Word quickly spread about the pharmacy’s service and expertise. In 1998, the decision was made to drop the retail side and focus exclusively on compounding.

Compounding is the answer to health issues for countless patients: some patients may be allergic to ingredients found in mass-produced medications, some need to take more obscure drugs that are no longer manufactured, or may require a specific dose that isn’t commercially available. Others have difficulty with swallowing pills and would welcome a topical or liquid form of their medications. Compounding can meet all of these individual needs, and more.

Rudner always had great hopes for her business. But even she may not have foreseen how Belvidere would blossom over the next decade and a half. The name Belvidere has become synonymous with quality, and its reputation has grown beyond the physicians and patients it served at the outset. As a result, the organization has been commissioned by several pharmaceutical companies for clinical trials.

In 2007, Belvidere became the first PCAB accredited compounding pharmacy in New Jersey; earning it a place of honor on the national compounding stage. It was awarded reaccreditation in 2010.

The pharmacy’s new, ultramodern space will bring a host of conveniences and a serious “cool” factor to its clientele of patients, physicians and veterinarians. It’s considerably larger, with a spacious and comfortable waiting area; has a street-level entrance; and is easily accessible from major roads and several area hospitals. The pharmacy’s new design is contemporary, inviting, and “green,” featuring a seamless, metallic copper epoxy floor, solar panels, paper-free faxes and more.

The most important upgrades are those behind the scenes.

“We’ve always prided ourselves on being on the cutting edge,” said Rudner, “We offer nothing less to our clientele. But this move presented a unique opportunity: To create a facility that significantly exceeds national standards. And we are thrilled to have achieved that.” The Highland Park facility now offers multiple ISO class 7 compounding rooms; new clean rooms; and equipment designed to prepare sterile preparations. It’s all brand new, and eclipses most of Belvidere’s competitors.

“With our new facility, we’re able to accommodate individual customized medications, as well as any scale clinical study,” said Rudner. “Our innovative facility goes hand-in-hand with our extensive policies and procedures.”

According to Rudner, the demand for individualized medications is rapidly on the rise for patients of every species. In addition to formulating medications for people, Belvidere also specializes in compounding veterinary prescriptions. The pharmacy serves practitioners and patients from a wide geographic area and the full spectrum of specialties. Belvidere accepts most insurance plans in order to meet the growing needs of its customers.

With its new facility, a new chapter begins for this important player in a growing sector of modern healthcare.

“We’re very excited to call Highland Park home for Belvidere Pharmacy. It’s a vibrant community,” said Rudner. “We look forward to thriving here for years to come.”

For more information, visit www.BelviderePharmacy.com or www.facebook.com/BelviderePharmacy .

- RSS news feed for Belvidere Pharmacy: http://send2pressnewswire.com/author/belvidere-pharmacy/feed .

News Source: Belvidere Pharmacy :: This press release was issued on behalf of the news source by Send2Press® Newswire, a service of Neotrope®. View all current news at: http://Send2PressNewswire.com .

The paper, “Comprehensive assay of kinase catalytic activity reveals features of kinase inhibitor selectivity,” was the product of a collaboration between RBC and the Fox Chase Cancer Center of Philadelphia. The article is currently available online and will be in the November 2011 print edition of Nature Biotechnology.

The data set from the study can be viewed at reactionbiology.com/webapps/kir/.

To perform the study, the researchers selected 178 small molecule kinase inhibitors, including FDA-approved drugs, clinical trial agents and research compounds. These compounds, known to include inhibitors of all major kinase families, were then systematically profiled against 300 human wild-type kinases, also representing all major kinase families. Quantitative analysis of the results revealed that many well-studied kinase inhibitors had significant and hitherto unknown off-target activities. In other words, not only did they inhibit enzymes belonging to the same subfamilies as their putative targets, but they also inhibited kinases from completely different families. 6 compounds, in particular, had off-target inhibition levels stronger than the intended target. These results emphasize the importance of profiling compounds against a broad kinase panel before proceeding to animal studies or clinical trials.

