Lorus Therapeutics : Allowance of New United States Patent for its Anticancer Drug LOR-2040

Jul 29, 2008 -- Lorus Therapeutics Inc. (TSX: LOR, AMEX: LRP), a biopharmaceutical company specializing in the research and development of pharmaceutical products and technologies for the management of cancer, announced the allowance of a new patent from the United States Patent and Trademark Office for its clinical-stage anticancer drug LOR-2040.
The patent, which was issued this month as U.S. Patent No. 7,405,205, protects methods of treating leukemia with LOR-2040, both alone and in combination with chemotherapy drugs. The patent also covers methods of treating specific solid cancers with LOR-2040, including colon, lung, breast, and bladder cancers. LOR-2040 composition as well as its design and use as a unique anticancer drug is currently protected in the U.S. under a separate patent issued in 1999... [PDF] Lorus Therapeutics' Press Release -

Curis : Hsp90 Inhibitor CUDC-305 as Development Candidate from Targeted Cancer Drug Development Platform

Jul 21, 2008 - Curis, Inc. (NASDAQ: CRIS), a drug development company focused on seeking to develop the next generation of targeted small molecule drug candidates for cancer treatment, announced that the Company has selected an orally available, synthetic small molecule inhibitor of heat shock protein 90 (Hsp90) as a development candidate from its targeted cancer drug development platform. In addition to demonstrating potent efficacy across a broad range of cancers in preclinical cancer models, CUDC-305 exhibits promising pharmacological features, particularly its high oral bioavailability, high tumor penetration and extended tumor retention...
...In both laboratory and animal testing, CUDC-305 demonstrated high potency in vitro and/or in vivo across a wide range of cancers. Most notably, Curis scientists observed complete tumor regression following oral administration of CUDC-305 in a mouse xenograft model of acute myelogenous leukemia (AML). Tumor regression has also been observed after treatment of CUDC-305 in mouse xenograft models of breast, non-small cell lung, gastric cancer and glioblastoma brain cancers... Curis' Press Release -

AngioDynamics : Radiofrequency Ablation Yields High Proportions of Sustained Complete Responses in Patients with Lung Cancer

July 14, 2008 - AngioDynamics (NASDAQ:ANGO) announced results from its RAPTURE study, which was conducted to identify the feasibility, efficacy and safety of percutaneous radiofrequency ablation (RFA) of malignant lung tumors. Published in The Lancet Oncology July 2008 issue, the results show a high proportion of sustained, complete tumor response after treatment with RFA.

This prospective, intention-to-treat clinical trial enrolled 106 patients with 183 lung tumors that were 3.5 cm in diameter or smaller (mean 1.7 cm) at seven centers in the United States, Europe, and Australia. Diagnoses included non-small-cell lung cancer (NSCLC) in 33 patients, metastasis from colorectal carcinoma in 53 patients, and metastasis from other primary malignancies in 20 patients. Patients underwent radiofrequency ablation in accordance with standard rules for CT-guided lung biopsy and were then followed for a minimum of 2 years. All patients were considered by their treating physician to be unsuitable for surgery, radiotherapy or chemotherapy... AngioDynamics' Press Release -

ImmunoGen : Start of IMGN388 Clinical Testing

July 7, 2008 - ImmunoGen, Inc. (Nasdaq: IMGN) announced the start of patient dosing in a Phase I clinical trial evaluating the Company's IMGN388 targeted anticancer compound for the treatment of solid tumors. IMGN388 uses ImmunoGen's Tumor-Activated Prodrug (TAP) technology with an antibody that binds to an integrin target. ImmunoGen submitted the Investigational New Drug (IND) application for IMGN388 to the US Food and Drug Administration in mid-May 2008 and gained authorization to initiate clinical testing in mid-June 2008...
... IMGN388 consists of the Company's DM4 cell-killing agent attached to an antibody that binds specifically to an integrin expressed on a wide range of solid tumors - melanomas, sarcomas and many carcinomas, including lung, bladder, renal cell and thyroid carcinomas... ImmunoGen's Press Release -

Resolvyx Pharmaceuticals : First In-Vivo Data Showing Resolvins Suppress IL-23 and IL-17, Key Mediators of Inflammatory Disease

