ProActive News Room Blog

Mike Havrilla (@mikehavrilla) on Twitter

My Twitter account (@mikehavrilla) includes frequent updates throughout the day in real-time for notifications and web links to new investing articles, research reports, FDA / clinical trial updates, and bio-medical industry news.

Click on the link below to subscribe via email or feed reader (e.g. My Yahoo!, iGoogle, etc.) to my Twitter updates in real-time throughout the day, delivered by Google's FeedBurner service.

 

Subscribe by email or reader

Industrial Nanotech($INTK) Announces Large Order from Saudi Arabia Distributor

http://finance.yahoo.com/news/Industrial-Nanotech-Inc-bw-444800996.html?x=0&.v=1

$GOOG - break of 525

As per yesterday's note - GOOG has broken 525 - next target 500

I own GOOG Puts

Buying $EDZ Emerging Markets Bearish Play

I am buying shares of EDZ - a bearish play on emerging markets with 3X leverage

Updated Executive Summary for Access Pharma (OTC: ACCP.OB)

Access Pharma (OTC: ACCP.OB) is an emerging bio-pharmaceutical company which is focusing on the development of a late-stage, diversified oncology pipeline in addition to a treatment called MuGard that is cleared for marketing in the U.S., Europe, and other key global markets for a common side effect of some cancer treatments known as mucositis (painful sores in the mouth and GI mucosal lining). In addition, the Company is developing earlier stage compounds in its pipeline and has an oral cobalamin nanopolymer drug delivery technology which has demonstrated positive results for the delivery of insulin by mouth in preclinical animal models.

Access expects to maintain a low cash burn rate of approximately $5 million during 2010, as compared to an operating budget of approximately $35 million - reflecting the significant benefit provided by partner funding such as the clinical development of ProLindac in the Asia-Pacific region. In addition, the current cash and expected milestone payments this year provides adequate funding for all development and commercialization plans through at least mid-2011, which does not take into account MuGard royalties from SpePharm in Europe and pending sales of the product in North America.

Last December, ACCP.OB provided an update on its European commercial launch of MuGard, an FDA approved treatment for oral mucositis, a debilitating side effect of radiation treatment and chemotherapy. MuGard is commercially launched by Access' partner, SpePharm, in six European countries, including the UK, Germany, Italy, Norway, Greece and Sweden. Access is conducting pre-marketing activities, including ramping of commercial production, with the goal of a commercial launch during March / April 2010 in U.S.

Over 15,000 bottles of MuGard have been used by over 2,000 patients since launch. SpePharm is currently gathering feedback from clinicians in the UK, Germany and Italy that are participating in a patient assessment project and expects that out of a total of approximately 1,500 patients who will be given MuGard in this project, a consistent number of patient forms will be collected by year end, and the information will be quality checked for potential presentation at a scientific or medical conference or meeting during 1H10, such as the Multinational Association of Supportive Care in Cancer (MASCC) that will be held June 24-26 in Vancouver.

Thiarabine is ACCP's next-generation nucleoside analogue (e.g. fludarabine, cladrabine) designed for the treatment of blood-based cancers such as lymphoma and leukemia. Access is currently working with leukemia and lymphoma specialists to initiate additional Phase 2 clinical trials in acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), and B-Cell lymphomas. These pilot studies are expected to begin during 2Q10 and will seek to determine the optimal dosage regimen and most susceptible malignancies for future trials to serve as the basis for partnership discussions for further development and commercialization.

In early January, Access announced successful results in a small, pilot study that validates the new, scalable manufacturing process for ProLindac that is a key component for partnership discussions and large-scale production of the drug for late-stage / pivotal studies and potential commercialization. ProLindac is a next-generation DACH platinum anti-cancer compound which includes a proprietary nano-polymer drug delivery vehicle that allows for over 10X the dose of platinum to be delivered in a targeted manner to cancer cells with a much better safety profile compared to standard platinum-based drugs which cause significant and cumulative neurotoxicity.

Access will also conduct a combination study evaluating ProLindac plus Taxol (paclitaxel) for second-line treatment of platinum pre-treated patients with advanced ovarian cancer. This is a multi-center study being conducted in Europe in up to 25 evaluable patients with primary efficacy endpoint goal of achieving at least a 63% response rate and expects to begin patient dosing by March-April 2010. The initial cohort of about 10 patients will begin the study as an open-label, dose-escalation study that is expected to provide initial results during 3Q09 and a possible partnership or larger pivotal Phase 3 trial could begin during 2H10.

