bowonwing
15年前
Hi surf! got MEDX (not me)? Bristol-Myers to buy Medarex for $16 a share cash
LOS ANGELES (MarketWatch) -- Bristol-Myers Squibb Co. (BMY 20.53, +0.24, +1.18%) has signed a deal to buy biopharmaceutical firm Medarex Inc. (MEDX 15.98, +7.58, +90.24%) for $16.00 per share in cash, almost double their Wednesday close, resulting in an aggregate purchase price of about $2.4 billion, the two companies said in a statement late Wednesday. Medarex's projected $300 million in net cash and marketable securities at the close of the deal would knock the final price down to $2.1 billion. Among the properties acquired in the merger is ipilimumab, a novel immunotherapy currently in Phase III development for the treatment of metastatic melanoma, which Bristol-Myers said could be "an important contributor to [its] future growth." The tender for the shares will begin on or about July 27, with the deal expected to close 30 days later, pending regulatory approval. Shares of Bristol-Myers closed up 0.9% at $20.29 Wendesday, while those of Medarex were up 1.45% at $8.40. The announcement comes one day before Bristol-Myers is slated to announce its financial results for the second quarter.
surf1944
16年前
Medarex to Present at Three Upcoming Investor Conferences
On Wednesday June 3, 2009, 4:00 pm EDT
PRINCETON, N.J.--(BUSINESS WIRE)--Medarex, Inc. (NASDAQ:MEDX - News) announced today that it is scheduled to present at the following three conferences:
Goldman Sachs 30th Annual Global Healthcare Conference
June 9, 2009 at 3:10 p.m. Eastern Time
Needham Life Sciences Conference
June 11, 2009 at 2:00 p.m. Eastern Time
Jefferies 3rd Annual Healthcare Conference
June 17, 2009 at 11:15 a.m. Eastern Time
These events will be webcast live and will be available in the Investor Relations section of the Medarex website at www.medarex.com. An archived edition of the presentation will be available following the event.
About Medarex
Medarex is a biopharmaceutical company focused on the discovery, development and potential commercialization of fully human antibody-based therapeutics to treat life-threatening and debilitating diseases, including cancer, inflammation, autoimmune disorders and infectious diseases. Medarex applies its UltiMAb® technology and product development and clinical manufacturing experience to generate, support and potentially commercialize a broad range of fully human antibody product candidates for itself and its partners. Over forty of these therapeutic product candidates derived from Medarex technology are in human clinical testing or have had INDs submitted for such trials, with the most advanced product candidates currently approved for commercial sale, the subject of regulatory applications for marketing authorization or in Phase 3 clinical trials. Medarex is committed to building value by developing a diverse pipeline of antibody products to address the world’s unmet healthcare needs. For more information about Medarex, visit its website at www.medarex.com.
surf1944
16年前
Medarex Announces Efficacy Data in Cancer Patients Treated with Investigational Anti-PD-1 Antibody at American Society of Clinical Oncology Annual Meeting
-Phase 1 Single-Dose and Phase 1b Multi-Dose Data Presented-
On Monday June 1, 2009, 8:00 am EDT
PRINCETON, N.J.--(BUSINESS WIRE)--Medarex, Inc. (NASDAQ: MEDX - News) today announced anti-tumor activity and efficacy data for MDX-1106 (also known as ONO-4538), a fully human anti-PD-1 antibody that Medarex is co-developing with Ono Pharmaceutical Co. Ltd. for the treatment of recurrent or treatment-refractory cancers, including malignant melanoma, renal cell carcinoma, colorectal carcinoma, non-small cell lung cancer, and castrate resistant prostate carcinoma. Results presented at the annual meeting of the American Society of Clinical Oncology (ASCO) showed:
Durable anti-tumor activity in patients treated with intermittent 10 mg/kg dosing of MDX-1106 in the 21-patient expansion cohort from the Phase 1 trial, including one patient with renal cell cancer experiencing an ongoing objective partial response of over 9 months and one patient with melanoma experiencing ongoing stable disease with marked clinical improvement for over 19 months and 9 doses of MDX-1106. One patient with colorectal carcinoma treated with five doses at the earlier 3 mg/kg cohort has also maintained a partial response for over 20 months;
All patients showing clinical benefit with MDX-1106 had previously progressed after prior chemotherapies;
None of the patients treated at 10 mg/kg have developed any significant drug-related adverse events. MDX-1106 appeared to be well-tolerated at the 10 mg/kg dose, including those patients in the cohort eligible to receive between two and nine doses of 10mg/kg MDX-1106; and
No dose-limiting toxicities have been reached.
