The PNAS manuscript can be read in its entirety  HERE.

Many of the world’s largest and most respected pharmaceutical companies have turned to Biomodels to provide superior pre-clinical research. Through its collaborative relationships within the Bio-Pharma community and with leading academic researchers and institutions, Biomodels is able to provide exceptional advice and superior outsourced preclinical research to biotechnology and pharmaceutical companies of all sizes.

Evreux, France and Watertown, MA, USA, December 16, 2010 - CIT, the preclinical drug safety CRO based outside Paris, and Biomodels, the Boston-based service company offering tailor-made preclinical efficacy models, announce today the signature of an alliance agreement. Under the terms of this transatlantic agreement, the two companies will develop packages of integrated services covering the early development of candidate drugs and their passage into the development phase.

The synergy derived from this alliance will enable the two companies to provide their clients with a comprehensive and seamless program of pre-clinical drug development, as well as new high-content testing approaches. Financial details of the agreement were not disclosed.

“CIT is very excited about working with Biomodels especially because of its ability to generate customized preclinical efficacy models,” said Dr Roy Forster, CSO of CIT. “This opens the way to unique approaches that permit rigorous profiling of the clinical potential of candidate drugs. Working hand in hand with Biomodels, we will further enrich our understanding of the efficacy and best therapeutic deployment of new drugs and bring these benefits to our clients.”

“Biomodels too is excited about the prospects offered by working with CIT and being able to share in its wide range of services,” said Professor Stephen Sonis, chief medical officer of Biomodels. “CIT goes well beyond just regulatory toxicology, and has been developing services in biomarkers, multiplex analyses, toxicogenomics and integrated safety pharmacology measurements.”

The two companies will begin their relationship with integrated packages of services that offer clients a seamless program of preclinical drug development. The next step will be to develop high content testing approaches that will provide significant added value for clients.

“CIT’s US affiliate, CITox Inc, is responsible for setting up this agreement, a clear affirmation of CIT’s presence in the US and of our proximity to US clients,” said Sophie Baratte, CEO of CIT. “Through this alliance, CIT and Biomodels are offering early testing capabilities in the US that we will transfer smoothly into preclinical development services in our French facility.”

About Biomodels
Biomodels, a preclinical drug research organization founded in 1997, develops and conducts predictive translational studies for biotechnology and pharmaceutical companies, particularly in the areas of cancer, cancer supportive care, radiation therapy, and inflammatory diseases. The company specializes in (non-GLP) efficacy studies that optimize dose, schedule and define mechanism of action. The company also has particular expertise in modeling inflammatory diseases, including those conditions affecting the gastrointestinal tract.

About CIT
CIT is a science-driven, independent, non-clinical contract research organization (CRO) specialized in safety and health research. Founded in 1969, CIT has carried out a vast number of projects for international companies on human and veterinary pharmaceuticals, biotechnology, chemicals, agrochemicals and consumer products. It has contributed to many product registrations around the world.

With a staff of 360, CIT offers a full range of research in general toxicology, reproductive toxicology, carcinogenicity, pharmacokinetics and safety pharmacology. The company also carries out research into genetic toxicology, in vitro testing and toxicogenomics.
Its 20,000-square metre (215,000 sq ft) facilities located in Normandy, one hour from Paris, France, house all principal laboratory animal species to the highest standards. Laboratory facilities include analytical chemistry and bioanalysis, clinical pathology, genomics and histology. Support facilities include archives and plant buildings. The company is GLP and AAALAC certified.

More than half the company’s business comes from international customers. Overall, 80 per cent of revenues are in the pharmaceutical and biotechnology sector. Biotechnology and start-up companies alone account for 50 per cent.

The company has a world-class team of top-level management in scientific, financial and business activities.

Oral mucositis is a frequent, painful, and debilitating complication of conditioning regimens associated with hematopoietic stem cell transplants (HSCT). The symptoms associated with mucositis are thus considerable and result in significant morbidity as well as increased health care costs. An assay which effectively determines the at-risk patient population for mucositis intervention associated with HSCT is highly desirable. From the perspective of the patients, payers, hospitals, and clinicians a personalized approach to the treatment is a great advantage.

“Swedish Orphan Biovitrum is dedicated to developing, and providing medicines for rare diseases to help people with large medical needs to better lives. The development of assays that enables a personalized medicine approach fits exactly with this mission. We are thus pleased to work with Biomodels, a company well-known for its innovative research in the areas of cancer and cancer supportive care”, said Peter Edman, Chief Scientific Officer at Swedish Orphan Biovitrum

Dr. Stephen T. Sonis, Biomodels‘ Chief Medical; Officer, commented: “We are enormously excited to work with Swedish Orphan Biovitrum to apply our novel approach for patients undergoing aggressive cancer therapy. We are optimistic that as a consequence of this project, patients undergoing hematopoietic stem cell transplant will be able to receive targeted therapies to reduce the burden of these symptoms.”

