Expects to Begin Phase 2 Proof-of-Concept Trials in First Quarter of 2013

Novelos Therapeutics, Inc. (OTCBB: NVLT), a pharmaceutical company developing novel drugs for treatment and diagnosis of cancer, today announced that it has enrolled the first patient in a U.S. multi-center Phase 1b dose-escalation trial of its cancer-targeted molecular radiotherapeutic compound (131)I-CLR1404 (HOT) in cancer patients with advanced solid tumors. Details of the trial design are available on www.clinicaltrials.gov ID: NCT01495663, or at www.novelos.com in the ‘Clinical Trials’ section. Glenn Liu, M.D., University of Wisconsin Carbone Cancer Center, is the trial’s principal investigator.

“Patients with advanced solid tumors need new, safer and more effective therapies,” said Dr. Liu. “Based on animal data and initial data from a Phase 1a dosimetry trial, HOT appears to deliver radiation directly and selectively to tumors and cancer stem cells.”

“The data from this trial will be combined with calculation of effective doses for HOT based on quantitative positron emission tomography (PET) tumor imaging data using LIGHT, our small-molecule cancer-targeted PET imaging agent,” said Harry Palmin, President and CEO of Novelos. “Together, we believe this combination will enable us to commence HOT Phase 2 proof-of-concept trials in the first quarter of 2013 in advanced cancer patients with significant unmet medical need.”

About HOT

HOT (iodine-131 radiolabeled CLR1404) is a small-molecule, broad-spectrum, cancer-targeted molecular radiotherapeutic that we believe has first-in-class potential. HOT is comprised of a small, non-pharmacological quantity of CLR1404 (COLD) acting as a cancer-targeted delivery and retention vehicle and incorporating a cytotoxic dose of radiotherapy (in the form of iodine-131, a radioisotope that is already in common use to treat thyroid and other cancer types). It is this “intracellular radiation” mechanism of cancer cell killing, coupled with selective delivery to a wide range of malignant tumor types that imbues HOT with broad-spectrum anti-cancer activity. Selective uptake and retention has also been demonstrated in cancer stem cells compared with normal stem cells, offering the prospect of longer lasting cancer remission. In 2009 we filed an IND with the FDA to study HOT in humans. In early 2010 we successfully completed a Phase 1a dosimetry trial demonstrating initial safety, tumor imaging and pharmacokinetic consistency and establishing a starting dose for a Phase 1b dose-escalation trial. The ongoing Phase 1b dose-escalation trial is aimed at determining the Maximum Tolerated Dose of HOT. We expect to initiate HOT Phase 2 efficacy trials as a monotherapy for solid tumors with significant unmet medical need as soon as a minimal efficacious dose is established. We may determine such an effective dose upon seeing a tumor response in the Phase 1b trial or calculating it from ongoing PET imaging trials in cancer patients with LIGHT. Preclinical in vitro (in cell culture) and in vivo (in animals) experiments have demonstrated selective killing of cancer cells along with a benign safety profile. HOT’s anti-tumor/survival-prolonging activities have been demonstrated in more than a dozen xenograft models (human tumor cells implanted into animals) including breast, prostate, lung, glioma (brain), pancreatic, ovarian, uterine, renal and colorectal cancers and melanoma. In all but two models, a single administration of HOT was sufficient for efficacy. In view of HOT’s selective uptake and retention in a wide range of solid tumors and in cancer stem cells, its single-agent efficacy in xenograft models and its non-specific mechanism of cancer-killing (radiation), we expect first to develop HOT as a monotherapy, initially for solid tumors.

About Novelos Therapeutics, Inc.

We are a pharmaceutical company developing novel drugs for the treatment and diagnosis of cancer. Our three cancer-targeted compounds are selectively taken up and retained in cancer cells (including cancer stem cells) versus normal cells. Thus, our therapeutic compounds appear to directly kill cancer cells while minimizing harm to normal cells. This offers the potential for a paradigm shift in cancer therapy by providing efficacy versus all three major drivers of mortality in cancer: primary tumors, metastases and stem cell-based relapse. LIGHT is a small-molecule cancer-targeted PET imaging agent. We believe LIGHT has first-in-class potential and Phase 1-2 clinical trials are ongoing. HOT is a small-molecule, broad-spectrum, cancer-targeted molecular radiotherapeutic that delivers radiation directly and selectively to cancer cells and cancer stem cells. We believe HOT also has first-in-class potential. HOT Phase 1b dose-escalation trial is ongoing and we expect HOT to enter Phase 2 trials in the first quarter of 2013 as monotherapy for solid tumors with significant unmet medical need. COLD, a cancer-targeted non-radioactive chemotherapy, works primarily through Akt inhibition. We plan to file an IND for COLD in the first quarter of 2013. Together, we believe our compounds are able to “find, treat and follow”™ cancer anywhere in the body in a novel, effective and highly selective way. For additional information please visit www.novelos.com

Chromatin Inc., a developer of energy crop feedstock solutions, announced Jan. 4 the award of a $5.7 million contract under the PETRO (Plants Engineered to Replace Oil) program of the U.S. DOE’s Advanced Research Projects Agency-Energy (ARPA-E).