July 3, 2008 -- Resolvyx Pharmaceuticals, Inc., the leading resolvin therapeutics company, announced that a research team led by a Resolvyx scientific advisor and a company co-founder has demonstrated that the resolvin E1 (RvE1) effectively suppresses IL-23 and IL-17, two key inflammatory mediators of chronic inflammatory disease, in a preclinical model of asthma. RvE1 is the active ingredient in RX-10001, one of Resolvyx’s leading clinical candidates. The paper, titled "Resolvin E1 regulates interleukin 23, interferon-δ and lipoxin A4 to promote the resolution of allergic airway inflammation," published in the journal Nature Immunology... Resolvyx Pharmaceuticals' Press Release -

Illumina Infinium High-Density (HD) DNA Analysis Products to Study 90,000 Samples

Jul 01, 2008 - Illumina, Inc. (NASDAQ:ILMN) announced that researchers participating in a new initiative funded by the Wellcome Trust selected Illumina's Infinium HD BeadChips to analyze 90,000 DNA samples. This new initiative aims to decipher the molecular basis of human disease and includes participation from leading research groups around the globe. Together, researchers at the Wellcome Trust Case Control Consortium 2 (WTCCC2) and 12 independent consortia will collect more than 120,000 DNA samples and analyze them for both single nucleotide polymorphisms (SNPs) and copy number variants (CNVs). This new series of genome-wide association studies are collectively the world's largest genetic research initiative conducted to date, and is expected to uncover genetic variants linked to many diseases such as multiple sclerosis, schizophrenia, and asthma. In addition to 90,000 samples collected from study participants, 6,000 control samples will be collected and analyzed using Illumina's Infinium HD Human1M-Duo BeadChip... Illumina's Press Release -

Talecris Biotherapeutics : Orphan Drug Designation for Aerosolized Form of Alpha-1 Antitrypsin (AAT) From the European Commission

July 24, 2008 — Talecris Biotherapeutics, Inc. announced that the European Commission followed an opinion of the Committee for Orphan Medicinal Products (COMP) and has granted orphan drug designation to Talecris’ alpha₁ proteinase inhibitor [human] for inhalation use in the treatment of congenital Alpha₁-Antitrypsin Deficiency (also known as AAT Deficiency or Alpha-1). Currently, there are no approved aerosolized treatments available for augmentation therapy for AAT Deficiency...
...About Alpha₁-Antitrypsin Deficiency
Severe Alpha₁-Antitrypsin Deficiency, also known as AAT Deficiency or Alpha-1, is an inherited disorder that causes a significant reduction of the serum concentration of the naturally occurring protein AAT. It is most common in the Caucasian population of northern Europe and North America. AAT Deficiency is also the most common cause of genetic liver disease in children. In adults, AAT Deficiency is associated with a predisposition for severe chronic obstructive pulmonary disease (COPD), especially early-onset emphysema causing disability and premature death. An estimated 100,000 people in the United States have AAT Deficiency. In Europe, the prevalence of AAT Deficiency is about 2.5 in 10,000 individuals... Talecris Biotherapeutics' Press Release -

FoldRx : Novel Therapeutic Approach for Treating Cystic Fibrosis

July 8, 2008 - FoldRx Pharmaceuticals, Inc. (FoldRx) announced that it has discovered a series of novel drug prototypes that have shown potential in vitro to correct the protein-folding defect associated with cystic fibrosis (CF). The discovery, made through a research collaboration announced last year with Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT), the nonprofit affiliate of the Cystic Fibrosis Foundation, may pave the way to novel drugs capable of repairing the protein misfolding associated with cystic fibrosis, thus helping treat the underlying cause of the disease. The discovery was made using FoldRx's proprietary yeast-based, high throughput screening platform... FoldRx Pharmaceuticals' Press Release -

Emergent BioSolutions and the University of Oxford Joint Venture to Develop an Advanced Tuberculosis Vaccine with ...

July 23, 2008 - Wellcome Trust and Aeras Global TB Vaccine Foundation have agreed to provide GBP 8 million in funding for Phase IIb clinical trial that is expected to commence in 2009 - The vaccine candidate, MVA85A, has been granted orphan drug designation by the European Medicines Agency (EMEA) - If successful, MVA85A would be the first new vaccine licensed to prevent tuberculosis in over 80 years-
The University of Oxford and Emergent BioSolutions Inc. (NYSE:EBS) announced that they have formed a joint venture, The Oxford-Emergent Tuberculosis Consortium Ltd. (the "Consortium"), to further develop MVA85A, the world's most clinically advanced vaccine candidate for the prevention of tuberculosis. The University of Oxford, through its technology transfer office, Isis Innovation Limited, has exclusively licensed the MVA85A tuberculosis vaccine candidate and related technology to the Consortium.

