Pharma company Strides Arcolab unit Onco Therapies has received US Food and Drugs Administration (FDA) approval for Paclitaxel injection used to treat ovarian cancer, breast cancer and non-small cell lung cancer.

Onco Therapies also received tentative approval for Oxaliplatin injection, another chemotherapy drug used to treat cancer of the colon and rectum, Strides Arcolab said Friday.

By Charles Bankhead, Staff Writer, MedPage Today

STOCKHOLM — Patients with non-small cell lung cancer (NSCLC) had a 50% reduction in the progression hazard with a three-drug first-line chemotherapy regimen followed by a two-drug maintenance regimen, results of an international study showed.

Patients had a median progression-free survival of 10.2 months when treated with cisplatin, pemetrexed (Alimta), and bevacizumab (Avastin), followed by maintenance therapy with pemetrexed and bevacizumab.

Those who received the same upfront therapy and maintenance with bevacizumab alone had a median progression-free survival of 6.6 months, Fabrice Barlesi, MD, reported here at the European Multidisciplinary Cancer Congress, formerly the Congress of the European Cancer Organization and European Society for Medical Oncology.

MILAN, ITALY, Sep 27, 2011 (MARKETWIRE via COMTEX) — MolMed S.p.A. (milan:MLM) presented new data from four clinical trials on its investigational anticancer drug NGR-hTNF at the European Multidisciplinary Cancer Congress, taking place in Stockholm on 23-27 September 2011. The Company reported updated interim results from a randomised Phase II trial in non-small-cell lung cancer, and follow-up data from two completed Phase II trials in recurrent ovarian cancer and relapsed small-cell lung cancer. The clinical development update also included results from a Phase I trial at high doses.

Claudio Bordignon, chairman and CEO of MolMed, comments: “The new interim randomised data in lung cancer look promising particularly in patients with the squamous cell histological subtype, a severe form of lung cancer with high need of new treatment options. As to new follow-up data from the two completed trials, the long-term clinical benefit in two poor-prognosis tumours such as relapsed ovarian and small-cell lung cancer, observed in patients presenting normal lymphocyte counts, confirms the dual mode by which NGR-hTNF exerts its effect, destroying the tumour vasculature and exploiting the effectors of the immune system. There is a growing need for tools, among which predictive biomarkers, to identify patients responding to a specific drug: for NGR-hTNF, a simple blood test such as lymphocyte counts correlates with clinical benefit. This parameter, together with others, might contribute in the future to the identification of patients more likely to get prolonged therapeutic benefit.”

Centers Worldwide Evaluate Real-Time Tumor Tracking Technology During Lung Cancer Radiotherapy

SEATTLE, WA, Sep 27, 2011 (MARKETWIRE via COMTEX) — Calypso Medical Technologies, Inc., developer of real-time localization technology used for precise tumor tracking, announced that the U.S. Food and Drug Administration (FDA) granted Investigational Device Exemption (IDE) approval for its clinical study evaluating real-time tracking of lung cancer tumors during radiation delivery. Patient enrollment is planned at Washington University in St. Louis, and the Cancer Treatment Centers of America in Tulsa, Oklahoma. Investigators in the United States will implant three anchored Beacon(R) transponders in patients’ lungs and use the Calypso(R) System to precisely track tumor location and movement during lung cancer radiation therapy.

“We are very pleased to see Calypso begin the U.S. portion of this important clinical study to assess the clinical experience and safety of anchored transponders in the small airways of patients with lung cancer,” said Daniel Nader, DO, FCCP, national clinical director, pulmonary/critical care and interventional pulmonologist at the Cancer Treatment Centers of America at Southwestern Regional Medical Center in Tulsa, Okla. “The five-year survival rate for lung cancer is grim at just 16 percent; however, with the Calypso System’s ability to track this high-velocity repetitive motion, treatment options for lung cancer patients may expand to include earlier and more aggressive radiation treatment.”

STOCKHOLM, SWEDEN – September 26, 2011. Axelar AB, a Karolinska Development AB portfolio company, today releases results of the completed Phase I/II clinical safety study for its drug candidate AXL1717 at the European Multidisciplinary Cancer Congress (ESMO) meeting in Stockholm, Sweden. All major objectives were met in the study and signs that suggest clinical benefit were observed in some patients with non-small cell lung cancer.

