrates the capability of our team to advance our DermaVir HIV-specific immunotherapy to the market, and our new candidate products from the bench to the bedside," said Dr. Julianna Lisziewicz, CEO of Genetic Immunity.
The GMP status is provided for the manufacturing and the validated quality control processes of the Active Pharmaceutical Ingredient of our immunotherapeutic nanomedicine products. Genetic Immunity has a state of the art R&D laboratory that includes a dedicated GMP facility. Due to the platform feature of our plasmid DNA based nanomedicine technology, only the nucleotide sequence of the DNA is specific for the target disease. Consequently, the manufacturing and the quality control process of the lead and all pipeline products is the same. This means that the GMP facility can be used for the manufacturing all products of Genetic Immunity regardless of clinical stage. The common GMP manufacturing technology simplifies the regulatory process, saves costs and time in clinical development, and reduces time to market approval of medicinal products.
"With this GMP facility we have successfully closed the manufacturing gap between clinical trial scale and the commercial production. With continuous development of the manufacturing processes we are able to control the costs and achieve a competitive price for each market segments at an attractive ROI ratio for every product. We are strongly focused on the market and are well prepared for large scale manufacturing for our planned Expanded Access program of DermaVir," said Mr. Viktor Rozsnyay, CEO of Power of the Dream Ventures.
Genetic Immunity is a wholly owned subsidiary of Power of the Dream Ventures, Inc. ( OTCBB : PWRV ).
About Genetic Immunity
Genetic Immunity is part of Power of the Dream Ventures, Inc. (PWRV) committed to bring innovative Hungarian products and services to public. Genetic Immunity is a clinical stage technology company committed to discovering, developing, manufacturing and commercializing a new class of immunotherapeutic biologic drugs for the treatment of viral infections, cancer and allergy. The Company's two distinguished technology platforms will revolutionize the treatment of these chronic diseases. Our Langerhans cell targeting nanomedicines are exceptional in both safety and immune modulating activity boosting specific Th1-type central memory T cells. Such immune responses differ from antibodies induced by vaccines. These are essential to eliminate infected cells or cancerous cells, and balance the immune reactivity in response to allergens. Our IT team generated a complex algorithm to match the mechanism of action of our drugs with clinical efficacy. In the future, we will predict the clinical and immunological benefits of our drugs based on the patient's disease and genomic background. The unique mixture of our technologies represents the next generation of personalized but not individualized medicines ensuring a longer and higher economic return. Genetic Immunity's primary focus is the development of DermaVir that acts to boost the immune system of HIV-infected people to eliminate the infected cells that remained in the reservoirs after successful antiretroviral treatment. Three clinical trials conducted in EU and US showed that DermaVir immunizations were as safe as placebo and only four sequential patch treatments were required to reduce the HIV infected cells in the blood within 24 weeks.
In 1988 Drs. Lisziewicz and Lori founded the Genetic Immunity in the US after they described the 1st patient whose immune system was boosted to control HIV after treatment interruption (Lisziewicz et al. New England Journal of Medicine 1999) that lead to the invention of DermaVir. The Company's innovative technology team directed by Dr. Lisziewicz, a champion of immune busting therapies, is now headquartered in Budapest (Hungary). For more information please visit http://www.geneticimmunity.com.
Statements in this press release that are not strictly historical in nature constitute forward-looking statements qualified in their entirety by this cautionary statement. Forward-looking statements include, without limitation, statements regarding business combination and similar transactions, prospective performance and opportunities and the outlook for the companies' businesses, including, without limitation, the ability of PWRV to advance Genetic Immunity's product pipeline or develop a curative immunotherapy for HIV, performance and opportunities and regulatory approvals, the anticipated timing of data from clinical data; the possibility of unfavorable results of the company's clinical trials; filings and approvals relating to the transaction; the expected timing of the completion of the transaction; the ability to complete the transaction considering the various closing conditions; and any assumptions underlying any of the foregoing. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. Actual results may differ materially from those currently anticipated due to a number of risks and uncertainties. All forward-looking statements are based on information currently available to the companies, and the companies assume no obligation to update any such forward-looking statements.
Dr. Zsolt Lisziewicz
Chief Operating Officer
Power of the Dream Ventures
President and CEO