The Consortium will work with the Aeras Global TB Vaccine Foundation to evaluate the efficacy of MVA85A in infants in a Phase IIb clinical trial anticipated to begin in 2009. The trial will take place at a clinical trial site developed by Aeras and the University of Cape Town's South African Tuberculosis Vaccine Initiative (SATVI) in Worcester, South Africa. The Consortium has secured GBP 8 million (approximately $16 million) from The Wellcome Trust and the Aeras Global TB Vaccine Foundation to fund this Phase IIb trial. Under agreements with the Consortium, Emergent BioSolutions has the rights to commercialize the MVA85A vaccine. The Aeras Global TB Vaccine Foundation will have distribution rights in the developing world to ensure availability and access to the vaccine to those who need it... Emergent BioSolutions' Press Release -

Nabi Biopharmaceuticals : Positive Interim Results of NicVAX Immunogenicity Study

Jul 23, 2008 - Nabi Biopharmaceuticals (Nasdaq:NABI) announced positive interim results from its Phase 2 NicVAX(r) (Nicotine Conjugate Vaccine) schedule optimization immunogenicity study to assess the antibody response and safety of a 400 microgram, six dose immunization schedule.

Interim results from the study indicate that significantly higher anti-nicotine antibody levels can be generated three months earlier and in a much higher percentage of subjects than observed in previous NicVAX studies. Nabi's new immunization schedule, which included an additional injection at three months, resulted in an immune response at 14 weeks that was higher than the peak antibody level achieved following the six month booster in the Phase 2b proof of concept study. Significantly, the data indicated that more than 80% of subjects achieved the target antibody level at 14 weeks compared to 50% of subjects in the Phase 2b proof of concept study at the same time point. The revised schedule was well tolerated with an adverse event profile comparable to previous NicVAX clinical studies... Nabi Biopharmaceuticals' Press Release -

OSI Pharmaceuticals : Clinical Development Program for OSI-027 in Patients with Advanced Solid Tumors or Lymphoma

Jul 15, 2008 - OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced that it has initiated a Phase I clinical trial of OSI-027, an oral, potent and selective inhibitor of both the TORC1 and TORC2 complexes that inhibits the kinase activity associated with mTOR (mammalian target of rapamycin). The study is designed to determine the maximum tolerated dose (MTD) and to establish the recommended dose and dosing schedule for Phase II trials, and will evaluate the safety and pharmacokinetic profiles of OSI-027. Preclinical studies demonstrated that orally administered OSI-027 has the potential for anti-tumor efficacy in a broad range of human cancers that depend on the mTOR pathway for tumor growth and survival, such as ovarian, colorectal, breast, lung, prostate and brain cancers, in addition to lymphoma... OSI Pharmaceuticals' Press Release -

Threshold Pharmaceuticals : Interim Results From a Phase 1 Clinical Trial of TH-302 for Solid Tumors At AACR Conference On Translational Medicine

Jul 22, 2008 - Threshold Pharmaceuticals, Inc. (Nasdaq:THLD) announced a presentation on its clinical stage hypoxia-activated prodrug, TH-302, at the American Association for Cancer Research (AACR) Centennial Conference on Translational Cancer Medicine: Cancer Clinical Trials and Personalized Medicine, being held July 20-23, 2008, at the Hyatt Regency Hotel in Monterey, CA. Translational research with the incorporation of laboratory scientific breakthroughs into the medical treatment of cancer is a priority of the AACR which views this conference, and others like it, as a forum for current advances in translational cancer medicine and progress against cancer.
Select interim results were presented from an ongoing Phase 1 clinical trial evaluating the safety and preliminary efficacy of TH-302 in patients with advanced solid tumors. The clinical trial was designed with an initial accelerated titration design followed by a standard dose escalation schema. The trial has completed the accelerated titration design component and has enrolled the eighth dosing cohort. The weekly dose has been escalated from the initial dose of 7.5 mg/m2 to 670 mg/m2. None of the 20 patients enrolled to date has experienced any dose limiting toxicities (DLTs). Importantly, one patient with refractory small cell lung cancer metastatic to the liver had a partial response at their initial response assessment with a greater than 45% reduction in target lesion diameters. The patient, who has received two cycles of TH-302 at 480 mg/m2, is being followed by RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Additionally, this patient experienced a marked improvement in liver function tests. Other anti-tumor activity observed include one patient with non-small cell lung cancer with tumor shrinkage lasting over 6 months... Threshold Pharmaceuticals' Press Release -