AXL1717 is the first targeted oral small-molecule Insulin-like Growth Factor 1 (IGF-1) receptor inhibitor clinically tested which does not affect the closely-related insulin receptor. The drug was administered to a total of 49 advanced-stage cancer patients with progressive solid tumors who had no remaining treatment options. The main purpose of the study was to investigate the safety profile of AXL1717. The open label study consisted of three parts: a single day twice-daily ascending dose part, a 7-28 days twice-daily dose-finding part, and an extension part at a fixed twice-daily dose for 28 days in two cycles 14 days apart.

Amsterdam, The Netherlands: A new type of diagnostic imaging – which can better differentiate benign lung lesions from those which are cancerous – could be used to prevent unnecessary surgery by enabling more accurate diagnosis of the disease.

A study by Belgian researchers, which will be presented today (25 September 2011) at the European Respiratory Society’s Annual Congress in Amsterdam, found that the new technique can more accurately determine whether people have the disease when compared with the current method of PET-CT scans.

Avastin and pemetrexed combination gives lung cancer patients significantly more time without their disease progressing

New Roche study in non-small cell lung cancer confirms importance of maintenance treatment

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that AVAPERL, a phase III study evaluating the combination of Avastin® (bevacizumab) and chemotherapy for patients with previously untreated, advanced non-squamous non-small cell lung cancer (NSCLC) met its primary endpoint, giving lung cancer patients significantly more time without their disease progressing. The results will be presented for the first time today at the European Multidisciplinary Cancer Congress in Stockholm.

In AVAPERL, previously untreated NSCLC patients were given four cycles of Avastin, pemetrexed and cisplatin. Those patients whose disease was controlled (i.e. did not progress) continued treatment with Avastin and pemetrexed and lived for a median of 10.2 months without their disease getting worse (progression-free survival; PFS). In the control arm, those patients who continued Avastin alone demonstrated a median PFS of 6.6 months (HR=0.50; p>0.001). No new safety events were observed and adverse events in AVAPERL were consistent with those observed in previous Avastin and pemetrexed clinical trials.

CAMBRIDGE, Mass., Sep 21, 2011 (BUSINESS WIRE) — ARIAD Pharmaceuticals, Inc. ARIA +0.39% today announced the start of patient dosing in an international Phase 1/2 clinical trial of AP26113, an investigational dual inhibitor of anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR) — two clinically validated targets in non-small cell lung cancer (NSCLC). AP26113 is the third novel, small-molecule drug candidate for the treatment of cancer that was discovered by ARIAD scientists and has advanced into clinical development.

The initial Phase 1 dose-escalation trial will include patients with advanced solid tumors, particularly those with NSCLC. Patients enrolled in this multicenter study will be either refractory to available therapies or have no standard treatment available to them. The primary objective of the Phase 1 segment of the Phase 1/2 trial is to determine the initial safety, tolerability, pharmacokinetic profile, recommended dose (anticipated to be once daily), and preliminary anti-tumor activity of AP26113. ARIAD expects to enroll approximately 30 to 50 patients in this portion of the trial.

If a tumor is more visible and easier to distinguish from surrounding tissues, surgeons will be more likely to be able to remove it completely. That’s the rationale behind a new $7 million, five-year “transformative” grant from the National Institutes of Health to a team of researchers from Emory, Georgia Tech and the Perelman School of Medicine at the University of Pennsylvania.

The grant is part of the NIH Director’s Awards Program funded by the NIH Common Fund.

Shuming Nie, PhD, and his colleagues at the Emory-Georgia Tech Nanotechnology Center for Personalized and Predictive Oncology have been developing fluorescent nanoparticle probes that hone in on cancer cells. The grant will support the team’s continuing work on the nanoparticles and instruments that visualize them for cancer detection during surgery.

From rdmag.com

GE Reports: How else does multiplexing technology help with cancer diagnostics?

Dr. Burczak: Clarient has developed some molecular pathology tests that look at many different proteins. One such test, called Pulmotype, determines what type of lung cancer a patient has. One of the big problems with lung biopsies is the difficulty in obtaining enough tissue because the physician cannot remove a large section of lung. With the GE multiplexing technology, even with very small amounts of tissue, Clarient can run their whole Pulmotype test and get a complete analysis.