CytRx Announces Favorable Initial Results from its Ongoing Phase 1b/2 Clinical Trial in Patients with Soft Tissue Sarcomas

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced favorable response and safety indications from a group of patients with advanced solid tumors (principally soft tissue sarcomas) in the Company's ongoing Phase 1b/2 clinical trial with INNO-206, its tumor-targeting conjugate of the commonly used chemotherapeutic agent doxorubicin. Patients in this portion of the Phase 1b/2 clinical trial received three different dose levels of INNO-206 to determine its maximum tolerated dose.

In the initial Phase 1b portion of the clinical trial, 12 patients, primarily with advanced soft tissue sarcomas, have received one or more administrations of treatment with INNO-206 in three-week cycles. The Company determined a maximum tolerated dose of INNO-206 that delivers a doxorubicin equivalent of 3½ times the standard doxorubicin dose administered to sarcoma patients. CytRx is currently enrolling additional patients who will be treated at that dose to gather further response data in parallel with the planned international Phase 2b clinical trial scheduled to start this quarter.

Of five patients who have completed four cycles with INNO-206 at the maximum tolerated dose, one patient has exhibited a partial tumor response (greater than 30% tumor shrinkage) and four patients have stable disease. Unexpectedly, a large, painful oral sarcoma that caused difficulty eating in one patient was greatly reduced following a single INNO-206 treatment. Common side effects reported to date from the Phase 1b/2 trial include low neutrophil (white blood cell) and platelet counts, minor mouth ulcers and mild nausea, which are expected side effects of doxorubicin.

"Initial data of response and safety from INNO-206 in this portion of the Phase 1b/2 trial are very important," said CytRx President and CEO Steven A. Kriegsman. "Although these initial results are from a limited number of patients, the individuals treated were very advanced in their disease and had previously received multiple different chemotherapy agents, including doxorubicin, so we are pleasantly surprised to observe stable disease, much less tumor shrinkage, in these cancer patients. We believe these early indications bode well for the potential success of our international Phase 2b clinical trial in patients who have advanced disease but were not previously administered chemotherapy."

"The response from this small group of patients treated with INNO-206 is encouraging and we look forward to sharing the full, final data from the Phase 1b/2 clinical trial in a presentation at ASCO 2012," said Sant P. Chawla, M.D., F.R.A.C.P. The Phase 1b/2 clinical trial is being conducted at the Sarcoma Oncology Center in Santa Monica, Calif. under the direction of Dr. Chawla, a world-renowned expert in soft tissue sarcoma treatment who has evaluated most chemotherapies being tested in this indication.

In September 2011, CytRx announced completion of the maximum tolerated dose portion of the Phase 1b/2 trial, which included 12 patients. The patients from the early portion of the trial were evaluated for tumor response after four cycles of INNO-206. The Company also announced plans to add 12 patients to the Phase 1b/2 trial to receive INNO-206 at the maximum tolerated dose, and six of those additional patients have already been enrolled.

About INNO-206

INNO-206 is a novel conjugate of doxorubicin that binds covalently to albumin, the most abundant protein in blood plasma, and is circulated throughout the body. Doxorubicin is a standard chemotherapeutic treatment for a variety of cancers and is used either alone or in combination with other chemotherapy agents. INNO-206 is designed with a linker that releases doxorubicin in the low pH environment of tumors, concentrating the chemotherapeutic agent where it preferentially damages the tumor while minimizing the effect on healthy tissues. This conjugate formulation has the potential to safely deliver greater amounts of doxorubicin directly to the tumor compared with standard doxorubicin treatment, which could lead to improved efficacy.

CytRx holds the exclusive worldwide rights to INNO-206 -- a platform technology designed to reduce adverse events by controlling drug release and preferentially targeting tumors. In addition to doxorubicin, several other chemotherapy agents have been attached to the linker used for INNO-206, including paclitaxel, cisplatin and methotrexate, and may be incorporated into future clinical development by the Company.

