Sartorius Stedim Biotech & RAUMEDIC Sign Partnership Agreement

Sartorius Stedim Biotech (SSB), an international leading pharma and biotech supplier, and RAUMEDIC, a leading worldwide OEM manufacturer of medical- and pharmaceutical-grade polymer components and systems, recently announced the signing of a global partnership agreement. This covers arrangements concerning the mutual development of innovative fluid systems and marketing of single-use tubing, which RAUMEDIC produces for and will supply to Sartorius Stedim Biotech on a long-term basis.

Sartorius Stedim Biotech will be combining its designing, manufacturing, and validation expertise in single-use systems for biopharmaceutical applications with RAUMEDIC proficiency in the development and manufacture of tubing for medical and biopharmaceutical use. The alliance will provide innovative, high-quality, and reliable fluid handling systems to biopharmaceutical manufacturers. Through this strategic partnership with RAUMEDIC, Sartorius Stedim Biotech will substantially expand its product and service portfolio in the area of liquid transfer technologies.

The companies will strengthen and develop their existing long-term collaboration and merge their expertise for generating new tubing technologies and validation standards. With a new product line, TuFlux, which will soon be launched, Sartorius Stedim Biotech will supply its customers with highly validated polymer and silicone tubing on single-use assemblies as well as stand-alone tubing coils, along with comprehensive validation packages. According to the agreement, Sartorius Stedim Biotech will offer its products backed by RAUMEDIC’s support and assistance in order to develop customized solutions and to provide stronger validation and technical support as well as process improvements.

Jean-Marc Cappia, Vice President of Fluid Management Technologies of Sartorius Stedim Biotech, acknowledges the agreement as an important milestone in expanding SSB’s product portfolio.

“More than ever, we offer the full capabilities of single-use technologies. For our customers of the biopharmaceutical industry, this partnership will yield a powerful combination of single-use bags, filters, connectors, sensors, and tubing systems and services. Our long-term expertise in characterizing extractables in filters and bags will benefit our tubing technology and hence, we will be offering more comprehensive validation packages for our single-use solutions.”

RAUMEDIC is bringing to Sartorius Stedim Biotech more than 60 years of technical expertise and manufacturing excellence in the area of polymer-based systems and components for medical and pharmaceutical applications. The company is renown in material development, compounding of raw materials, and extrusion technologies of all kinds for polymer and elastomer tubing.

“This alliance will provide integrated, single-use systems to the global biopharmaceutical industry, which have been developed and harmonized by two strong partners in this area,” added Martin Bayer, CEO of RAUMEDIC.

Talon Therapeutics to Commence Phase III Study of Marqibo

Talon Therapeutics, Inc. recently announced the initiation of a Phase III study of Marqibo (vincristine sulfate liposomes injection) in elderly patients with newly diagnosed aggressive Non-Hodgkin’s Lymphoma to be conducted by the German High-Grade Non-Hodgkin’s Lymphoma Study Group (DSHNHL).

“The German High-Grade Non-Hodgkin’s Lymphoma Study Group is one of the most well-regarded hematologic malignancy-focused cooperative groups in the world, and we are very pleased to be supporting them in this important study,” said Steven R. Deitcher, MD, President, Chief Executive Officer, and Director of Talon Therapeutics. “We agree with DSHNHL that Marqibo facilitated vincristine dose intensification while maintaining a predictable and manageable safety profile in NHL has the potential to benefit patients.”

This Phase III, randomized study, expected to begin patient treatment in the third quarter of 2011, builds upon Phase II data from a study of Marqibo in NHL that is currently under review at a major oncology journal. The title of the DSHNHL study is Improvement of Outcome and Reduction in Toxicity in Elderly Patients With CD20+ Aggressive B-cell Lymphoma by an Optimized Schedule of the Monoclonal Antibody Rituximab, Substitution of Conventional by Liposomal Vincristine and FDG-PET Based Reduction of Therapy.

The study will enroll approximately 1,000 patients (61-80 years of age) with aggressive CD20+ B-cell NHL. The primary objectives are to test the effects of substituting conventional vincristine with Marqibo in the R-CHOP regimen and to test the effects of an optimized application of rituximab. The Principal Investigator for this study is the internationally recognized Professor Dr. Michael Pfreundschuh.

Talon and DSHNHL completed protocol development and an investigator meeting, and anticipate first-patient-in during the third quarter of 2011. Talon will fund a portion of this Phase III study in NHL as part of its Marqibo development program.