These data focused on the experience of an expansion cohort of 21 patients dosed at 10 mg/kg of MDX-1106 from the single-dose Phase 1 trial and were presented by investigator Julie Brahmer, M.D., Assistant Professor of Oncology from the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University (Abstract #3018). The complete study was designed to examine the safety, tolerability and pharmacokinetic profile of single-dose MDX-1106 (0.3, 1, 3 or 10 mg/kg) in patients with recurrent or treatment-refractory cancers. However, per protocol, patients demonstrating clinical benefit could receive additional intermittent doses (up to nine doses of 10 mg/kg MDX-1106) until an objective response was obtained. In addition to the durable responses outlined above, lesional regressions were observed in two additional patients, including one with non-small cell lung cancer, and one with melanoma. Enrollment in the single-dose Phase 1 trial is complete with 39 patients.
Also presented were preliminary data from an ongoing multi-dose, dose escalating Phase 1b monotherapy study of MDX-1106. One patient with melanoma in the first treatment cohort of 4 patients has demonstrated marked tumor regression of liver and lung lesions after receiving four doses of 1 mg/kg of MDX-1106. The tumors have continued to shrink after additional cycles of four doses, and the patient continues to tolerate the treatment without adverse events. Additional anti-tumor activity has been observed with lung lesion regression in a patient with renal cell cancer. Subsequently observed in the second dose level cohort, one patient with non-small cell lung cancer has demonstrated regression of a solitary adrenal metastasis after the first 4 doses of 3 mg/kg of MDX-1106. The trial is designed to examine the safety and activity in patients treated with multiple doses of MDX-1106 (1, 3 and 10 mg/kg) administered every two weeks until a confirmed complete response, clear progression or serious adverse event emerges. This multi-center, open label study is expected to enroll up to 76 patients in the United States.
“We are encouraged by both the safety profile and the initial anti-tumor activity that included durable responses in several cancer indications for patients treated intermittently with MDX-1106 up to the 10 mg/kg dose. We are also pleased by our ongoing Phase 1b study of repeated doses of the antibody which has also shown early evidence of activity at a repeated dose of 1 or 3 mg/kg,” said Geoffrey M. Nichol, MBChB, Senior Vice President of Product Development at Medarex. “While we are still in early stages of development, it is also exciting that these treatments continue to be generally well tolerated.”
About MDX-1106/ONO-4538
MDX-1106/ONO-4538 is a novel fully human antibody designed to target and inhibit the function of PD-1 (programmed cell death 1), a receptor expressed on the surface of activated lymphocytes (T-cells). The binding of PD-1 with one of two ligands (PD-L1 or PD-L2) is an important negative regulation pathway that suppresses or inhibits activated lymphocytes. Recent research has noted increased PD-1 expression levels on antigen specific T-cells in both the oncology and chronic infectious disease settings, as well as a strong correlation between increased PD-L1 expression on tumors and a negative survival prognosis in cancer patients. Preclinical studies indicate that antibodies targeting the PD-1 signaling pathway reinvigorate antigen-specific T-cell responses and promote an immune response to fight tumors and infectious diseases.
MDX-1106/ONO-4538 is being investigated in both the oncology and infectious disease settings. In addition to the Phase 1b study in cancer, a Phase 1 trial is ongoing for the treatment of hepatitis C. In September 2008, Ono initiated a single and multi-dose Phase 1 clinical study in patients with advanced solid malignancies in Japan. MDX-1106/ONO-4538 may also have the potential to be used synergistically in combination with other treatment modalities, including with anti-CTLA-4 blockade.