About Advanced Soft Tissue Sarcomas

Patients with advanced soft tissue sarcomas who can no longer be treated with surgery have a poor prognosis and limited options. Progression-free survival for patients with advanced soft tissue sarcomas is around six to seven months, and median overall survival is approximately 18 months with less than one-third of these patients living past three years. Combinations of the chemotherapy drugs ifosfamide and doxorubicin appear to offer the highest response rates and longest time to progression in these patients; however, these regimens have not significantly improved survival and are quite toxic.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development oncology company engaged in the development of high-value human therapeutics. The CytRx oncology pipeline includes three programs in clinical development for cancer indications: INNO-206, tamibarotene and bafetinib. With its tumor-targeted doxorubicin conjugate INNO-206, CytRx plans to initiate a Phase 2b clinical trial as a treatment for soft tissue sarcomas in 2011, following its Phase 1b/2 clinical trial. The Company is evaluating bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL) and the PROACT Phase 2 clinical trial in advanced prostate cancer. CytRx's pipeline also includes tamibarotene, which it is testing in a double-blind, placebo-controlled Phase 2 clinical trial in patients with non-small-cell lung cancer, and which is in a registration clinical trial as a treatment for acute promyelocytic leukemia (APL). For more information on the Company, visit http://www.cytrx.com.

Workshop on ‘Scientific Research and Scientific Communication’

There are no shortcuts for learning some of the essential topics in the basic principles and methodologies of biomedical research. You learn these fundamentals from either experienced researchers or by attending a workshop dedicated to this theme. As in previous years, we have organized a workshop on ‘The Basic Concepts of Scientific Research and Scientific Communication’.   

This is a preconference workshop sponsored by the 63^rd Indian Pharmaceutical Congress, which is meeting in Bengaluru from 16^th to 18^th December 2011. The workshop is scheduled for the14 and 15 December in Bengaluru.  Please download a copy of the brochure and registration form at the conference websites (http://www.ipc-2011.com/;   http://www.scientificipca.org/ ). A PDF copy of the brochure from the website is also attached to this email. Space is limited, so register soon to get the subject of your choice. The ‘Writing a research protocol session’ will be held separately for each of the 5 subjects in pharmacy. Note that we have allotted more time for statistics. The theory session will be conducted in two groups, lasting 150 min each.

 

I am sure those of you who keep asking questions on fundamental aspects of research such as research topics, review of literature, how to seek a reference for a drug/method, data analysis, statistical procedure, scientific writing, poster presentation, publication, and etc., will seriously consider registering for this workshop.

The Midas touch: The success (and quality) of our research work depends not on whether or not we have sophisticated equipments at our disposal, but on how we think through the research problem (creativity and critical thinking, ideas and logics in research).

Workshop dates: 14 and 15 December 2011

Venue: Al-Ameen College Of Pharmacy, Hosur Road, (Near Lalbagh Main Gate), Bengaluru- 560 027, Karnataka

Conveners: Dr. G. Jagadeesh, US FDA, Silver spring, MD, USA

Dr. M. N. Inamdar, Al-Ameen College Of Pharmacy, Bengaluru, India

GSK joins WIPO Re:Search open innovation platform as part of its commitment to tackling diseases of the developing world

 GlaxoSmithKline (GSK) today announced it has joined WIPO Re:Search as part of its open innovation strategy to help accelerate the development of new and better treatments against neglected tropical diseases (NTDs) which affect more than a billion people in the world’s poorest countries each year.
WIPO Re:Search is a collaboration of private and public sector organisations sponsored by the World Intellectual Property Organization (WIPO) in collaboration with BIO Ventures for Global Health (BVGH). By providing a searchable, public database of available compounds, resources, expertise, and knowledge to the global health research community, this new collaboration aims to accelerate R&D into new medicines, vaccine and diagnostics to tackle the 17 NTDs listed by the World Health Organisation (WHO) such as dengue, rabies and Chagas disease as well as malaria and tuberculosis.
GSK will contribute patents and patent applications to WIPO Re:Search covering small molecules and formulations directed at developing treatments and delivery technologies for NTDs as well as its full anti-malarial dataset which includes 13,500 compounds which in screening have shown evidence of activity against malaria.
Duncan Learmouth, Senior Vice President, Developing Countries and Market Access operating unit, GSK said: “This new partnership marks an important new step forward in collaboration among these groups to reduce the hurdles to spur innovation, help develop new treatments and make a real difference to people in developing countries. A challenge on this scale requires industry, academia, NGOs and governments to work in partnership to develop new tools and approaches.”
Today’s announcements add to a number of GSK initiatives aimed at reducing the burden of diseases of the developing world, including: 