Genentech : Receipt of Proposal From Roche

July 21, 2008 - Roche (SWX: ROG.VX; RO.S; OTCQX; RHHBY), a world-leading healthcare company, announced that it has proposed to acquire the outstanding publicly held interest in Genentech (NYSE: DNA ), a leading biotechnology company, for US$89.00 per share in cash, or a total payment of approximately US$43.7 billion to equity holders of Genentech other than Roche. Roche acquired a majority in Genentech in 1990 and currently owns 55.9% of all outstanding shares...


...Roche's significant investment in Genentech over many years has helped it to focus on innovation and long-term projects, leading to some of the most important breakthroughs in the treatment of cancer and other life-threatening diseases. The transaction will create a unique opportunity to evolve Roche's hub-and-spoke model into a structure that allows us to strengthen the focus on innovation and accelerate the search for new solutions for unmet medical needs... Roche's Press Release - Genentech's Press Release -

Alfacell : Novel Combination of Alfacell's ONCONASE(R) and Rosiglitazone Induces a Synergistic Apoptotic Effect in Several Cancer Cell Lines

July 21, 2008 - Alfacell Corporation (Nasdaq: ACEL) announced that a paper published in Molecular Cancer Therapeutics (2008; 7(7):1871-9) reports that a combination of ONCONASE (ranpirnase) and the thiazolidinedione antidiabetic drug rosiglitazone shows a promising effect for cancers with increased expression of PI3K-dependent Fra-1 expression or Survivin.

The paper is the result of NIH-funded in vitro research conducted at the University of Vermont in Burlington, Vt., investigating two known phosphatidylinositol 3-kinase (PI3K) downstream proteins, Fra-1 and Survivin, as potential targets for cancer therapy. The study demonstrated that the combination of ONCONASE and rosiglitazone synergistically decreased cell viability and increased cell apoptosis in several cancer cell lines, including lung, breast, prostate and ovarian, due to decreased Fra-1 and Survivin expression. The results also suggest that combined therapeutic use may overcome the resistance produced in some cancer cells by the activation of survival pathways and their targets. The study concludes the novel drug combination of ONCONASE and rosiglitazone is a promising combination... Alfacell's Press Release -

Luminex and ViroNovative : License Agreement for Human Metapneumovirus Rights

Jul 14, 2008 - Luminex Corporation (NASDAQ: LMNX), the worldwide leader in multiplexed solutions, and ViroNovative BV announced that the companies have signed a licensing agreement that gives Luminex worldwide rights to use ViroNovative's human metapneumovirus (hMPV) intellectual property in the xTAG Respiratory Viral Panel (RVP).
Under the terms of the agreement, rights to ViroNovative's hMPV intellectual property will be extended to Luminex's distributors and end-user customers around the world... Luminex's Press Release -

Schering-Plough and Merck & Co. : Withdrawal of Loratadine/Montelukast NDA and Termination of Respiratory Joint Venture

June 27, 2008 - Schering-Plough Corp. (NYSE: SGP) and Merck & Co., Inc. (NYSE: MRK) announce the withdrawal of the New Drug Application (NDA) for the loratadine/montelukast combination tablet.
The companies also terminated the Schering-Plough/Merck Pharmaceuticals respiratory joint venture, which was formed in May 2000 to develop and market a fixed-combination product that would combine loratadine and montelukast.
This action has no impact on the business of the Merck/Schering-Plough cholesterol joint venture... Merck's Press Release - Schering-Plough's Press Release -

RegeneRx : First Patent on TB4's Ability to Repair Lung Damage Resulting from Infections and Other Disorders