In May 2005, Ono entered into a collaboration agreement with Medarex to research and develop a fully human anti-PD-1 antibody for the treatment of cancer. The two companies plan to share the costs and responsibilities of research and product development up to the completion of a Phase 2 clinical study in each party’s territory. Thereafter, each company will be fully responsible for any continued development and any commercialization in its exclusive territory; Medarex’s exclusive territory is North America, and Ono’s exclusive territory is all areas outside of North America.
north40000
16年前
Do these mabs and pathways look familiar? I wonder who is sponsoring the research:
Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology, and Harvard, Massachusetts General Hospital, Charlestown, MA 02129, USA. dkaufmann@partners.org
The balance between proinflammatory mechanisms and the dampening of excessive immune activation is critical for successful clearance of a pathogen without harm to the host. In particular, molecules of the B7:CD28 family play a critical role in regulating T cell activation and peripheral tolerance. Chronic pathogens like HIV, which is characterized by ongoing viral replication despite detectable virus-specific T cell responses, and cancer cells have exploited these pathways to attenuate Ag-specific T cell immunity. This review summarizes evidence that molecules of the B7:CD28 family, PD-1, CTLA-4, and their ligands, play an active and reversible role in virus-specific T cell exhaustion associated with HIV infection in humans and in the SIV model in macaques. We discuss the potential for immunotherapeutic interventions based on manipulation of these inhibitory networks, the promising data obtained with blockade of the PD-1 pathway in animal models, and the challenges to such therapies.
http://www.ncbi.nlm.nih.gov/pubmed/19414738?dopt=Abstract
lidopete
16年前
Buisness Week
Marcial: Medarex, a Bright Spot in Biotech
Its drug pipeline is the envy of the industry, and financing for completing late-stage developments is healthy. Bulls think the stock could bounce some more
Medarex (MEDX)--52-week ADR price
By Gene Marcial
The world of biotechs is a tricky place for investors. Ambitious young companies aspiring to become future drug kings require huge financial resources to produce life-changing medicines that take many years to develop. Most firms never make it beyond the development stage. Nonetheless, some biotechs manage to reap enormous rewards once they reach near-commercialization of their products.
That is where Medarex (MEDX), a biopharmaceutical outfit focused on monoclonal-antibody-based therapeutics for cancer and inflammation-related diseases, appears to be headed, according to several investment pros. Medarex believes antibodies have proven to be useful elements in making drugs. Analysts note that as of December 2008, the Food & Drug Administration has approved 24 therapeutic products based on antibodies.
Medarex is one of the few biotechs that has chalked up handsome gains this year. It shot up to 6 a share on May 1, from a 52-week closing low of 3.40 on Mar. 3, 2009. On Aug. 1, 2008, the stock had been much higher, streaking to a 52-week closing high of 10.12. So the bulls are optimistic the stock could bounce up some more, to the 10 to 11 level in 12 months. The Standard & Poor's Biotech Index declined 8.7% year-to-date through Apr. 8, 2009.
The company is close to becoming a major biotech player, says analyst Mark Monane of investment bank Needham, given its late-stage development drugs aimed at major diseases, including metastatic melanoma, prostate and lung cancers, psoriasis, rheumatoid arthritis, and clostridium—a deadly form of diarrhea. (Needham has done banking for Medarex.)
Medarex's state of drug production is the envy of other biotechs. "Medarex has one of the most robust pipelines in the industry, with 40 compounds in development, either internally or through partnerships, including three that are in phase III clinical trials," says analyst Jeffrey Loo of Standard & Poor's, who rates the stock a buy. (S&P, like BusinessWeek, is a unit of The McGraw-Hill Companies (MHP).)
More Than 50 Partnerships
On Apr. 24, the FDA approved one of Medarex's products developed in partnership with Johnson & Johnson (JNJ) called "Simponi," as a once-a-month subcutaneous treatment for moderate-severe rheumatoid arthritis. In December 2008, J&J got approval from Canada to market another Medarex drug called Stelara, for treatment of severe plaque psoriasis in adults. And in January 2009, the European Commission gave its approval for the same drug. Stelara is still under review by the FDA for the U.S. market.