• Tres Cantos Open Lab, where researchers from external organisations and academic centres work in GSK’s dedicated diseases of the developing world drug discovery centre in Spain. So far, eight scientists from six research organisations have worked on projects at the campus. Among the projects underway are research to identify and optimise compounds that could be tested in humans against multi-drug resistant TB, three separate projects into malaria, including one that investigates potential compounds from the GSK chemical library, and a new approach against the parasites that can cause leishmaniasis.
• A dedicated R&D group focused on diseases of the developing world and NTDs including bacterial meningitis, Chagas disease, chlamydia, dengue fever, HIV/AIDS, human African trypanosomiasis, leishmaniasis, malaria, pandemic flu, pneumococcal disease and TB.
• Investment in vaccine research against diseases of the developing world. GSK has been working on a malaria vaccine for more than two decades. Positive results from the phase III study of GSK’s candidate vaccine, RTS,S, being developed in partnership with the PATH Malaria Vaccine Initiative (MVI), were announced last week.
• The creation of the Developing Countries and Market Access (DCMA) unit in 2010 to expand access to GSK medicines for the approximately 700 million people living in the 48 least developed countries (LDCs), over half of whom survive on less than US$1 a day. In LDCs, GSK caps the prices of GSK patented medicines and vaccines at no more than 25% of developed world prices and reinvests 20% of profits back into projects that strengthen healthcare infrastructure in these countries.
• Donation of over two billion albendazole tablets to the WHO to help stop transmission of lymphatic filariasis in over 50 countries. In 2011, GSK formalised a commitment with WHO to expand its donation of albendazole by 400 million tablets to treat school age children at risk of soil-transmitted helminths .
• A long-standing tiered pricing policy for vaccines which enables poorer countries to pay significantly less than higher income countries for the same vaccine with the lowest prices for agencies such as UNICEF which purchase large volumes of vaccines for the world’s poorest children. GSK vaccines are included in immunisation campaigns in 182 countries worldwide and 1.4 billion vaccine doses were delivered in 2010, of which nearly 1 billion were shipped for use in developing countries.
• Vaccine partnerships that help to build local healthcare infrastructure and manufacturing capacity, including technology transfer. As part of an agreement with Brazil’s Oswaldo Cruz Foundation (Fiocruz) to develop and manufacture vaccines for pressing public health priorities in Brazil, GSK has established an R&D collaboration programme at Fiocruz to develop a vaccine for dengue fever. 

GSK delivers strong Q3 performance with underlying sales growth of 6% and reported sales growth of 3%

GSK’s strategic priorities
GSK has focused its business around the delivery of three strategic priorities, which aim to increase growth,
reduce risk and improve GSK’s long-term financial performance:
• Grow a diversified global business
• Deliver more products of value
• Simplify GSK’s operating model


Total Group turnover for Q3 2011 increased 3% to £7,104 million, with Pharmaceuticals and Vaccines turnover up 3% to £5,775 million (Pharmaceuticals up 1% to £4,633 million and Vaccines up 14% to £1,142 million). Consumer Healthcare sales increased 5% to £1,329 million.