The award will fund a three-year program to develop new varieties of sweet sorghum for use as an energy-rich, low-cost feedstock for transportation fuels.

“Building on our success deploying our proprietary technology that can add multiple sets of genes to sorghum, we are able to produce sorghum varieties that meet the specific needs of renewable energy producers,” said Dave Jessen, Chromatin’s chief technology officer. “In collaboration with academic and industry experts, this award will accelerate Chromatin’s optimization of sorghum as a feedstock for drop-in biofuels and energy-rich replacements for coal and petroleum.”

Chromatin is working to develop nonfood varieties of sorghum that have higher energy content making it ideal for the production of low-cost and renewable transportation fuel, high-value chemicals and a high-Btu source of biopower. Sorghum can produce tremendous biomass yields with less water and fewer chemical inputs than major food crops and on land that is not devoted to food production.

Virent’s Plant-BAsed Paraxylene Paves the Way for a 100% Bio-PET Bottle

Virent and The Coca-Cola Company announced today they have entered into a new strategic partnership to accelerate the commercialization of renewable, recyclable materials for beverage packaging. The companies have signed multi-year, multi-million dollar Joint Development and Supply Agreements to scale-up Virent’s plant-based Paraxylene (PX), trademarked BioFormPX™, as a route to commercially viable, 100% renewable, 100% recyclable PlantBottle™ PET resin. Virent’s BioFormPX will be used in Coca-Cola’s existing supply chain to make 100% bio-based PTA that will be mixed with biobased MEG to produce PlantBottle™ PET Resin with 100% bio-based content.

“The Coca-Cola Company’s commitment to provide its customers with PlantBottle™ packaging made from 100% renewable and recyclable materials is a bold example of visionary brand leadership,” said Lee Edwards, CEO of Virent. “I am delighted that Virent’s partnership with Coca-Cola will play a significant role in achieving this vision.”

“While the technology to make bio-based materials in a lab has been available for years, we believe Virent is a company that possesses technologies that have high potential for creating them on a global commercial scale within the next few years,” said Rick Frazier, Vice President, Commercial Product Supply, The Coca-Cola Company. “This is a significant R&D investment in packaging innovation and is the next step toward our vision of creating all of our plastic packaging from responsibly sourced plant-based materials.”

Virent and The Coca-Cola Company will rapidly progress both development and engineering under this effort, with Virent targeting 2015 for the first commercial plant opening. The majority of the PX produced from Virent’s first plant will be allocated for purchase by The Coca-Cola Company’s supply chain partners for the Company’s product packaging. Virent will reserve the remainder of the BioFormPXTM for market development in complementary PET and polyester applications.

The world’s largest soft-drink maker introduced the PlantBottle™ packaging in 2009, which consists of a conventional plastic made with up to 30 percent plant-based material. Since that time, The Coca-Cola Company has aggressively sought viable plant-based options for the remaining 70 percent of the material. Virent’s BioFormPX™ product will allow Coca-Cola to offer its customers up to 100% renewable, 100% recyclable bottles which can be processed through existing manufacturing and recycling facilities.

About Virent

Virent is replacing crude oil by creating the chemicals and fuels the world demands using a wide range of naturally-occurring, renewable resources. Their patented technology features catalytic chemistry to convert plant-based sugars and agricultural residues into a full range of products identical to those made from petroleum, including gasoline, diesel, jet fuel, and chemicals for plastics and fibers. The products are “drop-in” replacements that enable full utilization of existing logistics infrastructure without blending limitations. The development of Virent’s BioForming® technology platform is supported through strategic investors including Cargill, Shell and Honda, as well as 120 employees based in Madison, Wisconsin.

In this extended version of the talk from our latest issue, we speak with Mary Tilton, VP of plant operations at Virent, which is using chemistry to turn plants into fuel.

Photo by Saverio Truglia

“We are replacing crude oil. We’re using catalytic chemistry to manipulate the carbon-oxygen bonds of sugars and other bio-derived materials to turn them into hydrocarbon fuels and chemicals. That same catalytic chemistry can take plant materials and turn them into the components of crude oil, which include the chemicals for plastics. We now have a material that is exactly like what you burn in a vehicle, which is an advantage because it can go right into the distribution pipeline. The only difference between our fuel and gasoline from crude oil is that our carbon is new, whereas the carbon in crude oil is millions of years old. The fuels we’ve generated have been used in Shell’s fleet test.”