Medarex has been busy teaming up with some of the biggest pharmaceutical companies. Loo notes that as of Dec. 31, 2008, Medarex had more than 50 partnerships with pharmaceutical and biotech companies to jointly develop and commercialize products, including Pfizer (PFE), Amgen (AMGN), Bristol-Myers Squibb (BMY), J&J, Eli Lilly (LLY), Abbott Laboratories (ABT), Human Genome Sciences (HGSI), and Novartis (NVS).
Marcial: Medarex, a Bright Spot in Biotech
Last Apr. 21, Medarex and Massachusetts Biological Laboratories entered into a licensing agreement with Merck (MRK) to further develop the clostridium drug. Merck made a down payment of $60 million to Medarex and Massachusetts Biological for the partnership. Payments of $165 million are expected down the road as the drug meets further production milestone targets.
"The [Merck] collaboration is positive for Medarex," says Needham's Monane, given the favorable financial terms to complete the drug's phase III development and Merck's commitment to bring its infectious-disease expertise that is needed to develop the product. Bristol-Myers is Medarex's partner on its drug to treat melanoma, now in phase III clinical trials. Data from the trials are expected to be released at the end of the fourth quarter.
Copacetic for Capital
S&P's Loo notes that as of December 2008, 40 antibodies derived from Medarex's proprietary "UltiMab technology" were in human clinical trials, or had regulatory applications submitted for such trials for a wide range of diseases.
The question of money is always paramount with the biotechs. Financially, Medarex appears to be in a sound position. "It is among the best-capitalized small biotech firms," notes S&P's Loo, "with sufficient capital to fund drug development for the next 36 months."
Nonetheless, it has yet to make money. Revenue improvements probably won't offset high operating costs, particularly for research and development, says analyst Adam Rosner of independent research firm Value Line (VALU). But he notes that Medarex's finances remain adequate. It ended 2008 with some $355 million in cash and marketable securities.
He expects the company's top line to rise considerably in 2010. He notes that milestone payments and licensing fees for products in development have accounted for all of Medarex's sales. Such contributions are expected to reach about $85 million in 2010, estimates Rosner.
For investors, biotechs require a lot of patience—and ultimately, faith. The growing perception is that Medarex may be able to justify that faith.
Unless otherwise noted, neither the sources cited in Gene Marcial's Stock Picks nor their firms hold positions in the stocks under discussion. Similarly, they have no investment banking or other financial relationships with them.
Marcial writes the Inside Wall Street column for BusinessWeek. In 2008, FT Press published the book Gene Marcial's 7 Commandments of Stock Investing.
schoolmarm
16年前
Oh, yeah, I'm watching. It might retrace a bit but a lot of attention is being focused this week: substantial increase in revenues, 67% being held by institutions, large short interest, possible takeover target, high volume this week, mentioned at least twice on CNBC concerning partnerships and products, etc.
If they drop it back to the 6.17 area, might have to buy more.
surf1944
16年前
PharmAthene Presents Data for Protexia(R) and Valortim(R) at 2008 BARDA Industry Conference / PHEMCE Stakeholders Workshop
Wednesday September 24, 9:00 am ET
ANNAPOLIS, Md., Sept. 24 /PRNewswire-FirstCall/ -- PharmAthene, Inc. (Amex: PIP - News), a biodefense company developing medical countermeasures against biological and chemical threats, announced today that the Company is presenting two posters and an oral presentation on its medical countermeasures programs, Protexia® (rBChE) and Valortim® at the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Stakeholders Workshop 2008 / BARDA Industry Day being held in Alexandria, VA, September 24 - 26, 2008.
David P. Wright, President and Chief Executive Officer of PharmAthene commented, "We want to commend BARDA's new leadership for moving forward aggressively to engage with industry as a partner, and for their commitment to providing greater transparency and a long-term strategy for biodefense medical countermeasures research, development and procurement."
"We are delighted to have the opportunity to present these data at the PHEMCE conference, which is an important industry meeting for companies in the biodefense sector. As the data illustrate, PharmAthene continues to advance its pipeline and further its leadership position in biodefense by working collaboratively with the U.S. government to develop unique animal models that can potentially accelerate product commercialization," Mr. Wright continued.