GSK’s late-stage Pharmaceuticals and Vaccines pipeline
There were several news events for late-stage pipeline assets in this quarter and these are listed in the table
below. On the regulatory side, Horizant was filed with the FDA for post-herpetic neuralgia and GSK received a second complete response letter for Menhibrix. Also, data on IPX066 (Parkinson’s disease), Promacta in Hepatitis C and RTS,S were received in the quarter, and recruitment was completed in a variety of studies.

In February 2011, the following 15 assets were listed as expected to deliver Phase III data by the end of 2012: 1120212, 2118436, 2402968, 642444+573719, albiglutide, dolutegravir (1349572), IPX066, MAGE-A3 (event driven), migalastat HCl, RTS,S, otelixizumab, Promacta, Relovair, Tykerb, Votrient. Phase III data were announced from studies on IPX066, otelixizumab and Votrient in Q1 and Promacta and Relovair in Q2.

Data were announced in Q3 from the final pivotal study for IPX066, a head-to-head study versus Stalevo in
Parkinson’s disease (ASCEND). Additionally, the first data were announced from the Phase III study of Mosquirix for malaria prophylaxis in 5-17 month old children. Of the 15 assets with data expected by the end of 2012, six have now reported data. Of these, data have been filed for Votrient in sarcoma, data is in-house and being reviewed for Promacta (Hepatitis C) and IPX066 in Parkinson’s disease and programmes are ongoing for Relovair and RTS,S. One study, with otelixizumab, failed to show efficacy. Overall, by the end of 2012 GSK expects more than 30 further Phase III read-outs on the ongoing assets.

Novartis achieves strong third quarter financial performance and pipeline progress

• Novartis sales rose 12% and core operating income grew 15% in constant currencies in the third quarter, delivering operating leverage

• Net sales increased 18% (+12% in constant currencies, or cc) to USD 14.8 billion; nine months up 20% (+15% cc) to USD 43.8 billion

• Core operating income grew 11% (+15% cc) to USD 4.1 billion; core margin of 27.7% up 0.6 percentage points in cc; nine months core margin of 28.2% up 0.5 percentage points in cc

• Core EPS advanced 7% to USD 1.45 (+10% cc) from USD 1.36 in previous-year period

• Free cash flow grew 27% to USD 3.7 billion

• Industry-leading pipeline results in new approvals, further expanding our ability to meet patient needs and sustain growth long-term

• In the EU, Afinitor/Votubia was approved for two additional indications; positive CHMP opinion was granted for Rasitrio for high blood pressure

• Gilenya, our breakthrough multiple sclerosis treatment, won approval in Japan

• Pivotal Phase III study of Afinitor plus exemestane demonstrates that the treatment significantly lengthens the amount of time women with advanced breast cancer live without the disease progressing

• Novartis to take further action to improve productivity and to absorb pricing pressures

• Novartis is announcing today additional cost reduction activity, which will be executed over three to five years. Elements of the activity to include: reallocation of production within the Novartis network resulting in closure of two sites in Switzerland and one in Italy; restructuring the development organization largely in Switzerland and the US and relocating some research activities from Switzerland to the US

• In total, approximately 2,000 positions will be reduced in the Group, subject to required employee consultation, mostly in Switzerland and the US offset by 700 new positions in low cost and other countries. 

Affymax Announces FDA Advisory Committee to Review Peginesatide

Oncologic Drugs Advisory Committee Meeting Scheduled for December 7, 2011

PALO ALTO, Calif.--(BUSINESS WIRE)-- Affymax, Inc. (Nasdaq:AFFY) today announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will review the New Drug Application (NDA) for peginesatide proposed for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis on December 7, 2011 during the afternoon session. The FDA has established an action date of March 27, 2012 under the Prescription Drug User Fee Act (PDUFA).

Erythropoiesis stimulating agents (ESAs) are reviewed by the Office of Hematology and Oncology Products (OHOP). As such, FDA has designated ODAC for the review of peginesatide. Information related to the meeting can be found on the U.S. Office of the Federal Register Website at: http://www.fda.gov/RegulatoryInformation/Dockets/FR/default.htm.