Fast Company: How did the company get started?

Mary Tilton: The technology was first developed at the University of Wisconsin in Madison by our founder, Randy Cortright. Originally, we focused on hydrogen generation, and the company was founded to commercialize that technology. Sometime around 2005 we realized the catalytic processes we were using could be tailored to make hydrocarbon fuels. So our focus shifted and became looking into using sugars to make gasoline. That’s what we really concentrated on in 2008 when we embarked on the scale-up and decided to go to 10,000 gallons a year. We found we were very successful at taking standard sugar and converting it to gasoline. We demonstrated scalability in 2009, which was an important milestone.

Where does the feedstock come from?

So far, we’ve purchased our feedstock from a very large agricultural supplier. We’re partnering and working with various companies to further develop that source. We have partners engaged in both the upstream and downstream, which is one of our key strengths as a company. We’re sort of in the middle of things: We’re working very closely with Cargill on the upstream side of things for feedstock availability, and then on the downstream side we’re working very closely with Shell. We have a unique technology, and we need to position ourselves to be able to work on larger projects, such as the question of where you get feedstock, and our partners help us do that.

Are there any downsides to making fuel in a lab as opposed to getting it in the form of petroleum from the earth?

We all believe in the companies we work for, but as an independent observer, I cannot think of a technical pitfall of it. I seriously, truly cannot. It’s important, though, to consider using non-food materials, like corn stover, for instance, and wood products that are renewable. The challenge is always how you get the digestible materials out. Plants have been creating their barrier to destruction for many, many years, and it’s going to take some very good science to be able to liberate those sugars.

Does it take a lot of energy to actually turn these feedstocks into usable fuels?

We’ve engaged in all the life-cycle analyses for what it takes to bring biomass materials into a facility to convert them–what the energy consumption is. Our technology process is relatively low energy, and at the end, it’s energy neutral. It is definitely not consuming more energy than you would get out of the fuel. All of those energy balances are in our favor.

What will it take for people to start using biofuels?

It’ll require a lot of capital for this to take off. This hasn’t been a very friendly economy for large investments. The material itself for the end product needs to be competitive with the price of consumer fuel. We’re looking at a commodity market, and I know consumers aren’t hungry to pay more even if they believe it’s a good product. The material needs to be cost competitive. The advantage of drop-in fuel is you don’t have to make a lot of change in the infrastructure. Our product is just like what you’re using, except it has a lower carbon footprint. It can go into the distribution pipeline and be put in pumps right now without changing tanks.

A boy tries to outrun a man fumigating for mosquitoes in an effort to combat dengue fever, on the streets of Lahore, Pakistan, September 20, 2011.

The World Health Organization estimates that 2.5 billion people – more two-fifths of the world’s population – are at risk of infection with Dengue fever, a mosquito-borne illness that in its worst form can cause death. Until now, efforts to develop a vaccine against the disease have been unsuccessful. Researchers say a couple of experimental vaccines are showing promise.

Since Dengue fever was first identified a half century ago, the incidence of the disease has grown dramatically. The World Health Organization says Dengue fever today is endemic in more than 100 countries, and more than 50 million people are infected every year.

Scott Halstead, senior advisor to the Dengue Vaccine Initiative, an international consortium of medical research groups, said that fluid treatments for the disease have reduced mortality from the most severe form of the illness. But Halstead added that the rainy season in many parts of the tropics and subtropics – when Dengue-carrying mosquitoes are breeding and biting – is still a time of special anxiety because there is no specific medication or cure for Dengue fever:

“While the mortality rate, in reality, is relatively low because of the availability of good hospital treatment, this is almost unlike any other major infectious disease,” said Halstead.

In its worst form, Dengue fever, also known as “breakbone fever,” can cause severe internal bleeding, circulatory failure, shock, coma and death.

There are four related, but distinct, types of the Dengue virus that are transmitted by the bite of the Aedes aegypti mosquito. The difficulty in developing a vaccine, according to Halstead, is that a person may develop immune system antibodies against one type of virus, but would have no immunity against the other types.

Halstead said that sets the stage for more serious infection later on.

“The antibodies that are left over from the first infection interact with the second type of the virus, and what we say is it “enhances” the infection; it makes it more severe the next time you’re infected with a different type of virus,” said Halstead.

Experts say it’s usually a second infection with a different Dengue virus that leads to the most severe and sometimes fatal form of the disease – Dengue hemorrhagic fever.

Two promising vaccine candidates now are in the works to protect against all types of Dengue virus. Both vaccines contain the four types of live but weakened viruses, designed to stimulate the body’s production of neutralizing antibodies against all Dengue types.