Access has developed a nano-polymer drug delivery system for the oral administration of large molecules that are currently administered as injections (e.g. insulin, human growth hormone/hGH, erythropoietin/EPO, fertility drugs, parathyroid hormone/PTH, RNA-based therapeutics, monoclonal antibodies). This drug delivery technology involves coating a nano-particle with a vitamin B-12 analog (cobalamin) that binds to intrinsic factor in the gut and triggers binding to cellular receptors which absorb the entire package, resulting in exponential increases in absorption through the gut of large molecule drugs / hormones typically administered by injection.

 In June 2009, Access announced that two bio-pharmaceutical companies (one North American, one European) would conduct preclinical, proof-of-concept studies in animals (rat and dog models of diabetes) before proceeding to more formal negotiations for the Company's oral, long-acting (basal) insulin product candidate, seeking to validate the greater than 80% oral insulin bioavailability results achieved by Access in preclinical studies for its oral insulin formulation. Final results from the non-exclusive collaborators are possible during 1Q10 while Access may initiate proof-of-concept (Phase 1 equivalent) studies for oral insulin in humans in Eastern Europe or India during 2H10 (with expected duration of 3-5 months and cost of $250-300,000), and also plans to file an additional patent application reflecting improvements to the technology.

With the recently announced financing that included the sale of common stock / warrants at $3 per share, Access will have approximately $7 million in cash / equivalents and 25 million shares of common stock outstanding on a fully diluted basis (up to 30 million shares taking into account outstanding warrants, etc.) plus a $5.5 million note outstanding which is due at the end of 2011. The outstanding note is expected to be paid in part or full by possible upfront payments as part of co-promotion licensing deal(s) for MuGard in North America which could be combined with a reset of the current $27.50 conversion price.

Additional analyst coverage is also possible throughout 2010, including firms such as Rodman & Renshaw (NASDAQ: RODM), which served as the sole lead placement agent in the recently closed financing. Also, listing of Access shares is anticipated on the AMEX, which should provide greater liquidity and improved bid / ask spreads for trading of the stock. Finally, MuGard sales projections at 12-months post-launch include annualized revenue run rates of $30 million for Europe at 20-25% royalties (i.e. $2.5 million per month) and $50 million for North America (i.e. approximately $4 million per month.

Disclosure: Long ACCP.OB

Google ($GOOG) 500?

Looks like Google heading to test of 500 - confirmed on break of 525

Will Dow hold 10,000?

Barring any major upside employmet surprises tomorrow, it seems inevitable that we break 10,000 and test support between 9600 and 9800 shortly thereafter. 

200 Day Moving average is around 9600    seems like only logical next support

Waste2Energy: Making Electricity from a Town’s Garbage

 

Waste2Energy: Making Electricity from a Town's Garbage

 

The average American generates nearly a ton of trash each year. Each suburban home annually produces 15 pounds of hazardous household waste including medications, paints, solvents and automotive products.

 

Where does all this waste go?  Most goes into the ground at landfills. According to the Environmental Protection Agency, only 32 percent of waste in the United States is recovered or recycled. Another 14 percent is burned at combustion facilities. These statistics don't count the enormous amount of waste that is illegally burned in barrels or buried in landfills constructed without permits.

 

This problem is compounded by over-population. Most experts believe that the ideal population for the United States ranges between 100 and 150 million people. This is compared to our current population of 308 million. The numbers will get much worse. The U.S. population, predicts the World Facebook, is expected to rise to 451 million in 2050 and then 595 million in 2100.

 

Waste management is already a huge problem for the United States. President Obama's economic stimulus package passed in early 2009 attempts to begin dealing with the elimination of waste and the creation of energy. It includes $3 billion for development of renewable energy projects, $600 million to cleanup hazardous waste and $6.3 billion for state and local governments to make investments in energy efficiency. The program will provide direct payments in support of an estimated 5,000 biomass, solar, wind and other types of renewable energy production facilities.