The company intends to begin a self-imposed quiet period on November 16, 2011 in anticipation of receipt of FDA briefing documents, and this quiet period will continue until after the Advisory Committee meeting is completed.

If approved, peginesatide will be the first once-monthly ESA available for the treatment of anemia associated with CKD patients on dialysis in the United States.

Peginesatide is a synthetic, PEGylated peptidic compound that binds to and stimulates the erythropoietin receptor and thus acts as an ESA. The NDA included data from two Phase 3 studies (EMERALD 1 and 2) that evaluated the efficacy and safety of peginesatide, dosed once every four weeks, compared to epoetin alfa or epoetin beta, dosed more frequently (according to the product labels) in maintaining hemoglobin (Hb) levels in CKD patients on dialysis with anemia. In the studies, over 1,600 CKD patients on dialysis who were receiving stable doses of epoetin were randomized to receive once-monthly peginesatide or continue treatment with epoetin. The EMERALD findings suggested that once-monthly peginesatide was comparable to epoetin in maintaining Hb levels in CKD patients on dialysis with anemia with a similar adverse event rate. The most common adverse events reported in the clinical studies were diarrhea, cough, dyspnea, nausea, and muscle spasm. A similar frequency of serious adverse events was reported between the EMERALD treatment groups.

About Peginesatide

Affymax and Takeda are collaborating on the development of peginesatide and plan to co-commercialize the product if approved in the United States. Takeda has exclusive rights to develop and commercialize the product outside the United States. The peginesatide Phase 3 clinical program was the largest to support the registration of an ESA for the treatment of anemia in CKD and the first to prospectively evaluate the cardiovascular safety of an ESA via an analysis of independently adjudicated cardiovascular events.

About Anemia in Chronic Kidney Disease

Anemia is a common complication in CKD, because the impaired kidneys are not able to produce enough erythropoietin, the hormone that promotes the production of oxygen-carrying red blood cells. Research has shown that anemia impacts the overall health and well being of CKD and dialysis patients and is associated with increased rates of hospitalization and mortality. In severe or prolonged cases of anemia, the lack of oxygen in the blood can cause serious and sometimes fatal damage to the heart and other organs.

ESAs, which stimulate red blood cell production, are commonly prescribed to treat anemia of CKD. According to the Centers for Medicare and Medicaid Services, more than 95 percent of patients on dialysis in the U.S. are currently receiving ESA treatment for anemia of CKD.      

Pharma cos in north India focus on advanced R&D services

Indian pharmaceutical industry has long focused on the sales of its low-cost generics in high volumes thereby resulting in limited expenditure in R&D. But there are certain north based Indian pharma companies that are breaking the mould by inventing novel research product, according to Pawan Chaudhary, CMD, Venus Remedies Limited.

In a discussion on the prospects of the pharma enterprises in north India, Chaudhary said that the industry in the region spanning from Punjab to Uttar Pradesh has offered compelling advantages which cannot be ignored. The pharma industry in north India is dominated by listed companies like Ranbaxy Laboratories, Jubilant Organosys, Surya Pharma, Nectar Lifesciences, Panacea Biotec, Ind-Swift Group, Fresenius Kabi Oncology the erstwhile Dabur Pharma, Jagsonpal Pharma and Venus Remedies. These companies have invested in high-tech R&D laboratories which are US FDA approved facilities with strategic tie-ups and looking at massive expansion and investments for new technologies, he said.

Post 2005, the Union government identified the excise free zones and in the last few years, these hubs now sans tax benefits. But in the Union Budget 2010-11 sops like the weighted deduction for in-house R&D increasing from 150 per cent to 200 per cent, is viewed to reduce the tax liability of drug companies, leading to enhanced plough-back of profits. Moreover, the government has also plans to create a Rs.3,000 crore pharmaceutical fund to promote innovative drug discovery like biologics. These moves are exceptionally gratifying, stated the Venus Remedies CMD.