About Biomodels LLC

Biomodels (www.biomodels.com), a preclinical drug research organization founded in 1997, develops and conducts predictive translational studies for biotechnology and pharmaceutical companies, particularly in the areas of cancer, cancer supportive care, radiation therapy, and inflammatory diseases.  The company specializes in (non-GLP) efficacy studies that optimize dose, schedule and define mechanism of action. The company also has particular expertise in modeling inflammatory diseases, including those conditions affecting the gastrointestinal tract.

About Swedish Orphan Biovitrum

On January 14, 2010, Biovitrum AB (publ) completed the acquisition of Swedish Orphan International Holding AB and created Swedish Orphan Biovitrum – a leading company focused on treatment of rare diseases.

Swedish Orphan Biovitrum is a Swedish based specialty pharmaceutical company with an international market presence. The company is focused on providing and developing orphan and niche specialist pharmaceuticals to patients with high medical needs. The portfolio consists of about 60 marketed products and an emerging late stage clinical development pipe-line within rare diseases. Swedish Orphan Biovitrum has pro-forma revenues 2009e of about 2 BSEK and approximately 500 employees. The head office is located in Sweden and the share (STO: BVT) is listed on NASDAQ OMX Stockholm. For more information please visit www.biovitrum.com.

For more information please contact:

Swedish Orphan Biovitrum may be required to disclose the information provided herein pursuant to the Swedish Securities Markets Act. The information was provided for public release on April 11, 2010 at 8:30 a.m. CET.

Boston, MA (November 16, 2009) — Scientists at Biomodels have successfully developed the first model that accurately duplicates human cancer treatment-related fatigue (CTRF). The new model shows, that as in human cancer patients, fatigue is independent of anemia or weight loss and persists long after cancer treatments end.

The new model and research findings will be presented today at the American Association for Cancer Research-NCI-EORTC Molecular Targets and Cancer Therapeutics meeting in Boston.

Lingering fatigue is a debilitating problem in patients who have been treated for cancer and its etiology is poorly understood. Fatigue is a common side effect of both chemotherapy and radiation therapy that impacts almost all individuals who undergo cancer treatment.

“There is currently no therapy for cancer treatment-induced fatigue,” said Dr. Stephen Sonis, a cancer support care expert and one of the study’s authors. Dr. Sonis also serves on the staff of Brigham & Women’s Hospital and the Dana-Farber Cancer Institute.

“The new model developed by Biomodels mimics the human condition, shedding light on the biological mechanisms involved and opens the door for developing and testing treatments to effectively prevent cancer treatment-related fatigue,” Dr. Sonis said.

Biomodels is a preclinical drug research organization in Watertown, MA that specializes in the areas of cancer supportive care, radiation therapy, and inflammatory diseases.

ABOUT BIOMODELS LLC. Biomodels (www.biomodels.com), a preclinical drug research organization founded in 1997, develops and conducts predictive translational studies for biotechnology and pharmaceutical companies, particularly in the areas of cancer, cancer supportive care, radiation therapy, and inflammatory diseases.

The company specializes in (non-GLP) efficacy studies that optimize dose, schedule and define mechanism of action.  The company also has particular expertise in modeling inflammatory diseases, including those conditions affecting the gastrointestinal tract. Biomodels’ studies enable organizations to more readily identify lead compounds, decrease the time to a clinical trial and increase the chance of clinical success.  
Biomodels is headquartered in Watertown, MA.

The discovery by scientists at Biomodels, a preclinical drug research organization, and Lubris, a Massachusetts-based startup company, could result in a new therapy for individuals at risk for osteoarthritis, researchers said.

The study, by Gregory D. Jay, MD, PhD, a Professor of Emergency Medicine and Biomedical Engineering at Rhode Island Hospital and Brown University, will be presented Monday morning at the American College of Rheumatology/Association of Rheumatology Health Professionals Conference.

In the study performed at Biomodels, the transection of the ACL (anterior cruciate ligament) in untreated rats resulted in progressive degeneration of the knee joints and the articular cartilage. In rats treated with recombinant human lubricin, however, the degeneration was far less pronounced, indicating that treatment with lubricin can slow the development of osteoarthritis following traumatic joint injury, and possibly reverse the process, according to Dr. Jay.