 

Waste management and energy production are also key to green building initiatives. An estimated 61 percent of America's contractors rate waste management the second most important aspect of green construction, just behind energy efficiency. This was found in a new SmartMarket Report released at the Greenbuild International Conference and Expo in November, 2009.

 

Well-positioned to tackle this environmental problem in the United States is Waste2Energy, a new company based in Greenville, S.C. that designs, builds, installs and sells waste-to-energy plants. These facilities convert biomass or other solid waste streams traditionally destined for a landfill into clean renewable energy.

 

In November 2007, the company acquired EnerWaste International Corp. and in May 2008 it bought Enerwaste Europe in Iceland. With these acquisitions, Waste2Energy purchased two state-of-the-art technologies based on gasification and the clean oxidation of waste.

 

Some background is perhaps necessary. Gasification is a technology that has been in use since the 1800s when it was first developed to produce town gas for lighting and cooking. During World War 11, wood gas generators were used to power motor vehicles in Europe during fuel shortages. It was called gasogene.

 

Gasification converts carbonaceous materials such as biomass, biofuel, coal, plastic, woodchips and other waste materials into carbon monoxide and hydrogen by reacting it at high temperatures with a controlled amount of oxygen or steam. The resulting gas mixture is called synthesis gas, or "syngas." A fuel itself, syngas can be used for heat production and for generation of mechanical and electrical power.

 

Traditionally, gasification technology has been used to process a specific type of waste material to generate a consistent output of syngas. This means the waste must be pre-processed first for use in the gasification process. Usually made into pellets or other usable form of material, the preprocessing of the waste requires using a large amount of processing and storage space, a complex transportation infrastructure and expensive operational logistics.

 

Waste2Energy employs a two-stage process that broadens the kinds of waste materials that can be fed into the system to generate clean energy. The company's technology is ideal as a smaller, community-based waste management-energy production solution that is efficient to operate and cost-effective. It is designed as a thermal treatment of waste that's an alternative to incineration.

 

In the Waste2Energy process, gasification is accomplished in stage one. The gasification is done at a high enough temperature to sterilize the waste, but at a low enough temperature not to change the molecular structure of the material. This stage produces syngas. A residual from this process is ash. Within this ash are traces of various inorganic materials-such as steel, plastics and other materials depending on the type of waste-that can be recycled if the operator desires.

 

In the second stage, the syngas goes into a second chamber where it is subjected to a very high temperature and has more than a two-second retention time. This cleans the syngas of toxic material and creates a clean hot flue gas. The composition of the flue gas depends on what is being burned, but it will usually consist of mostly nitrogen (typically more than two-thirds) derived from the combustion air, carbon dioxide(CO2), water vapor and excess oxygen.

 

The hot flue gas-the key product of the Waste2Energy process-can be converted to superheated steam to drive a turbine to create electricity. Or possibly it could be used for fuel cells, thermal desalination or other alternate forms of energy. The operator decides on the end product.

 

At the moment, Waste2Energy has a patent pending relating to its batch process for waste that allows the system to create a consistent flow of flue gas. What distinguishes the company's solution is that the preprocessing of the waste is not necessary. This allows the Waste2Energy technology to be decentralized, localized and community-oriented, with reduced transportation costs and far less road congestion due to waste dumping trucks.

 

To demonstrate its technology, Waste2Energy is a participant in building a new waste-to-energy plant which opened this summer near Dumfries in Scotland. It is the most advanced facility of its kind in Europe. When fully commissioned by early 2010, the new plant will initially process about 120 metric tons of mixed waste each day and generate about eight megawatts of power. It is capable, say its operators, of dealing with the waste from a community of 250,000 people.

 

The facility in Scotland will be the first showcase demonstration facility for Waste2Energy. It incorporates four intake chambers and will use a blend of different kinds of wastes for conversion to clean electricity. In industry jargon, waste product for feeding the system is called "feedstock."

 

Because the Scotland plant requires no preprocessing of the feedstock, it was built on less than two acres of land. Competing projects that must preprocess the same amount of waste require eight to ten acres of land for storage and facilities. The cost savings are huge.

 

Waste2Energy insists the success of its small plants lie with the skills of the operator who controls the feedstock. Their expertise is normally the measure of success or failure in making a facility profitable. Waste2Energy requires that prospective clients complete a comprehensive application that seeks to determine whether or not the client can use a waste-to-energy facility.  It's called a "waste characterization profile."  The results of the rigorous application have surprised many potential users, some who found they didn't generate sufficient waste to use the process.