As part of their analysis of the new data set, the authors introduced the concept of a “uni-specific kinase inhibitor.” A compound with a high “uni-specificity” score is one whose inhibition of one particular kinase greatly exceeds its inhibition of the second most inhibited kinase, a stringent measure of compound selectivity. This approach helped to identify many potential lead compounds for “orphan” kinases, enzymes for which few inhibitors currently exist. In a parallel analysis of the data set, the researchers sought compounds whose primary target was a cancer-relevant kinase, but which could also inhibit a limited number of cancer-relevant kinases outside the primary target’s family. Such an approach can serve as the starting point for developing new multi-targeted kinase inhibitors and therapeutics.

“Kinase drug discovery remains a significant interest for both our academic customers and those in the pharmaceutical industry,” said Haiching Ma, Ph.D., Chief Technology Officer of RBC and one of the lead authors. “In the past decade, a large number of kinase inhibitors have been synthesized and published. However, there is no study trying to understand how these compounds interact with a large panel of kinases, especially using the activity-based assay formats used by majority of the kinase research labs. Applying the low-cost, high-throughput HotSpot platform, RBC has created the most reliable kinome-inhibitor database that a ‘gold standard’ radiometric assay format can produce.”

Dr. Ma continued, “This data set will not only help drug discovery activity in the industry, but also provide guidance for selecting the right tool compounds for use in routine kinase biology studies. RBC’s HotSpot provides a vital tool to evaluate these potential drug candidates.”

To date, RBC has developed and optimized assays for over 400 human kinases, including atypical kinases, mutants and lipid kinases that are important drug targets. “RBC is the market leader in providing activity-based screening and profiling. The panel we have collected has 100 more enzymes than most of our competitors,” said Mr. Matthew Oristano, Chairman of RBC. “With this continually growing panel of kinases, we can offer scientists a better understanding of their compounds and reduce the failure rate in future clinical trials. This publication has clearly demonstrated the value of including kinome-wide profiling as an integral part of compound lead validation.”

About Reaction Biology Corp.:
Based in Malvern, PA, RBC is a premier provider of drug screening and profiling services. With over 400 kinases, RBC’s coverage of the kinome is the broadest in the industry for enzyme activity assays. Using its proprietary HotSpot(SM) technology and other innovations, RBC is also expanding its services to cover a broad range of epigenetic regulatory enzymes, including HDACs, HATs, HMTs, DNMTs, demethylases and epigenetic readers. RBC provides its services to over 200 customers worldwide, including large pharmaceutical, biotech, government and academic labs.

For more information, visit: www.reactionbiology.com.

HotSpot is a service mark of Reaction Biology Corp.

News Source: Reaction Biology Corporation :: This press release was issued on behalf of the news source by Send2Press® Newswire, a service of Neotrope®. View all current news at: http://Send2PressNewswire.com .

The enzymes offered for sale are active and validated for use in high-throughput screening assays. In the case of the HMTs those assays employ RBC’s proprietary HotSpot(SM) methodology, which couples economical screening with the data quality of a “gold standard” radiometric approach. HMTs are also routinely assayed by conventional scintillation counting in a plate format (TopCount).

“Our assay expertise is helping us make better enzymes, while the ability to produce new proteins in-house will help us expand the range of assays we can offer, and provide our clients with a more complete drug discovery process,” said Konrad Howitz, RBC’s Director of Epigenetics.

In addition to the HDAC, Sirtuin, HMT, DNMT and HAT assays currently offered, RBC has innovative assays for demethylases and epigenetic readers in active development.

Based in Malvern, PA, RBC has become a premier provider of drug screening and profiling services. With more than 400 kinases, RBC’s coverage of the kinome is the broadest in the industry. Using its proprietary HotSpot(SM) technology and other innovations, RBC is expanding its already substantial coverage of epigenetic regulatory enzymes. RBC has provided its services to over 200 customers worldwide, including large pharmaceutical, biotech, government, and academic labs.

For more information, visit: www.reactionbiology.com.

News Source: Reaction Biology Corporation :: This press release was issued on behalf of the news source by Send2Press® Newswire, a service of Neotrope®. View all current news at: http://Send2PressNewswire.com .