Dr. Jay said the study shows that recombinant human lubricin, given as direct injections, “significantly reduced the extent of cartilage degeneration in the knees of rats with post-traumatic osteoarthritis.”

“If the research can be successfully translated into humans, it would represent the first successful attempt to protect cartilage and improve boundary lubrication in compromised joints, which could revolutionize both the treatment of osteoarthritis and traumatic joint injury,” he said

Dr. Jay’s ongoing research suggests that lubricin injections could delay or even prevent the onset of osteoarthritis and reduce or eliminate the need for costly joint-replacement surgery.

The findings are supportive of more than two decades of research by Dr. Jay and his team, in which they have shown that lubricin is a key component of human synovial fluid, itself a requirement for the normal function and lubrication of healthy joints.

About Lubris LLC

Lubris, a Massachusetts-based startup company, is developing lubricin commercially and holds exclusive worldwide patent rights to make, use, and sell lubricin. The company is in the process of accessing capital markets to develop and commercialize lubricin-containing products in various orthopedic and other indications.

About Biomodels LLC

Biomodels, a preclinical drug research organization founded in 1997, develops and conducts predictive translational studies for biotechnology and pharmaceutical companies, particularly in the areas of cancer, cancer supportive care, radiation therapy, and inflammatory diseases.

The company, based in Watertown, MA, specializes in (non-GLP) efficacy studies that optimize dose, schedule and define mechanism of action. The company also has expertise in modeling inflammatory diseases, including those conditions affecting the gastrointestinal tract. Biomodels’ studies enable organizations to more readily identify lead compounds, decrease the time to a clinical trial and increase the chance of clinical success.

BURLINGTON, MA (Sept. 16) Avaxia Biologics, Inc., a biotechnology company developing oral antibodies for disease targets accessible via the GI tract, announced today that it has been awarded a Phase I SBIR grant from the National Institute of Dental and Craniofacial Research to support the development of a novel antibody therapeutic for oral mucositis.

Avaxia is developing a polyclonal anti-TNF antibody to be administered to the oral cavity of patients suffering from mucositis. The antibody is designed to reduce the pain and ulceration associated with this serious side effect of cancer treatment. The grant will fund key pre-clinical studies of the antibody in a well-established animal model of radiation-induced oral mucositis.

We are delighted to have been awarded this grant from the NIH,” said Barbara S. Fox, Avaxia’s founder and CEO. “Our preliminary data indicate that an anti-TNF antibody, delivered topically to a damaged mucosal membrane, will limit the severity of the inflammatory response induced by ionizing radiation. The support of the NIH provides both the funding we need to advance the development of this much needed therapeutic, and critical scientific validation of our approach.”

Avaxia is carrying out the grant-funded research in collaboration with Biomodels LLC, a Watertown-based pre-clinical drug research organization. Biomodels specializes in animal models of toxicities associated with chemotherapy and radiation therapy used for the treatment of cancer and is a world leader in the study of cancer treatment-related mucosal injury (mucositis) .

We are looking forward to working closely with Avaxia Biologics scientists in developing and testing a drug that could lead to an effective therapy for oral mucositis, a debilitating side effect that impacts virtually every patient who undergoes aggressive cancer treatment,” said Edward Fey, managing partner of Biomodels.

Avaxia and Biomodels anticipate extending their productive collaboration to other therapeutic areas, including inflammatory bowel disease and GI enteritis and fibrosis.

ABOUT ORAL MUCOSITIS. Oral mucositis is a serious side effect of cancer chemotherapy and radiation therapy. According to a 2008 report from the National Comprehensive Cancer Network, mucositis has “emerged as the most significant adverse symptom of cancer therapy reported by patients.” Mucositis is associated with severe pain and risk of infection, necessitating the use of systemic narcotics and the insertion of a feeding tube to provide nutrition. Most significantly, when mucositis develops, the dose and frequency of cancer treatment is often reduced, leading to a significant decrease in both short-term efficacy and long-term disease-free survival. There are no approved medications for the treatment of mucositis associated with most forms of cancer treatment.

ABOUT AVAXIA BIOLOGICS, INC. Avaxia Biologics (www.avaxiabiologics.com) is an early stage company developing orally-delivered antibody therapeutics. The antibodies are designed to treat both diseases of the GI tract and systemic diseases where the disease targets are accessible in the GI tract. Avaxia has a proprietary antibody platform and is developing products for oral mucositis, inflammatory bowel disease, and diabetes and obesity.