Protexia®, a recombinant version of human butyrylcholinesterase (BChE), is being developed as a pre- and post-exposure therapy for casualties on the battlefield or civilian victims of nerve agent attacks. Valortim®, in co-development with Medarex, Inc., (Nasdaq: MEDX - News) is a fully human monoclonal antibody designed to treat and protect against inhalational anthrax. Highlights of the poster presentations include:
-- A study of non-pegylated recombinant BChE in a guinea pig model provides new data that suggests that the pegylated rBChE (Protexia®) may have efficacy as a therapeutic against nerve agent exposure.
-- A study of Valortim® in a primate animal model utilizing the African green monkey (AGM) shows promise as a potential therapeutic for the treatment of inhalational anthrax.
-- A summary of the Valortim® development program, including previously reported Phase I data demonstrating that Valortim® is safe and well-tolerated, with no drug-related Grade 2-4 or serious adverse events supporting the potential of Valortim® as a promising therapy for treatment and post-exposure prophylaxis for inhalational anthrax.
Summary of Data Presented:
Non-pegylated rBChE Findings Reported
In a poster entitled, "Recombinant Butyrylcholinesterase (rBChE) Therapy Following VX Poisoning by the Percutaneous Route: Preliminary Results from Guinea Pig Studies," investigators studied the effects of non-pegylated rBChE administered following poisoning by VX in an animal model which mimics percutaneous exposure. In this model, free agent was measured in both the dermis and blood enabling investigation of their temporal relationships. Non-pegylated rBChE significantly reduced the concentration of free VX in the blood. At 7.5 hours the cholinesterase activity of the plasma was approximately 27 fold greater than control. Additionally, brain cholinesterase levels were similar to previously published data from untreated controls suggesting that non-pegylated rBChE prevented the inhibition of these tissues by VX. The reduced concentration of circulating free VX following poisoning by the percutaneous route in animals treated with non-pegylated rBChE supports the conclusions of an earlier study (Mikler et al, 2007) that rBChE has potential utility as a post poisoning therapy. The investigators suggest that the data provide the first tangible evidence of the predicted mechanisms of post poisoning intervention with rBChE.
"The majority of our research to date for Protexia® has focused on studying its efficacy as a pre-exposure prophylactic. The promising preliminary data are particularly encouraging as they demonstrate that the non-pegylated rBChE may also be efficacious as a therapeutic for nerve agents. We plan to undertake further confirmatory work with Protexia® to build upon these exciting preliminary observations," said Mr. Wright.
Valortim® Findings Reported
In a poster entitled, "Efficacy of Intravenous Valortim®, an Anti-toxin Monoclonal Antibody, in the Treatment of Inhalation Anthrax in the African Green Monkey Model," investigators at USAMRIID sought to refine the AGM as a therapeutic model by assessing the efficacy of an anti-toxin monoclonal antibody. In the study, 21 adult AGMs were exposed by aerosol to Ames anthrax spores and blood samples were collected every 4-8 hours beginning 24-hours post exposure to assess anthrax bacteremia and protective antigen in blood. Samples were analyzed for protective antigen via a rapid electrochemiluminescent immunoassay (ECL) and bacteremia was evaluated by 24-hour culture. In the study, 6 AGMs were treated with one intravenous dose of 10 mg/kg Valortim® when positive by ECL; a second cohort of 6 AGMs was treated with 2 intravenous doses of 10 mg/kg Valortim® (the first given when positive by ECL and the second dose administered 24 hours later), and a third cohort of 6 AGMs was treated with one intravenous dose of 20 mg/kg Valortim® when positive by ECL.
Results showed that 56% (10 of 18) of the Valortim®-treated animals survived while all saline-treated controls (3) succumbed to inhalational anthrax on or before the fifth day post-exposure. Extended time-to-death (days 6-9) was observed in 5 of the 8 Valortim®-treated animals that succumbed to inhalational anthrax.
An oral presentation entitled, "Valortim®, an Anti-toxin Monoclonal Antibody, for the Treatment and Post-exposure Prophylaxis of Inhalation Anthrax," provided a summary of the Valortim® development program.