According to Dr. Maria Gordon, Chief Medical Officer of Epeius, “What this means, in terms of clinical development, is that the Rexin-G product, with its advanced GMP manufacturing, bio-processing, and final formulation, meets rigorous FDA standards for obtaining a marketing license in the future; and that Epeius Biotech can now proceed with its strategic, diversified Phase 3 drug development program for pancreatic cancer, osteosarcoma and soft tissue sarcoma.”

In addition to these high-priority programs, Rexin-G has demonstrated significant anti-tumor activity in chemotherapy-resistant breast cancer, hormone-refractory prostate cancer, ovarian cancer, squamous cell carcinoma, and certain hematologic malignancies, such as large B-cell lymphoma.

Rexin-G® was granted accelerated approval for the treatment of all chemotherapy-resistant solid malignancies in the Republic of the Philippines in 2007. In the U.S.A., Rexin-G gained Orphan Drug Designation and market protections from the FDA for pancreatic cancer in 2003, followed by Orphan Drug Status for both osteosarcoma and soft tissue sarcoma in 2008. More recently, Epeius Biotechnologies completed a series of Phase 1 and Phase 2 clinical trials in the U.S., establishing the thresholds for bioactivity and dose-dependent efficacy for Rexin-G against a number of otherwise intractable cancers, as well as the product’s overall safety over extended survival times and a notable lack of either safety issues or dose-limiting toxicities.

With these development-stage accomplishments at hand, Epeius is gearing up to open a series of pivotal studies for both pancreatic cancer and sarcomas in the U.S., while continuing to advance the clinical utility and market development of Rexin-G worldwide.

With the completion of the enabling platform development and the clinical validation of its foremost oncology product, Epeius Biotechnologies continues to lead the field of genetic medicine with the development of its product pipeline, which includes Reximmune-C, a tumor-targeted gene delivery system for “personalized” cancer vaccinations, administered to stimulate a long-lasting anti-tumor immunity.

For further information about Epeius Biotechnologies, its lead products, and its clinical trials, please contact Erlinda M. Gordon, M.D., at egordon@epeiusbiotech.com .

- RSS news feed for Epeius Bio:

http://send2pressnewswire.com/author/epeius-biotechnologies-corporation/feed

News Source: Epeius Biotechnologies Corporation :: This press release was issued on behalf of the news source by Send2Press® Newswire, a service of Neotrope®. View all current news at: http://Send2PressNewswire.com .

“We are very proud to be reaccredited by PCAB,” said Shara Rudner, R.Ph., FIACP, FACA, FACVP, and president of Belvidere Pharmacy. “This accreditation demonstrates that we meet the highest quality and safety standards in our profession. It takes a daily, concerted effort by my entire staff, and we were thrilled to receive it again.”

Belvidere is exclusively a compounding pharmacy that serves both human and veterinary patients. A compounding pharmacy is one that creates or mixes medications for individual patients, for a variety of medical reasons. Compounded medications are prescriptions written by physicians, veterinarians or other legally authorized prescribers for their patients with special needs that cannot be met by mass-produced drugs.

Examples are many, and include:
- Creating medications for patients with allergies or low-tolerances for certain ingredients-such as gluten and sugar-that are used in mass-manufactured medications.
- Preparing medicines that a physician wants for his or her patient, but has been discontinued by a large pharmaceutical company for economic reasons.
- Mixing a smaller dose of a medication for a child, when that medication is only commercially available in adult doses.
- Crafting specific, but commercially unavailable, doses of medications for both human and animal patients.

Although these situations seem rare, they’re not. In fact, some 30 to 40 million compounded prescriptions are made every year. While many pharmacies practice a small degree of compounding, it is considered a specialty-one that has been an integral part of pharmacy practice for centuries. Compounding is regulated on the state level, but the national PCAB accreditation sets comprehensive and strict standards for pharmacies that earn its respected seal of approval.