The contract manufacturer initiative in India is on the rise with increasing number of US companies opting out for outsourcing R&D and manufacturing to reduce operating expenses. Himachal Pradesh being the excise free zone offers a conducive environment to the pharmaceutical players to grow well. Moreover, the contract manufacturing is a profitable business that allows a company to have multiple customers, they produce for with reduced costs in acquiring the raw material and zero marketing expense to promote the brand. 

source: Pharmabiz

ICT with DPST & UGC-CAS to organise 2-day symposia on nanomedicine

Institute of Chemical Technology (ICT), Mumbai in collaboration with the Department of Pharmaceutical Sciences and Technology (DPST) and the UGC Centre of Advanced Studies (UGC-CAS) is organising a two day Indo-US joint symposia on nanomedicine: Its prospects and challenges from November 14 – 15, 2011 at ICT campus.

Nanomedicine, is a concept originated from India. In Ayurveda, the use of Bhasmas is still popular which is a form of nanomedicine. The modern medicine has realized the potential of nanomedicine to reduce the dose, toxicity and for its targeting potential worldwide.

The nanomedicine is used for diagnostics and therapeutics of cancer, neurodegeneratives, tuberculosis, malaria and other infectious diseases is established and a thrust area of research. Many nanotechnology products based on immunomodulator formulations are in clinical use.

Prof Vandana B Patravale, professor of pharmaceutics, DPST and ICT, Mumbai said that this will be the first time where India and US will come together and this collaboration is expected to foster between the US and Indian investigators and it will be academia-academia, industry-industry collaboration.

“It will be beneficial for Indian consumers as the high end technologies could be identified with drug delivery systems, and devices. This could be the key feature to drive growth of pharmaceutical and medical sectors into cost effective, patient compliant, safe yet superior products for Indian market,” further she added.

This symposia will target biomedical engineers, pharmaceutical and clinical researchers, clinicians as well as graduate and post doctorate fellows and research scientists from both academia and industry who have an interest in nanomedicine and its potential to improve patient care.

source: Pharmabiz

Merck's combo pill Juvisync gets US FDA nod

Merck & Co. have announced that the US FDA have approved Juvisync (sitagliptin and simvastatin), a fixed-dose combination (FDC) prescription medication that contains two previously approved medicines in one tablet for use in adults who need both sitagliptin and simvastatin.

Sitagliptin is a dipeptidyl peptidase 4 (DPP-4) inhibitor that enhances the body's own ability to lower elevated blood sugar and is approved for use in combination with diet and exercise to improve glycemic control in adults with type 2 diabetes. Simvastatin is an HMG-CoA reductase inhibitor, or statin, approved for use with diet and exercise to reduce the amount of "bad cholesterol" (low-density lipoprotein cholesterol or LDL-C) in the blood.

This FDC is based on substantial experience with both sitagliptin and simvastatin, and the ability of the single tablet to deliver similar amounts of the drugs to the bloodstream as when sitagliptin and simvastatin are taken separately. Juvisync is a convenience combination and should only be prescribed when it is appropriate for a patient to be placed on both of these drugs.

Juvisync was approved in dosage strengths for sitagliptin/simvastatin of 100 mg/10 mg, 100 mg/20 mg and 100 mg/40 mg. The company have committed to develop FDC tablets with the sitagliptin 50 mg dose, as Juvisync 50 mg/10 mg, 50 mg/20 mg and 50 mg/40 mg. Pending availability of the FDC tablets containing 50 mg of sitagliptin, patients who require this dose should continue to use the single ingredient sitagliptin tablet. There is no plan to develop FDCs with the sitagliptin 25 mg dose as use of this dose is quite low.

Simvastatin is currently marketed in dosage strengths of 5, 10, 20, 40, and 80 mg. Due to recent restrictions placed on the use of the 80 mg dose because of a higher risk of muscle toxicity, there will not be a FDC using this dose. Merck does not plan to develop FDCs with the simvastatin 5 mg dose as use of this dose is quite low as well. 

Click here to read the approval letter.