In the Phase I clinical study, 46 human volunteers were administered either a single dose of intravenous (IV) Valortim® (dose range 0.3 mg/kg-20 mg/kg) or intramuscular Valortim® (100mg). Valortim® was found to be safe and well-tolerated with no drug-related Grade 2-4 or serious adverse events reported. PK analysis demonstrated a half-life of approximately 26 days for IV administration.
Valortim® has been tested in both the New Zealand White (NZW) rabbit and non human primate models to evaluate its efficacy in the post-exposure prophylaxis and therapeutic settings.
In the post-exposure setting, Valortim® was dosed starting one hour after spore exposure. Valortim® protected >85% of both NZW rabbits and non human primates at doses as low as 1 mg/kg beginning one hour after exposure to spores.
In the therapeutic setting, Valortim® was dosed starting at fixed time points after spore exposure (24 or 48 hours in the NZW rabbit) or after first demonstrating antigenemia by a positive ECL assay (AGM). Valortim® protected 88% and 42% of NZW rabbits that initiated treatment at 24 and 48 hours after spore exposure, respectively. When AGMs were treated with Valortim® at the time of first positive ECL after spore exposure, 56% of the animals survived.
"We are very excited about the animal model data from the AGM study, which showed over 50% of Valortim®-treated animals survived inhalational anthrax as compared to no controls. This is especially compelling given that the toxin-releasing bacteria were present in the bloodstream at the time treatment was initiated. The AGM model, which we have been developing with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) is believed to closely mimic the disease course of inhalational anthrax infection in humans. In this therapeutic model, treatment with Valortim® is begun only after anthrax toxin is first detected in the circulation. This model may provide an important improvement over existing therapeutic models for anthrax by precisely defining a standardized timing for therapeutic intervention," commented Mr. Wright.
surf1944
16年前
Elesclomol Two-Year Survival and Integrated Safety Data Presented at the 33rd Congress of the European Society for Medical Oncology
Monday September 15, 10:30 am ET
LEXINGTON, Mass.--(BUSINESS WIRE)--Synta Pharmaceuticals Corp. (NASDAQ: SNTA - News) today announced that two-year follow up survival data from its Phase 2b clinical trial in metastatic melanoma were presented at the 33rd Congress of the European Society for Medical Oncology (ESMO) in Stockholm. In addition, an integrated safety analysis from Phase 1 and Phase 2 solid tumor trials of elesclomol plus paclitaxel versus paclitaxel alone was presented. Elesclomol is an investigational drug candidate that triggers programmed cell death (apoptosis) in cancer cells by elevating oxidative stress, and is currently in a global, pivotal Phase 3 trial for metastatic melanoma, with other trials, in other indications, planned. Elesclomol is not yet approved for any indication in any market.
The Phase 2b clinical trial for metastatic melanoma compared the effects of treatment with elesclomol plus paclitaxel (N=53) to treatment with paclitaxel alone (N=28). Follow up showed that:
Two-year overall survival in the elesclomol plus paclitaxel group was 27%.
Two-year overall survival in patients initially treated with paclitaxel alone was 21%. Of those patients, 68% received elesclomol plus paclitaxel after disease progression, as allowed by the trial protocol. The two-year overall survival for the crossover group that received elesclomol was 26%. The two-year overall survival for the no-crossover group, patients who never received elesclomol, was 11%.
Median overall survival and one-year overall survival rates, consistent with higher survival rates in patients who received elesclomol, were unchanged from previously reported data. These results are summarized in the table below:
Elesclomol + Paclitaxel
(N=53)
All patients initially randomized to paclitaxel alone (N=28) Pac-alone patients who crossed over to elesclomol
(N=19)
Pac-alone patients who never received elesclomol
(N=9)
2 Year OS Rate 27% 21% 26% 11%
1 Year OS Rate 49% 43% 53% 22%
Median (months) 11.9 7.8 14.3 5.6
“The incidence of melanoma is increasing however there are few effective treatment options available for patients and their physicians,” commented Eric Jacobson, M.D., Senior Vice President and Chief Medical Officer, Synta. “The two-year overall survival rate for patients treated with elesclomol plus paclitaxel is encouraging, consistent with the previously reported one-year and median overall survival rates. Together with the previously reported positive results for the primary endpoint of the study, progression free survival, these overall survival results underscore the potential of elesclomol as an exciting new treatment option for metastatic melanoma patients. The ongoing, international Phase 3 SYMMETRYSM clinical trial of elesclomol in metastatic melanoma will provide further data on the potential role of this novel oxidative stress inducer in treating this deadly disease.”