 

Interestingly, the types of waste vary dramatically from place to place around the globe. Because of this fact, Waste2Energy-designed plants work better in some places than others. In some countries, the waste includes large amounts of discarded food- which includes much moisture-while others contain the remains of automobiles or demolition debris. The type of mixed waste determines the amount of electricity that can be produced from a facility.

 

Caribbean islands, and resort islands in general, find great value in the Waste2Energy technology. Islands tend to have a high electricity cost-usually from imported diesel fuel-and require transporting waste offshore to landfills or other processing systems in a garbage-adverse tourist environments. Hotels, hospitals, military bases and mining camps also generate their own wastes.. The company recently received a letter-of-intent from the island of Sint Maarten to design and construct a 300 metric ton per day waste-to-energy facility

 

Waste2Energy's technology has also been selected to be used in the construction of six new gasification resource parks to be located in the United Kingdom. The plants will treat in excess of 600,000 metric tons of commercial and industrial waste. The project is one of the largest ever committed to developing gasification capacity in the UK and, as planned, will produce enough electrical power for over 85,000 homes.

 

Waste2Energy doesn't see itself as a suitable solution for every project in a nation as large and diverse as the United States. For areas with vast space for landfills and cheap electricity, they admit they don't fit. If a city wants a central 25 megawatt power station driven by waste, a larger system would be a better fit. However, if a small town or group of small towns want to treat 60 to 360 tons per day and generate 2 - 15 megawatts of electrical power, Waste2Energy offers a very cost effective solution.

 

As towns and cities consider the possibilities of alternate technologies, the management of Waste2Energy see communities joining together for public-private partnerships with experienced operators. In some cases, it would involve the creation of a waste-to-energy industrial park where citizens would bring waste to be processed.  Such ventures may more resemble a real estate transaction than an industrial solution.

 

Whatever the final form, the waste management problem is not going away. As the U.S. population increases, landfills become harder to justify and costs rise. Solutions are going to be needed. 

 

"There are a lot of gasification companies out there and many of them scale up very well," said Christopher d'Arnaud-Taylor, chairman of Waste2Energy.  "Our philosophy is the exact reverse of that-our technology scales down. That's important. If you can scale down, then you can get a community-based solution, which is where we want to be as a company."

 

Waste2Energy Inc. is a client of ProActive Capital Resources Group, LLC.  Please see our disclosures and disclaimers page. 

Keryx / Aeterna Drug Shows Promise in Late-Stage Colon Cancer Patients

The ProActive News Room website for Keryx Biopharma (NASDAQ: KERX) has been updated to include the Company's most recent corporate presentation and the GI-ASCO 2010 poster presentation from last weekend. In the randomized Phase 2 trial, perifosine + capecitabine (P-CAP) demonstrated a statistically significant improvement in TTP (time to progression) and OS (overall survival) compared to placebo + capecitabine (CAP) in patients with second or third-line mCRC (metastatic colorectal cancer). ORR (overall response rate) was also improved for P-CAP over CAP.

Perifosine is in-licensed by KERX from Aeterna Zentaris (NASDAQ: AEZS). During 2010, KERX expects to report updated data from its Phase 2 colon cancer study, conduct / update additional earlier stage Phase I/II studies, finalize late-stage trial protocol for colon cancer study, and begin a late-stage study for colon cancer patients in addition to the ongoing pivotal Phase 3 study for multiple myeloma under a Special Protocol Assessment (SPA) with the FDA. KERX is preparing to begin a pivotal Phase 3 trial of perifosine in patients with mCRC and an additional SPA with the FDA for this indication is expected within the next three months.

Below are some highlights from the GI-ASCO poster presentation:

1.) The improvements in TTP and OS with P-CAP compared to CAP are also seen in patients with 5-FU refractory disease. One patient with 5-FU refractory disease had a PR on P-CAP.

2.) P-CAP was well tolerated compared to CAP alone.

3.) A Phase I study to evaluate the combination of perifosine + capecitabine using a higher dose of capecitabine at 1000 mg/m2PO BID days 1 -14 is underway. PK of perifosine and capecitabine are being examined.