That process is demanding, and includes completing an extensive application process, documenting written policies and providing an analysis of quality procedures – all of which are reviewed by PCAB and leaders in the field. Following the paperwork comes an onsite inspection lead by compounding experts. Belvidere completed all requirements for its reaccreditation, granting it the continued right to say that it is a “PCAB accredited™ compounding pharmacy.”

Rudner explained that her pharmacy serves a broad spectrum of practitioners and their patients from a wide geographic area, all of whom rely on her and her staff for these specially made medicines. For Rudner, the PCAB accreditation is her way of guaranteeing her clientele that they’re working with the best in the industry.

“We simply wouldn’t have it any other way,” said Rudner.

Belvidere Pharmacy has served its community since 1959. Shara Rudner – a fellow of the International Academy of Compounding Pharmacists, a fellow and regional director of the American College of Apothecaries, a fellow of the American College of Veterinary Pharmacists and secretary of the New Jersey Academy of Compounding Pharmacists – has been owner and president of Belvidere since 1996. Under her leadership, Belvidere became an exclusive compounding pharmacy more than a decade ago. To learn more about Belvidere Pharmacy visit www.belviderepharmacy.com.

The Pharmacy Compounding Accreditation Board is a not-for-profit corporation formed by eight national pharmacy organizations that recognized the need for a national standards organization for compounding pharmacy. Together, these leading organizations developed the policies and standards for the practice of compounding pharmacy, as well as the PCAB Accreditation criteria and processes. To learn more about PCAB accreditation, visit www.pcab.org.

News Source: Belvidere Pharmacy :: This press release was issued on behalf of the news source by Send2Press® Newswire, a service of Neotrope®.

» Plain text copy of press release (and media contact)
» PDF copy of press release (and media contact)

This latest support for the clinical advancement of Rexin-G comes from the Qualifying Therapeutic Discovery Project (QTDP) program, created as a component of the Patient Protection and Affordable Care Act of 2010 to support projects that are determined by the HSS to have significant potential (i) to develop innovative new treatments to address major unmet medical needs, (ii) to reduce long-term health care costs, (iii) to represent significant medical progress toward an eventual treatment/cure for cancer, (iv) to advance U.S. competitiveness in the fields of life science and medical technologies, and (v) to create and/or sustain well-paying jobs in the United States.

This meritorious tranche of U.S. Government support for Rexin-G, the world’s first and, so far, only targeted injectable genetic medicine for cancer that has been validated in clinical trials, represents the latest formal declaration of the potential importance, competitiveness, and overall merit of the platform of highly-advanced molecular biotechnologies and nanotechnologies embodied in this targeted injectable anticancer agent.

“We are very pleased with this formal recognition and support of our medical mission, for it represents a continuing commitment to develop the high-value products and intellectual properties of this company for the benefit of all,” said Lina Kabayan, Epeius CFO who spearheaded this latest grant submission.

From the first National Science Foundation (NSF) and NIH grants awarded to the founders of Epeius Biotechnologies, to the American Heart Association (AHA) which provided funding to support the cardiovascular targeting technologies, to the Office of Orphan Products Development (OOPD) which provided funding for the first clinical trials in the U.S., and which ultimately granted Orphan Drug Status to Rexin-G for three separate clinical indications (pancreatic cancer, soft tissue sarcoma, and osteosarcoma), to the U.S. FDA which granted Fast Track Status to Rexin-G for chemotherapy-resistant pancreatic cancer, the continuing federal support for these vital medical technologies is a testament that basic science and innovation in the service of medicine is still alive and well in America.

About Epeius Biotechnologies Corporation:
Epeius Biotechnologies Corporation is a privately held biopharmaceutical company that is bringing the latest advancements in genetic medicine to the cancer patient with the development and commercialization of its leading oncology products and its tumor-targeted delivery systems. Rexin-G® is currently approved for the treatment of all chemotherapy-resistant solid tumors by the Philippine FDA.

Learn more about our lead products and/or our pipeline of proprietary biotechnologies at: www.epeiusbiotech.com. For recent papers, expert reviews, clinical reports in oncology and molecular therapy, see the “Publications” section.