Also at the ESMO conference, a poster was presented describing the results from an integrated safety analysis of patients enrolled in Phase 1 and Phase 2 solid tumor studies (melanoma, sarcoma and other solid tumors). The analysis showed that elesclomol plus paclitaxel demonstrated a safety profile similar to that of paclitaxel alone. The observed safety profile across the multiple studies was comparable to the safety profile observed in the Phase 2b melanoma trial.
Metastatic melanoma occurs when melanoma – a cancer that begins in melanocytes, the cells that make skin pigment, or melanin – spreads to other parts of the body.1,2 Worldwide, approximately 132,000 new diagnoses of melanoma are made each year,3 of these approximately 48,000 occur in Europe. Stage IV melanoma defines distant metastasis and continues to comprise an ominous prognosis, with a median survival of 6-9 months.4
In the past 35 years, the FDA has only approved two types of therapies for metastatic melanoma; however neither of these therapies have been shown to improve patient survival.
Elesclomol and Paclitaxel in Stage IV Metastatic Melanoma: 2-year Overall Survival (OS)5
The two-year follow-up of the randomized, double-blind, active-controlled, Phase 2b trial in patients with stage IV metastatic melanoma compared overall survival for the combination of elesclomol and paclitaxel versus paclitaxel alone in patients who received one or no prior chemotherapy treatment. A total of 81 patients were enrolled in the trial and were evaluated in this analysis. Patients received either 213 mg/m2 of elesclomol co-infused with 80 mg/m2 paclitaxel (n=53) or 80 mg/m2 of paclitaxel alone (n=28) in four-week cycles (once weekly for three weeks and one week’s rest) until disease progression.5 Disease progression was defined using industry standard RECIST criteria. Patients initially randomized to treatment with paclitaxel alone were eligible for crossover to treatment with elesclomol plus paclitaxel following disease progression.
“Advanced metastatic melanoma is a notoriously hard-to-treat disease - no standard of care exists, single-agent or combination chemotherapies do not impact overall survival, and there are also considerable toxicity and adverse event issues with other approved treatments. These data showcase the promising application of a novel therapeutic approach that may make melanoma, a largely chemo-resistant disease, more sensitive to chemotherapy,” said Dr. Steven O’Day, M.D., Primary Investigator and Chief of Research and Director of the Melanoma Program at The Angeles Clinic and Research Institute, California.
Integrated Safety Analysis
Also presented at ESMO were the results from an integrated safety analysis of 239 patients treated with elesclomol plus paclitaxel in 6 completed clinical trials conducted across 54 centers in the United States involving patients with melanoma, sarcoma, and other solid tumors. A control group of 30 patients treated with paclitaxel alone from the randomized, double-blind stages of two of the trials was considered. Results showed that elesclomol plus paclitaxel was associated with no more than 10% of patients having individual adverse events of Grade 3 or higher. The most frequently observed toxicities were consistent with use of paclitaxel alone with a possible slight increase (6% vs. 0%) in neutropenia. Other Grade 3 or higher adverse events included anemia (3%), deep vein thrombosis (3%), fatigue (3%), hyperglycemia (3%), hypophosphatemia (3%), extremity pain (3%), and dyspnea (3%). These results are consistent with previously reported safety data from the Phase 2b clinical trial of elesclomol in metastatic melanoma where the incidents of Grade 3 or higher individual adverse events on the treatment arm were also under 10%.
surf1944
16年前
Ahead of the Bell: Medarex downgraded
Thursday September 11, 7:44 am ET
Analyst doesn't expect melanoma drug ipilimumab's primary data until late '09, launch in '10
NEW YORK (AP) -- A JPMorgan analyst downgraded shares of Medarex Inc. Thursday, saying the stock will trade in place until the second half of 2009, when Medarex reports critical late-stage trial data for its melanoma drug candidate ipilimumab.