June 24, 2008 — RegeneRx Receives First Patent on TB4's Ability to Repair Lung Damage Resulting from Infections and Other Disorders - RegeneRx Biopharmaceuticals, Inc. (AMEX: RGN) announced that it has received an Australian patent for the use of TB4, its derivatives, analogues and fragments, to repair pulmonary damage resulting from pulmonary microbial infections. The patent expires in 2023.
TB4 is a synthetic version of a biologically active, naturally occurring peptide that has been shown, in pre-clinical studies, to be effective in accelerating dermal, ophthalmic, and myocardial wound healing. TB4 may also be important in other areas of tissue and organ repair, as well as tissue protection. RegeneRx is currently sponsoring five clinical trials and expects to report data later this year on several of these studies... RegeneRx Biopharmaceuticals' Press Release -

BioNumerik Pharmaceuticals : Evidence of a Survival Increase in Lung Cancer Patients Participating in Tavocept Clinical Trial

July 17, 2008 - Second instance where survival increase is observed in advanced non-small cell lung cancer patients receiving Tavocept in conjunction with standard chemotherapy

- Median survival increase of 6.5 months seen for patients with adenocarcinoma, the most common type of lung cancer - BioNumerik Pharmaceuticals, Inc. (“BioNumerik”) announced that patients with adenocarcinoma (the most frequently occurring form of lung cancer) participating in a Phase II clinical trial of Tavocept™ showed a survival increase of approximately 198 days (6.5 months). The trial observations included an approximate 40% reduction in mortality for adenocarcinoma patients receiving Tavocept. The percentage of adenocarcinoma patients in the Tavocept group who were alive after 12 months (One-year survival) was 58% compared to 37% for adenocarcinoma patients in the chemotherapy only group. The median survival time for all non-small cell lung cancer (NSCLC) patients in the trial showed an increase of approximately one month for patients receiving Tavocept. This is the second Tavocept clinical trial where this pattern of survival increase has been observed. Tavocept is an investigational new drug with potential for oncology and non-oncology indications that was originated and developed by BioNumerik.

The randomized Phase II clinical trial (the "U.S. Tavocept Trial") was performed at multiple sites in the U.S. and involved 151 patients with advanced NSCLC who received the chemotherapy drugs docetaxel (sold under the brand name Taxotere^®) and cisplatin every two weeks. Approximately half of the patients received Tavocept along with chemotherapy, while the other half received chemotherapy alone... BioNumerik Pharmaceuticals' Recent Press Releases -

Advanced Life Sciences : Collaboration With UK Ministry of Defence on ALS-886

July 17, 2008 - Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS), announced that the United Kingdom's Defence Science and Technology Laboratory ("Dstl") will evaluate the developmental compound ALS-886 as a treatment for chemically induced lung injury. ALS-886 is a small molecule therapeutic that, in preclinical studies, has demonstrated efficacy in reducing and preventing tissue damage in the lungs. Dstl has experience modeling lung injury and will conduct animal efficacy studies to measure the ability of ALS-886 to improve the clinical outcome following lung injury that results from the inhalation of chemicals that damage the lung surface.
"While we remain focused on our cethromycin partnering and NDA submission activities, we have continued our efforts on the biodefense front. In this regard, we have been pleased to identify additional opportunities to advance our pipeline programs along the way. Thus, we are excited to announce that Dstl has selected ALS-886 for evaluation as a novel therapy with potential to reduce the effects that result from damage to the lung surface... Advanced Life Sciences' Press Release -

Genzyme Corporation and PTC Therapeutics : Collaboration on Small Molecule for Genetic Diseases

July 17, 2008 - Potential New Treatment Paradigm, PTC124 - Genzyme Corporation (Nasdaq: GENZ) and PTC Therapeutics, Inc. (PTC) announced an exclusive global collaboration to develop and commercialize PTC124, PTC's novel oral therapy in late-stage development for the treatment of genetic disorders due to nonsense mutations.
Under the terms of the agreement, PTC will commercialize PTC124 in the United States and Canada, and Genzyme will commercialize the treatment in all other countries. Genzyme will make an up-front payment of $100 million to PTC, plus potential milestone and royalty payments. PTC will be financially responsible for one ongoing and three additional clinical trials of PTC124, which is potentially applicable to hundreds of genetic diseases.