Marqibo is a novel, targeted Optisome-encapsulated formulation product candidate of the FDA-approved anticancer drug vincristine. Until now, Talon has been primarily developing Marqibo for the treatment of adult, Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL). Vincristine, a microtubule inhibitor, is FDA approved for ALL and is widely used as a single agent and in combination regimens for treatment for hematologic malignancies, such as lymphomas and leukemias. Talon’s encapsulation formulation is designed to provide prolonged circulation of the drug in the blood and accumulation at the tumor site. These characteristics are intended to increase the dose of vincristine delivered in a safe and effective manner.

Talon plans to submit to the FDA an NDA seeking accelerated approval of Marqibo in adult Ph-ALL, in second or greater relapse or that has progressed following two or more prior lines of anti-leukemia therapy, by the end of June 2011. Talon has received orphan drug and fast-track designations for Marqibo for the treatment of adult ALL from the US FDA. Marqibo has also received orphan drug designation in adult leukemia from the European Medicines Evaluation Agency.

Talon Therapeutics, Inc. is a biopharmaceutical company dedicated to seizing upon medical opportunities, efficiently and expertly leading product candidates through clinical development, and transferring value to patients, patient care providers, shareholders, corporate partners, and employees. In addition to Marqibo, the company has additional pipeline opportunities some of which, like Marqibo, have the potential to improve delivery and enhance the therapeutic benefits of well-characterized, proven chemotherapies and enable high-potency dosing without increased toxicity.

TxCell Receives Approval for Phase I/II Clinical Trial Extension

TxCell SA, a biotechnology company developing cell-based immunotherapies for the treatment of severe chronic inflammatory diseases with high unmet medical need, recently announced the approval by AFSSAPS, the French regulatory agency, of its application to extend treatment of patients included in the Crohn’s Disease Phase I/II study (CATS1) with Ovasave, a type 1 regulatory T cell-based immunotherapy.

CATS1 (Crohn And Tr1 Study) is a Phase I/II trial designed to evaluate the tolerability and explore the efficacy of Ovasave in patients with severe chronic active Crohn’s Disease, who failed current treatments, including biologics. In the first part of the study completed in April 2010, Ovasave administration was well tolerated and showed evidence of a beneficial effect in the overall population of patients. The now approved extension of CATS1 is destined to address the requests from investigators of continuing treatment in patients that benefited from the initial Ovasave administration.

“There are limited options for the management of severe refractory Crohn’s Disease patients. We have conducted CATS1 to explore our innovative cellular-based immuno-regulatory approach for the treatment of these patients,” said Miguel Forte, Chief Medical Officer of TxCell. “The open label study extension now approved will help to address the unmet medical need in some of the severe patients recruited in CATS1.”

“We are delighted and encouraged by the investigators’ and patients’ assessment of Ovasave treatment benefit,” added Francois Meyer, Chief Executive Officer of TxCell. “We are now committed to confirm these results in a controlled Phase IIb study and to progress the development plan of our lead product candidate, Ovasave.”

Ovasave, a type 1 regulatory T cell-based immunotherapy, is TxCell’s leading product candidate for the treatment of inflammatory bowel diseases like Crohn’s Disease. The Tr1 cells utilized in Ovasave are isolated from whole blood of the patient, activated by the specific antigen, ovalbumin. The cloned Tr1 cells are expanded ex vivo before their reinjection into that same patient. The injected Tr1 cells home to sites of inflammation and are activated locally by the specific food antigen, ovalbumin.

TxCell, a spin-off of Inserm (France’s National Institute for Health and Medical Research) located in the technology park of Sophia Antipolis, near Nice in southern France, is developing cell-based immunotherapies for the treatment of severe chronic inflammatory diseases with high medical need using its unique and proprietary technology platform based on the properties of Type 1 regulatory T lymphocytes (Tr1 cells). The company has completed enrollment of a Phase I/II study in refractory Crohn’s Disease patients and has reported first positive results. The company plans to initiate a Phase IIb study in the same patient population and to bring a second product candidate into a Phase I/II study in refractory rheumatoid arthritis patients.

Critical Outcome Technologies Initiates Development of Optimal Oral Oncology Formulation

Critical Outcome Technologies Inc. recently announced it has initiated a project to develop an optimal oral formulation of COTI-2. This lead oncology product has demonstrated efficacy as a single agent and in combination therapy in a number of animal models of human cancers. Development of an oral formulation for use in humans will maximize the amount of an orally administered dose that is absorbed into the body.

Following the completion of a successful private placement in April, COTI announced its intention to launch three studies related to the continued development of COTI-2 based on scientific and business feedback from prospective licensing partners. The first study, a pharmacodynamic animal experiment, is already underway. This recent announcement represents the initiation of the second research study. An agreement between COTI and Xcelience Formulation Development, LLC (Xcelience) of Tampa, FL, was signed on May 2, 2011, and work on the project is now underway.