- Epeius Biotechnologies news RSS feed:
http://send2pressnewswire.com/author/epeius-biotechnologies-corporation/feed .

News Source: Epeius Biotechnologies Corporation :: This press release was issued on behalf of the news source by Send2Press® Newswire, a service of Neotrope®.

» Plain text copy of press release (and media contact)
» PDF copy of press release (and media contact)

RBC’s HotSpot(SM) technology is an ultra-low volume tritium-based assay platform that provides gold-standard methyltransferase inhibition data.

The technology is offered as a screening service, allowing clients to avoid operational issues related to dealing with radioisotope management, and quickly find productive lead candidates.

RBC Chief Technology Officer Haiching Ma said, “Epigenetic mechanisms are increasingly recognized as fundamental to several cancers and many other diseases. Up until now, there has been no cost-effective way to do large-scale methyltransferase screening and profiling. We hope that RBC’s ability to fill this unmet need will speed the discovery of new drugs in this area.”

Based in Malvern, PA, RBC specializes in providing high quality biochemical enzyme assay data, using ultra-low volumes and proprietary methods. RBC has provided its services to over 190 customers worldwide, including large pharmaceutical, biotech, government, and academic labs.

RBC’s Kinase HotSpot platform is a widely used service for providing high quality low-cost kinase screening data worldwide. The company also provides HDAC, protease, and other screening services, as well as custom assay development and partnerships.

For more information, visit: www.reactionbiology.com .

Plain text copy of press release (and media contact)

PDF copy of press release (and media contact)


STORY REFERENCES: Reaction Biology Receives NCI Grant Award for Epigenetic Platform, Reaction Biology Corporation, RBC Kinase HotSpot, HDAC, protease, and other screening services, epigenetic, methyltransferase, biotech, drug discovery, Haiching Ma, Phase II SBIR grant, National Cancer Institute, pharma

As the development of its lead oncology product advances in the clinic towards regulatory approval, the critical proofs-of-principle, i.e., definitive demonstrations of overall safety and single-agent efficacy in clinical trials, serve as the scientific and innovative basis for attaining additional patent protections in the emerging field of tumor-targeted biologics. Indeed, Epeius Biotechnologies has accumulated more than 150 issued/allowed/granted patents in the area of genetic medicine, including more than 40 pending applications.

Furthermore, the U.S. FDA has recently granted Orphan Drug status to Rexin-G, the company’s lead product, for three separate clinical indications based on formal evaluations of clinical safety and potential efficacy, which provides additional market protections and economic incentives pertaining to such a significant and yet unmet medical need as the treatment of chemotherapy-resistant cancers.

Exhibiting broad-spectrum anti-cancer activity against many otherwise intractable cancers, Rexin-G has demonstrated a number of first-in-class, best-in-class characteristics: (1) The tumor-targeting properties of the gene delivery platform are profound, capable of seeking-out, accumulating-in, and halting-the-progression-of widespread cancers by means of simple intravenous infusions. (2) The broad-spectrum anti-cancer activity is achieved “by design”, as the genetic payload is focused on a critical locus of cellular growth control and tumor suppression. (3) Years of progressive clinical trials have advanced the field by establishing cumulative safety (with no dose-limiting toxicities), practical pharmacological thresholds, quantitative dose-response relationships, and clinical infusion protocols which optimize patient benefits, including significant survival benefits. (4) Equally important are the advancements in biopharmaceutical science that provide for greater purities, potencies, GMP productivity, and economies-of-scale, and which translate into more-affordable treatments for cancer patients. All in all, it seems that Small, Smart, and Stealth may turn out to be a very cool hand to grasp, and to hold on to.

About Epeius Biotechnologies:

Epeius Biotechnologies Corporation is a privately held biopharmaceutical company dedicated to the advancement of genetic medicine with the development and commercialization of its leading oncology products and its tumor-targeted delivery systems. Rexin-G is currently approved for the treatment of all chemotherapy-resistant solid tumors by the Philippine FDA. To learn more about our lead products and/or our pipeline of proprietary biotechnologies, please visit us at http://www.epeiusbiotech.com .