PTC124 is currently being evaluated in a phase 2b trial for Duchenne muscular dystrophy (DMD), and a phase 2b trial in cystic fibrosis (CF) is expected to begin by the end of this year. In its collaboration with PTC, Genzyme will draw on its expertise in genetic disorders and its strong regulatory, manufacturing and marketing infrastructure outside of the United States. Genzyme has extensive experience with cystic fibrosis, having conducted more than six clinical trials among CF patients. In the field of DMD, Genzyme's experience with Myozyme^® (alglucosidase alfa), for the treatment of the genetic disorder Pompe disease, will be directly applicable as patients with both diseases are treated by the same specialist physicians... Genzyme's Press Release - PTC Therapeutics' Press Release -

Cyclacel : study of seliciclib synergy with Tarceva and Herceptin in journal Clinical Cancer Research

July 14, 2008 – Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP) announced the publication of a study conducted by Cyclacel scientists showing synergistic activity between its investigational therapy seliciclib and multiple epidermal growth factor receptor (EGFR) inhibitors, including erlotinib (Tarceva®) in models of non-small cell lung cancer and the HER2 targeting agent, trastuzumab (Herceptin®) in models of breast cancer. These preclinical results were published in the July issue of the journal, Clinical Cancer Research. Seliciclib, Cyclacel’s orally available cyclin dependent kinase (CDK) inhibitor, is currently being tested as a single agent in the Phase 2b APPRAISE trial in patients with non-small cell lung cancer and in a Phase 2 study in patients with nasopharyngeal cancer... Cyclacel's Press Release -

Theravance : Clinical Results in the LAMA Respiratory Program for the Treatment of COPD

July 14, 2008 - Theravance, Inc. (NASDAQ: THRX) announced the results from a Phase 1 study designed to assess the safety, tolerability and pharmacokinetics of an investigational inhaled long-acting muscarinic antagonist (LAMA), GSK1160724/TD-4208 (TD-4208), for the treatment of chronic obstructive pulmonary disease (COPD). In this study, TD-4208 was generally well tolerated at all doses tested. In addition, TD-4208 showed the potential for 24-hour bronchodilation in COPD patients.

Originally discovered by Theravance, TD-4208 was licensed to GlaxoSmithKline (GSK) in 2004 under the terms of the companies' Strategic Alliance Agreement. Recently, GSK informed Theravance that it intends to return the LAMA program to Theravance because the current formulation of TD-4208 is incompatible with GSK's proprietary inhaler device.

Both parties are currently discussing the transfer of information and materials back to Theravance... Theravance's Press Release -

Mpex : Phase 2 Clinical Trial of Aerosol MP-376 in the Treatment of Chronic Bacterial Infections in Cystic Fibrosis Patients

June 25, 2008 - Mpex Pharmaceuticals, Inc. announced that it has initiated a Phase 2 clinical study with MP-376 for the treatment of pulmonary infections due to Pseudomonas aeruginosa and other bacteria in patients with cystic fibrosis. MP-376 is Mpex's proprietary aerosol formulation of levofloxacin, an antibiotic that has potent activity against key bacterial pathogens, including Pseudomonas aeruginosa. Delivery of levofloxacin directly to the lungs of CF patients by the aerosol route can potentially provide a number of safety and efficacy advantages compared to oral or IV administration.
MP-376 is delivered using a customized configuration of PARI's highly efficient eFlow® electronic nebulizer... Mpex Pharmaceuticals' Press Release -

Aradigm : Phase 2 Data with Inhaled Liposomal Ciprofloxacin for Cystic Fibrosis

June 30, 2008 - Aradigm Corporation (OTCBB:ARDM) (the Company) announced positive results from an open-label, two week efficacy and safety study of its once daily inhaled liposomal ciprofloxacin in patients with cystic fibrosis (CF). The study conducted at leading CF centers in Australia and New Zealand enrolled a total of 22 patients.
The primary efficacy endpoint in this Phase 2 study was the change from baseline in the sputum Pseudomonas Aeruginosa colony forming units (CFU), an objective measure of the reduction in pulmonary bacterial load... Aradigm's Press Release -

Novartis : strategic partnership with Lonza to accelerate growth of biologics pipeline

July 11, 2008 - Novartis announced a unique and flexible long-term partnership with Lonza, a global biotech leader in process development and manufacturing, to rapidly scale up technical development and clinical production for part of the rapidly growing Novartis biologics pipeline.