ABOUT BIOMODELS LLC. Biomodels (www.biomodels.com), a preclinical drug research organization founded in 1997, develops and conducts predictive translational studies for biotechnology and pharmaceutical companies, particularly in the areas of cancer, cancer supportive care, radiation therapy, and inflammatory diseases.

The company specializes in (non-GLP) efficacy studies that optimize dose, schedule and define mechanism of action. The company also has particular expertise in modeling inflammatory diseases, including those conditions affecting the gastrointestinal tract. Biomodels’ studies enable organizations to more readily identify lead compounds, decrease the time to a clinical trial and increase the chance of clinical success. 
Biomodels is headquartered in Watertown, MA.

SOURCE Avaxia Biologics, Inc. Barbara S. Fox, CEO. 1-508-259-5929

WATERTOWN, Mass., June 22 /PRNewswire/ — Biomodels LLC, a preclinical research organization specializing in cancer support care, today announced that its customized research program allowed ActoGeniX NV, a development stage biopharmaceutical company, to rapidly attain Food and Drug Administration (FDA) approval for Phase 1b clinical trials of AGO13 in cancer patients with oral mucositis.

There is currently no effective cure for the severely painful and debilitating inflammation and ulceration of the mucous membranes lining the mouth that makes eating, drinking and speaking difficult or impossible.

Oral mucositis, can affect up to 100 percent of cancer patients undergoing high dose chemotherapy.

The FDA approval permits ActoGeniX to initiate a phase 1b clinical trial in six major oncology centers in the United States. AGO13 could become the first approved therapy for oral mucositis in patients undergoing treatment of solid tumors or head/neck cancers, according to ActoGeniX.
“The speedy approval of our drug application for AGO13 from the FDA was clearly the result of our successful collaborative efforts with Biomodels scientists who worked closely with us in a complex process involving the development of innovative, high quality platforms,” said Dr. Mark Vaeck, CEO of ActoGeniX.

The preclinical data package that was developed enabled us to identify how AGO13 could be used clinically, ” he said. “We can now seamlessly translate Biomodels’ research into our clinical trials, thus speeding up the drug development process.”

Edward Fey, CEO of Biomodels said, “We are delighted that our collaboration with ActoGeniX will speed the development of an effective therapy for cancer patients suffering from the ravages of oral mucositis. Biomodels was able to provide an innovative and customized program to ActoGeniX. This close collaboration resulted in a very successful outcome.”

“We are very excited about partnering with Biomodels,” said Aman Johar, CEO of APS.”This relationship allows us flexibility to customize our pre-clinical studies, maintain our clinical end-points and effectively utilize capital resources. A full-scale collaboration extends our research platform and provides access to leading scientists and researchers. Biomodels` proven models reliably predict clinical success in an extremely complex field of mucositis. APS products can be the standard of care for preventing mucositis – saving over $2 billion annually in hospitalization costs.”

“Together Biomodels and APS will finalize oral mucositis studies and also rapidly test a number of mechanistically-related therapeutic areas using appropriate validated models,” said Edward Fey, Managing Partner of Biomodels. “This alliance represents a new business model for the outsourcing of pre-clinical services and is designed to fulfill the specific needs of early stage pharmaceutical companies,” Fey adds.

Mucositis remains an unmet medical need and APS products may become the “standard of care”for solid tumor patients undergoing cancer treatment. Mucositis affects over 400,000 patients annually. In a recent survey, 66% of mucositis patients said that physicians need to
be educated more about its treatments. There are currently no approved medications for preventing
mucositis. This collaboration boosts APS efforts to build a technology platform that can be scaled to encompass all aspects of supportive oncology care.

About Applied Protein Sciences

APS is developing proprietary proteins that help with the growth of the mucosal tissue, thereby preventing the onset of mucositis. With APS` products, patients can remain on chemotherapy or radiation for longer, significantly increasing their survival. In addition to
mucositis, APS drug platform includes candidates for proctitis and IBD – significant unmet medical needs in supportive oncology care. APS aims to secure orphan drug status and has a broad
portfolio of issued US and worldwide patents rights. APS recently released a mechanism of action for its drug candidates. APS is privately owned and investors include Innovation Management Sciences.

www.appliedprotein.com

About Biomodels

Biomodels is a preclinical CRO helping biotechnology companies enter clinical trials phase of the drug development process. Biomodels specializes in screening studies to evaluate efficacy and define mechanism of action to expedite the process. Over the years Biomodels core competencies in oncology and cancer supportive care include a range of inflammatory and mucosal diseases. The net effects are preclinical data that are meaningfully translatable to the clinic and added confidence in the design of clinical studies, all of which conveys substantial cost savings.

www.biomodels.com