The third study will be the completion of the 28-day Good Laboratory Practice (GLP) toxicity experiments in two species that forms part of the Investigational New Drug (IND) enabling experiments required by the Federal Drug Administration prior to beginning clinical trials.

“We are committed to achieving all three of these COTI-2 developmental milestones, and we are pleased with the initiation of the oral formulation optimization project,” said Dr. Wayne Danter, COTI’s CEO and President. “Xcelience is a recognized industry leader with an impressive track-record of success in formulating more than 100 development-stage small molecules for clinical use.”

“We are pleased to be recognized for our strength in formulation development expertise and selected for the COTI-2 program,” said Derek G. Hennecke, CEO and President of Xcelience. “The partnership that has developed is a great example of the value two companies can create when they work together to achieve program objectives.”

COTI-2 has shown itself to be highly effective both as a single agent and in combination therapy in a number of animal models of human cancers. Other cancer treatments involve the killing of healthy growing and dividing cells in the body, resulting in significant toxic side effects, while COTI-2 appears to target and destroy cancer cells only and has demonstrated low toxicity in normal human cells compared to human cancer cells. The combined scientific evidence indicates that COTI-2 is an ideal agent for combination therapy with current standard agents for a number of cancers, including small cell lung, non-small cell lung, colon, brain, ovarian, endometrial, triple negative breast, and pancreatic.

In scientific terms, COTI-2 is a novel small molecule that acts by inhibiting Akt/PKB phosphorylation that leads to caspase-9 activation in cancer cells resulting in tumor cell death. COTI-2 has demonstrated greater selectivity as well as an improved safety profile and pharmacokinetics in comparison to other Akt inhibitors. COTI is currently evaluating partners to share in the development of COTI-2 via a licensing agreement.

Xcelience is a contract research organization providing formulation development, preformulation, analytical, and clinical trial manufacturing to a global client base since 1997. The company is renowned for reliably expediting early development activities to speed potential drugs to clinical trials while applying stage-specific scientific knowledge and experience. Xcelience’s unique corporate structure creates project teams that work intensively with each client, bringing an extension of their own organization into the Xcelience lab.

COTI is a leading-edge biotechnology firm specialized in assisting pharmaceutical, biotechnology, and therapeutic companies with the accelerated discovery of small molecules to enable new drugs to be brought to market in a more timely, cost-effective, and efficient manner. COTI’S proprietary technology CHEMSAS, utilizes a series of predictive computer models to identify compounds most likely to be successfully incorporated in disease-specific drug discovery, as well as subsequent optimization and preclinical development. These compounds are targeted for a variety of diseases, particularly those for which current treatments are either lacking or ineffective.

Infinity Initiates Randomized Phase II Trial of Novel Hsp90 Inhibitor

Infinity Pharmaceuticals, Inc. recently announced the initiation of a Phase II clinical trial of retaspimycin hydrochloride (HCl), also known as IPI-504, the company’s novel heat shock protein (Hsp90) inhibitor, in combination with docetaxel (also known as Taxotere) in patients with non-small cell lung cancer (NSCLC). This study is supported by encouraging data from a Phase Ib trial in which retaspimycin HCl in combination with docetaxel was well-tolerated and showed clinical activity in NSCLC patients with poor prognoses, including patients with squamous cell carcinoma or with a history of heavy smoking.

The adaptive, randomized, placebo-controlled Phase II trial will evaluate the anti-tumor activity, tolerability, and safety of retaspimycin HCl in combination with docetaxel compared to docetaxel alone in approximately 100 second- or third-line NSCLC patients who are naive to docetaxel treatment. Following an interim analysis to evaluate the relationship between efficacy and certain patient characteristics, including histology, tobacco exposure, and a variety of biomarkers, Infinity may expand the trial in patient populations that respond preferentially to treatment with retaspimycin HCl in combination with docetaxel. The study may be expanded based on overall response rate.

“We are encouraged by the results seen in our Phase Ib trial in which response rates in NSCLC patients with a poor prognosis and limited treatment options were among the highest seen to date,” said Pedro Santabarbara, MD, PhD, Chief Medical Officer at Infinity. “These clinical results suggest that retaspimycin HCl may provide an important therapeutic benefit in specific forms of NSCLC when used as part of combination therapy. We look forward to validating our early findings in a rigorous, adaptive Phase II clinical trial designed to quickly and efficiently identify the patients most likely to benefit from this combination.”