4.) Given the improved clinical efficacy of P-CAP compared to CAP in 5-FU refractory patients, a randomized Phase III study comparing P-CAP to CAP in patients with refractory mCRC is planned.

Below is a summary of additional expected catalysts and milestones for KERX:

On 12/16/09, KERX announced the initiation of a Phase 3 pivotal study of perifosine (KRX-0401), the Company's PI3K/Akt pathway inhibitor, in multiple myeloma patients. It is structured as a double-blind, placebo-controlled trial comparing the efficacy and safety of perifosine vs. placebo when combined with bortezomib (Velcade) and dexamethasone and will enroll 400 patients with relapsed or relapsed / refractory multiple myeloma. The primary endpoint is progression-free survival and secondary endpoints include overall response rate, overall survival and safety. Approximately 265 events (defined as disease progression or death) will trigger the un-blinding of the data. KERX expects a patient recruitment period of approximately 16-18 months and expects to report data from this study during 2H11.

On 1/5/10, KERX announced that it has reached agreement with the FDA regarding a SPA on the design of a Phase 3 clinical program for Zerenex (ferric citrate), its iron-based phosphate binder for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD). In accordance with the Company's SPA agreement with the FDA, the Phase 3 clinical program for Zerenex will consist of two clinical studies, including (1) a short-term efficacy study that is expected to commence by the end of 1Q10 with date expected during 2H10; and (2) a long-term safety and efficacy study that is expected to begin mid-2010 with data expected and a NDA filing expected during 1H12.

KERX also has a partnership in Japan with JT Torii that includes over $100 million in potential milestone payments. The ongoing Phase 2 study in Japan is near completion and KERX expects the Phase 3 trial to begin during 2H10, which will trigger a development milestone payment that is in the mid single digit million dollar range. An additional $15 million milestone is possible upon regulatory approval in Japan, with approximately $55 million in remaining milestone payments based on the achievement of sales targets upon commercialization.

Disclosure: Long KERX

Access Pharma's Drug Delivery Technology is a Stealth Asset

Access Pharma (OTC: ACCP.OB) provided an update today on the status of its cobalamin-based oral drug delivery product development programs. The BioMedReports.com research downloads section and the ProActive News Room website for Access both contain the most recent research reports and presentation for the Company, following its presentation last week at the OneMed Forum in San Francisco, which was held in conjunction with the JP Morgan Healthcare Conference.

Access has developed a nano-polymer drug delivery system for the oral administration of large molecules that are currently administered as injections (e.g. insulin, human growth hormone/hGH, erythropoietin/EPO, fertility drugs, parathyroid hormone/PTH, RNA-based therapeutics, monoclonal antibodies). The oral insulin and hGH formulations represent the most developed product candidates in terms of preclinical studies and formulation, in preparation for potential licensing deals and / or proof-of-concept clinical trials in humans.

This drug delivery technology involves coating a nano-particle with a vitamin B-12 analog (cobalamin) that binds to intrinsic factor in the gut and triggers binding to cellular receptors which absorb the entire package, resulting in exponential increases in absorption through the gut of large molecule drugs / hormones typically administered by injection.

In June 2009, Access announced that two bio-pharma companies (one North American, one European) would conduct preclinical, proof-of-concept studies in animals (rat and dog models of diabetes) before proceeding to more formal negotiations for the Company's oral, long-acting (basal) insulin product candidate, seeking to validate the greater than 80% bioavailability achieved by Access in preclinical studies for its oral insulin formulation.

Final results from the non-exclusive collaborators are possible during 1Q10 while Access may initiate proof-of-concept (Phase 1 equivalent) studies for oral insulin in humans in Eastern Europe or India during 2H10 (with expected duration of 3-5 months and cost of $250-300,000), and also plans to file an additional patent application reflecting improvements to the technology.

While most investors are focused on the oncology products (MuGard) and pipeline (ProLindac, Thiarabine, Angiolix) for Access Pharma; the oral cobalamin drug delivery technology platform represents an undervalued and under-the-radar asset that is poised to gain more attention (and value) as the year progresses from additional preclinical / validation results for oral insulin, pending proof-of-concept studies in humans, potential licensing agreements, and the possibility for developing new compounds / therapeutic classes (e.g. RNA-based therapeutics) using this technology.

Disclosure: Long ACCP.OB