Matthew Roden said mid-stage data for the drug was not very strong, and he thinks investors will wait for late-stage data that proves ipilimumab is effective as a primary treatment for advanced melanoma. Until that time, he expects the stock to trade only at the value of Medarex's cash and royalties.
Roden cut his rating to "Neutral" from "Overweight." Previously, he said, he expected strategic alternatives or more developments from the Princeton, N.J., company's pipeline. He now expects ipilimumab to reach the market in late 2010.
Medarex is developing the drug in a partnership with Bristol-Myers Squibb Co. It is designed to treat advanced metastatic melanoma, a deadly type of skin cancer.
Medarex shares finished at $6.95 Wednesday, and have traded between $6.41 and $15.69 over the past year.
surf1944
16年前
Medarex Receives Milestone Payment from Pfizer for Investigational New Drug Application Filing
Monday September 8, 8:00 am ET
PRINCETON, N.J., Sept. 8 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX - News) today announced that it received a milestone payment for an undisclosed amount from its licensing partner, Pfizer Inc. (NYSE: PFE - News). This payment is a result of the submission of an Investigational New Drug (IND) application by Pfizer for the clinical development of an antibody generated by Medarex's UltiMAb® technology. Medarex may receive future milestone payments and royalties should this product candidate progress through clinical development and to the market.
"We are pleased with the progress that Pfizer has made in advancing this antibody, generated using our UltiMAb® technology, towards the clinic," said Howard H. Pien, President and CEO of Medarex. "The continued development progress by Pfizer and our other partners reinforces the potential of products generated using our UltiMAb® antibody technology to treat life-threatening diseases."
surf1944
16年前
Medarex Announces Initiation of Phase 2 Clinical Development Program for the Treatment of Lupus
Tuesday August 12, 10:00 am ET
Medarex to Receive Milestone Payment from MedImmune
PRINCETON, N.J., Aug. 12 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX - News) announced today that its partner MedImmune, Inc. has initiated a Phase 2A multi-dose clinical trial of MEDI-545 for the potential treatment of systemic lupus erythematosus (SLE or lupus). MEDI-545 is a fully human antibody generated by Medarex's UltiMAb Human Antibody Development System®. Under the terms of the agreement, Medarex will receive a milestone payment of an undisclosed amount.
The Phase 2A clinical trial is designed to evaluate the safety and tolerability of multiple subcutaneous dose schedules of MEDI-545 or placebo in adult patients with moderate to severe active lupus. The study will also assess the effects of MEDI-545 on disease activity in lupus patients. This randomized, double-blind, placebo-controlled trial is expected to enroll 80 patients and will be conducted at 20 sites in the United States.
MedImmune is also conducting a Phase 1 clinical trial for MEDI-545 in idiopathic inflammatory myositis, an immunological disease that involves chronic muscle inflammation, pain and weakness.
"Data from an earlier reported placebo-controlled Phase 1 study suggested therapeutic activity with single doses in patients with lupus and demonstrated an acceptable safety profile," said Geoffrey M. Nichol, M.B.Ch.B., Senior Vice President of Product Development at Medarex. "We are very excited about the role of the interferon alpha inflammatory pathway and look forward to exploring its potential in treating patients with lupus and other autoimmune diseases."
About MEDI-545
MEDI-545 (previously known as MDX-1103) is a fully human monoclonal antibody targeting interferon-alpha. Published data indicate that levels of interferon-alpha are elevated in many patients with active SLE and other autoimmune disorders, and may be associated with disease activity. Preclinical data from animal models suggest that MEDI-545 may suppress the abnormal immune activity associated with lupus by binding to multiple interferon-alpha subtypes seen in the serum of lupus patients.
In November 2004, MedImmune entered into a collaboration with Medarex to focus on two specific antibodies, one of which was MDX-1103 (now known as MEDI-545). Under the terms of the agreement, MedImmune is responsible for all ongoing clinical development activities. Prior to the beginning of pivotal studies, Medarex may elect to co-develop the products in return for the opportunity to co-promote and to receive a share of the commercial profits in the United States. In all other cases, Medarex will be entitled to receive milestone payments and royalties.
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