In addition to the Phase II trial of retaspimycin HCl in combination with docetaxel, Infinity plans to begin a second clinical trial of retaspimycin HCl in patients with NSCLC by this summer. The second study is based on preclinical data of retaspimycin HCl as part of combination therapy in a molecularly defined subset of patients.

Infinity also announced it has completed a preliminary review of data from two Phase I dose-escalation trials of IPI-493, its oral Hsp90 inhibitor, in patients with solid tumors and hematological malignancies. Since drug exposure of retaspimycin HCl was superior to IPI-493, Infinity intends to focus its efforts exclusively on retaspimycin HCl.

The Phase Ib study included an expansion cohort of 23 NSCLC patients treated with retaspimycin HCl dosed once weekly in combination with docetaxel administered once every 3 weeks. There were six confirmed objective responses in this NSCLC cohort, for an overall response rate of 26%. Patients with squamous cell carcinoma or with a history of heavy smoking appeared to respond preferentially to the combination, with overall response rates of 43% (N = 3/7) and 33% (N = 6/18), respectively.

The combination of retaspimycin HCl and docetaxel was well-tolerated. Side effects were manageable, and docetaxel pharmacokinetics were unaltered by co-administration of retaspimycin HCl. The most common adverse events observed were Grades 1 and 2, and the most common treatment-related adverse events were fatigue, diarrhea, nausea, vomiting, neutropenia, and anemia.

“In this trial, retaspimycin HCl was well-tolerated, and the clinical activity observed suggests that combination therapy with retaspimycin HCl may be a promising treatment strategy for specific forms of NSCLC,” said Gregory J. Riely, MD, PhD, Assistant Attending Physician, Medical Oncology, Memorial Sloan-Kettering Cancer Center, and the Lead Investigator for the Phase Ib trial.

Cancer cells depend on the heat shock protein 90 (Hsp90) chaperone to maintain many proteins critical for cancer growth, proliferation, and survival in a functional state. Certain anti-cancer therapies may enhance the dependency of cancer cells on the Hsp90 chaperone. Therefore, combining an Hsp90 inhibitor, such as retaspimycin hydrochloride (HCl), with another proven anticancer agent may enhance cancer cell killing.

Infinity is an innovative drug discovery and development company seeking to discover, develop, and deliver to patients best-in-class medicines for difficult-to-treat diseases. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging disease pathways. Infinity’s programs in the inhibition of the Hedgehog pathway, the Hsp90 chaperone system, fatty acid amide hydrolase, and phosphoinositide-3-kinase are evidence of its innovative approach to drug discovery and development.

PolyPid Announces Revolutionary Drug Delivery System

PolyPid, a developer of innovative drug carriers, recently announced the company’s flagship platform – PolyPid, an innovative family of drug carriers, based on a fusion between two known drug delivery systems: polymers and lipid-based systems. The new drug carriers enable long-lasting and controlled release of therapeutic drugs. The revolutionary, patented carrier can be tailored to almost any drug – small molecules, peptides, proteins, and nucleic acids-based drugs. The formulations can be pre-planned in order to achieve the desired release rate of the drug/s and the optimal duration, which can last up to several months.

“PolyPid is a groundbreaking drug carrier that will help pharmaceutical and biotech companies enhance their drugs and meet their challenges,” said Dr. Noam Emanuel, PolyPid’s Chief Technology Officer. “Due to its flexibility, the PolyPid platform can be utilized to address numerous medical indications in various fields, such as orthopedics, urology, periodontal, anti-cancer/anti-fungal treatments and surgical accessories.”

PolyPid technology makes it possible to entrap a large variety of one or more biologically active molecules, and to release them at a pre-programmed rate for up to several months, all according to the desired clinical rate. During its long-lasting effect, the drug reservoir is fully protected from both biodegradation and hydration.

The first PolyPid-based solution is BonyPid, biodegradable bone void filler that is micro-coated with a PolyPid biodegradable formulation. The coating gradually releases one or more selected antibiotics into its surroundings. Subsequently, the bone void filler scaffold remains and supports bone recovery. Thus, using BonyPid will not change the current method of treatment that used bone grafting. The physician will simply replace the conventional bone void filler with BonyPid to obtain the benefits of conventional bone void filler combined with an effective local drug delivery system.

Due to its flexibility, the PolyPid platform can be utilized to address numerous medical indications in various fields, such as orthopedics, urology, periodontal, anti-cancer/anti-fungal treatments, and surgical accessories. PolyPid Ltd. is owned by Xenia Venture Capital, private investors, and the founders.