Biotechnology is a strategic focus for Novartis. Extensive research and development (R&D) activities over the past few years have resulted in a sharp increase in the number of biological compounds, currently accounting for about a quarter of the Novartis development portfolio. The Novartis Biologics unit aims to further grow the biological pipeline.

The strong Novartis R&D capabilities, coupled with Lonza's leadership in process development and manufacturing, offer an ideal platform for rapid development and production of innovative biological medicines. This may include monoclonal antibodies for treating patients with diseases such as rheumatoid arthritis, cancer, asthma and spinal cord injury... Novartis' Press Release - Lonza's Press Release -

Znomics Launches Drug Discovery Program for Treatment of Inflammatory Diseases with Leading Chemist at Oregon Health & Science University

Jul 9, 2008 - Znomics, Inc. (OTCBB:ZNOM), a pioneer in the development of the zebrafish as a vertebrate genetic platform to accelerate drug discovery, announced a collaborative research program with Oregon Health & Science University (OHSU) and Thomas Scanlan, Ph.D., Director of its Chemical Biology Program, to design and develop pre-clinical compounds to treat diseases such as rheumatoid arthritis, asthma and inflammatory bowel syndrome... Znomics' Press Release -

Icagen : Phase I Multiple Ascending Dose Clinical Trial of Senicapoc

July 9, 2008 - Icagen, Inc. (Nasdaq:ICGN) reported that the Company successfully completed the Phase I multiple ascending dose clinical trial of senicapoc, a novel orally available small molecule inhibitor of the KCa3.1 potassium ion channel, that is being developed for the treatment of asthma. Study results showed that senicapoc was well tolerated at all doses tested and in preliminary analyses exhibited predictable and dose proportional pharmacokinetics consistent with once-daily dosing. There were no serious adverse events and no dropouts from the study. Additionally, there were no dose-limiting toxicities in any subject. The Company expects to initiate a Phase II proof-of-concept clinical trial in asthma during the second half of 2008... Icagen's Press Release -

Micromet and Nycomed : Formal Preclinical Safety Studies for Antibody MT203 for Inflammatory and Autoimmune Diseases

June 24, 2008 - Micromet, Inc. (Nasdaq: MITI) and Nycomed announced the initiation of formal preclinical safety studies for the anti-GM-CSF human antibody MT203. Micromet received $775,000 (n 500,000) from Nycomed for the achievement of this milestone.
Under a 2007 agreement between the two companies, Micromet and Nycomed develop MT203, a fully human anti-GM-CSF antibody that may be useful for the treatment of various inflammatory and autoimmune diseases.

Preclinical studies support MT203's development for the treatment of rheumatoid arthritis and several other indications, including multiple sclerosis, psoriasis, asthma and chronic obstructive pulmonary disease... Micromet's Press Release -

Cell Therapeutics : Complete Study Results Comparing CTI's OPAXIO(TM) With Gemcitabine or Vinorelbine in Performance Status (PS 2) NSCLC Patients...

July 7, 2008 - Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTA) announced the publication of results from its randomized phase III trial comparing OPAXIO(TM) (paclitaxel poliglumex, CT-2103) with gemcitabine or vinorelbine for the treatment of PS 2 (performance status 2) patients with previously untreated non-small cell lung cancer (NSCLC) in the Journal of Thoracic Oncology (Volume 3, Number 7, July 2008). Results showed that overall survival was similar between the two arms (hazard ratio of 0.95; OPAXIO to control). Patients treated with OPAXIO required less supportive care including fewer red blood cell transfusions, hematopoietic growth factors, and opioid analgesics than those patients receiving either gemcitabine or vinorelbine. There were relatively few non-hematopoietic grade 3 or 4 toxicities in either arm. Additionally, patients receiving OPAXIO required fewer clinic visits due to its administration schedule, once every three weeks, and short infusion time, compared to patients receiving either gemcitabine or vinorelbine.

The objective of the study, known as STELLAR 4, was to determine if OPAXIO would improve overall survival when compared with the standard single-agent treatments of gemcitabine or vinorelbine in PS 2 patients with advanced NSCLC who had not previously received chemotherapy. The trial did not meet the primary endpoint. Secondary objectives of the study included measuring the efficacy and safety of the treatments. OPAXIO did demonstrate similar overall survival and a reduction in the supportive care required by patients... Cell Therapeutics' Press Release -