For recent papers, expert reviews, clinical reports in oncology and molecular therapy, etc., see the “Publications” section on our website.

News Source: Epeius Biotechnologies Corporation :: This press release was issued by Send2Press® and is Copyright © 2010 Neotrope® News Network – all rights reserved.

STUDY SUMMARY: The goals of the study were to evaluate the over-all safety and efficacy of intravenous infusions of Rexin-G, a tumor-targeted retrovector bearing a cytocidal anti-cyclin G1 construct, in chemo-therapy-resistant bone and soft tissue sarcoma. A Phase II “run-in” component was integrated by adaptive design by continuing treatment if the patient had Grade 1 or less toxicity. Thirty-six patients received escalating doses of Rexin-G intravenously three times a week for four weeks. Analysis of safety showed no dose-limiting toxicity and no cumulative toxicity in patients treated with Rexin-G monotherapy for up to 2 years. Analysis of efficacy revealed a dose-dependent relationship between progression-free survival/overall survival and Rexin-G dosage (p = 0.02 and 0.002 respectively) which was significant at the 5% statistical level by the log-rank test. Median survival was 11.5 months and one-year survival was 40% in the high-dose groups. These findings indicate that intravenous Rexin-G is safe and well-tolerated with no cumulative toxicity, and that Rexin-G controls tumor growth, and prolongs progression-free survival and over-all survival times in a dose-dependent manner in patients with chemotherapy resistant bone and soft tissue sarcoma.

About Epeius Biotechnologies:

Epeius Biotechnologies Corporation (www.epeiusbiotech.com) is a privately held biopharmaceutical company dedicated to the advancement of genetic medicine with the development and commercialization of its lead products, Rexin-G and Reximmune-C, and its high-performance gene delivery systems.

To learn more about these agents and/or ongoing clinical trials, please contact Dr. Erlinda M. Gordon at egordon_@_epeiusbiotech.com.

News Source: Epeius Biotechnologies Corporation :: This press release was issued by Send2Press® and is Copyright © 2010 Neotrope® News Network – all rights reserved.

SUMMARY: Rexin-G and Reximmune-C are tumor-targeted retrovectors bearing a cytocidal anti-cyclin G1 construct and a controllable GM-CSF expression construct, respectively. The working hypothesis underlying this two-tier complementary approach to tumor eradication and cancer vaccination is that a personalized vaccination of a patient against his or her own specific cancer can be achieved by combining (1) a targeted vector bearing a tumoricidal payload, i.e. Rexin-G, with (2) a targeted vector bearing a potent immuno-stimulatory (GM-CSF) gene, i.e. Reximmune-C. In this model, Rexin-G is first administered to control tumor growth and expose neoantigens within the tumor microenvironment, followed by defined pulses of Reximmune-C, intended to recruit the patient’s immune cells into these lesions, thereby prompting immunologic activation, recognition of tumor neoantigens, and induction of a beneficial antitumor immunity. The initial results of a Phase I/II dose escalation study showed that, in addition to the expected tumoricidal effects of Rexin-G, histopathologic examination of biopsied tumors from patients with a diversity of cancer types revealed targeted nanoparticle delivery, GM-CSF transgene expression, and localized immune responses within the lesions. Importantly, no circulating GM-CSF protein was detected and no dose limiting toxicity was observed throughout the treatment period. Moreover, there appears to be a significant survival benefit which suggests that this two-tier approach has considerable merit as a therapeutic vaccine.

About Epeius Biotechnologies:

Epeius Biotechnologies Corporation (www.epeiusbiotech.com) is a privately held biopharmaceutical company dedicated to the advancement of genetic medicine with the development and commercialization of its lead products, Rexin-G and Reximmune-C, and its high-performance gene delivery systems. To learn more about these agents and/or ongoing clinical trials, please contact Dr. Erlinda M. Gordon at egordon @ epeiusbiotech.com .

News Source: Epeius Biotechnologies Corporation :: This press release was issued by Send2Press® and is Copyright © 2010 Neotrope® News Network – all rights reserved.