French drug maker Sanofi-Pasteur has reportedly invested nearly $1 billion to develop a vaccine that is proving highly effective in phase-three human clinical trials in Thailand, the last step before regulatory approval. A second vaccine, being developed by U.S. drug maker Inviragen, also has proved to be safe and effective in phase-one human trials.

Dan Stinchcomb, Inviragen’s chief executive officer, said that despite the millions of dollars it has spent so far to develop the Dengue vaccine, the company hopes to keep it affordable.

“Our intention is to try to produce the vaccine at low cost so that we can provide it with help of funding to the poorest in need of the vaccine,” said Stinchcomb.

Progress on both Dengue vaccine candidates was reported at the recent meeting of the American Society for Tropical Medicine and Hygiene in Philadelphia, Pennsylvania.

Dr. Gilad Gordon has been hired as chief medical officer at Inviragen, a Fort Collins-based biomedical company.

Gordon was most recently employed at ORRA Group, LLC, a medical consulting firm, and has held various senior management positions at small and large pharma companies including FeRx, Ri-bozyme, MediQual, Synergen and Eli Lilly.

Gilad Gordon

Gordon completed his training in internal medicine at the University of Colorado Health Sciences Center. He currently serves as Clinical Associate Professor of Medicine at the University of Colorado Denver, where he also has served as an attending physician at the Denver VA Medical Center.

CSU chemistry prof honored by CBA

The Colorado Bioscience Association recently recognized Melissa Reynolds, assistant chemistry professor, as Educator of the Year.

This is Reynolds’ second major award in the past year. In 2010, the Boettcher Foundation named Reynolds as one of only six inaugural Boettcher Investigators as part of the Webb-Waring Biomedical Research Pro-gram, which helps recruit, retain and advance scientific talent in Colorado. She was the only one from Colorado State named that year.

The Colorado Bioscience Association acknowledged Reynolds because “in addition to teaching graduate and undergraduate courses, she has organized professional development and entrepreneurship programs and mentored over 25 multidisciplinary students.

Reynolds has developed a biodegradable polymer with healing properties – essentially a soft plastic – that could be used inside or outside the human body.

Chromatin, Inc., a developer of energy-crop feedstocks, today said it has used its proprietary mini-chromosome technology to enable the improvement of sorghum with multiple new sets of genes. This is a major milestone in Chromatin’s program to customize sorghum to meet the specialized needs of power, fuel and chemical producers.

Using its mini-chromosome technology, Chromatin was able to simultaneously introduce multiple genes into a plant cell on an independent chromosome without impacting the host genome. In contrast, more traditional crop transformation technologies usually introduce only a single gene, or limited numbers of genes, and involve disrupting the plant’s genome when introduced.

“We are focused on enhancing sorghum feedstocks to increase yields and enhance the quality of fuel, power, and chemical production,” said David Jessen, Chromatin’s Chief Technology Officer. “In addition to a robust crop breeding program, the ability to add a large number of genes with our proprietary mini-chromosome platform makes it possible to enhance sorghum in a controllable and efficient way.”

Chromatin demonstrated its sorghum mini-chromosome technology by inserting a gene “stack” into a sweet sorghum line. Sweet sorghum, much like sugarcane, produces ample quantities of sugar-rich juice that can be used by processors to generate fuels and renewable chemicals. Sorghum can be grown today from the tropics to temperate regions, on marginal lands not ideal for food production and under harsh growing conditions. In addition to enhancing sweet sorghum, mini-chromosome technology can be used to modify other sorghum types, including grain and forage sorghums.

“As we examined several different sorghum lines containing mini-chromosomes, we were pleased to see that the gene stacks behaved as expected,” commented Otto Folkerts, Director of Transgenic Programs at Chromatin. “We are confident that we can create new sorghum hybrids that carry the genes needed for improvement, while keeping the native host genome intact.”

Chromatin also has licensed its proprietary mini-chromosome technology to leading international agriculture companies working on corn, soybeans, cotton and sugarcane.

About Chromatin:

Chromatin, Inc. is developing renewable energy-crop feedstocks for power, fuel and chemical producers. It also is developing expertise in the supply chains to serve energy fuel and chemical producers and is serving growers by developing high-value next-generation sorghum seeds using its proprietary crop- breeding technology and biotechnology programs. The company licenses its innovative gene-stacking technologies to support the crop-breeding programs of leading agriculture companies, and it applies these technology platforms to its subsidiary, Sorghum Partners LLC, which produces and markets hybrid sorghum seeds to growers in the US and more than 20 other countries. Chromatin is privately owned and based in Chicago. For additional information, please visit www.chromatininc.com