According to official CDC data, childhood obesity has more than doubled in the past three decades among children (it has tripled among adolescents), and the portion of kids in the country aged six to eleven who are obese, now stands at nearly 20 percent. Type 2 diabetes (often called adult-onset diabetes), once virtually unheard of in people under the age of 30, is now rising to such staggering prevalence among children and adolescents that peer-reviewed medical journal Diabetes Care recently described it as an emerging epidemic. Increasingly sedentary lifestyles among today’s children, driven by factors like mounting screentime and further exacerbated by a diet typically consisting of processed or junk foods that are laden with high-fructose corn syrup or equally problematic chemical sweeteners, has produced an extremely dangerous situation for many. And the cycle of unhealthy choices all begins with eating and playing habits that are established when we are young.

This fundamental problem is one of the driving forces behind the creation of the Giggles N’ Hugs, Inc. (OTCQB: GIGL) brand of family-friendly, upscale casual dining restaurants, which feature enormous 2,000 square-foot-plus children’s indoor playspaces, where kids under 10 can run, jump, and play to their heart’s content. Backing up that serious commitment to healthy exercise is an expertly crafted menu that is part high-end, gluten-free, organic, locally sourced artistry, engineered to woo parents back time and again – and part delicious kids meal foods that are secretly packed full of healthy ingredients. By tricking kids into eating healthy through clever culinary techniques, like pureeing vegetables that kids otherwise stamp their feet about into a delicious and healthier pizza sauce, or using other similar techniques, Giggles N’ Hugs has assembled a wow-factor menu that will tantalize tykes, while allowing Mom and Dad to rest assured that they are establishing good eating habits.

As the kids grow up, they will come to realize the difference between the high-quality, organic, locally sourced pizza and other foods they have been eating at Giggles N’ Hugs and the kind of fare they might get from a Domino’s Pizza (NYSE: DPZ) or Yum! Brands’ (NYSE: YUM) Pizza Hut. This subtle redefinition of a beloved kids dish like pizza, around a healthier standard, is the kind of life lesson that will really stick with a kid as they mature, impressing upon them that their favorite foods don’t have to be unhealthy. More to the point, it will impress upon them the idea that healthy food can be delicious and fun at the same time, allowing them to feel good about healthy choices, and to more ably continue making healthy decisions on their own. Moreover, the clear and direct association between healthy eating and healthy play is made in such a natural way, it really sticks in the subconscious.

More and more parents are tuning in to health consciousness and demand is steadily increasing for precisely the kind of finely-tuned concept Giggles N’ Hugs represents. As the company moves to franchise out beyond its primary three locations in some of LA’s top shopping centers, a real healthy option when it comes to someplace to take the little ones to eat could soon be coming to towns all across America. Given that the company now offers extremely affordable all-day passes starting at $6 a child and that the locations are always staffed by highly-trained and professional employees who cater to and even dote on the children, Giggles N’ Hugs is the perfect additional venue for any mall or shopping center. Parents can drop the kids off to play and get the shopping done, before returning to have a meal with their young ones and returning home. It’s an appealing offer for busy moms, in particular, and could become a popular nationwide option as the franchise proliferates.

Needless to say, the lease space and conditions the company has access to as a result of its mall-enhancing profile are premium to say the least, and that fact should help to facilitate rapid expansion once the model starts to crop-out beyond LA. As it stands though, the company is already on very solid footing, with its flagship location in Century City’s Westfield Mall, and two other locations at the Glendale Galleria and Westfield Topanga Shopping Center (Woodland Hills), doing exceptionally robust turnover business. This is especially true when it comes to the themed birthday parties that the company goes to great lengths over, with each party being tailored to the individual boy or girl for whom it is thrown. Birthday parties have become a revenue staple for the company and this is a growth market for GIGL, with a best-in-class set of offerings for parents that pack more bang for the buck than any competitor on the market today. And these parties come complete with all the amenities, from gift bags, themed desserts, decorations, and the usual assortment of fun activities, like karaoke, scavenger hunts, or arts and crafts, which are available every day at Giggles N’ Hugs – to costumed staff playing the part of the child’s favorite superhero.

The writing is on the wall when it comes to continued upside for companies that are able to really tap in to the clean food trend and get a stranglehold on the zeitgeist the way GIGL has. Not only has this company essentially created the first organic, upscale casual dining restaurant that is totally comfortable for both under 10’s and their parents, the company is in a prime position to franchise its brand nationwide, and has the industry contacts with the big shopping center owners which are needed to follow through.

This idea and the company itself are still small enough for any investor to put down roots. It is a potential goldmine when you consider we could be looking at the next McDonald’s (NYSE: MCD), especially since this is a model you can really feel good about. Pretty safe to say there won’t be any high profile PR disasters for GIGL about food quality to weigh down the share price long-term, either.

Learn more by visiting www.gigglesnhugs.com

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When Oakridge Global Energy Solutions, Inc. (OTCQB: OGES) transitioned from a true R&D company to the only U.S. manufacturer of lithium-ion batteries in just 18 months, you knew it was on to something great. It seems these days that there’s a special kind of energy emitting from the company’s $40 million, 70,000-square-foot manufacturing plant in Palm Bay, Florida – and it’s not just coming from its lithium-ion battery cells.

The company’s ‘energy’ production, which is delivered by way of its manufacturing of lithium-ion large format prismatic cells, small format prismatic cells, and battery modules, meets the energy requirements of those who work hard, day in and day out, and choose to spend their coveted rest and relaxation time on golf carts, boats, recreational vehicles and motorcycles. Today, this pipeline comprises sales orders exceeding $20 million and showing no signs of letting up.

OGES is positioned as a leader in the innovation and manufacturing of disruptive energy storage technology for military, civilian and medical uses. The company’s research, development and marketing efforts have brought to market some of the world’s longest-lasting rechargeable power sources, available today by way of a battery life tripling that of its foreign competition.

The company’s mission is to be recognized by its customer base as ‘the premier and most broadly capable battery manufacturing company’. OGES has its intellectual energy focused on building an industrial scale platform to deliver innovation and provide world-class quality, delivery, service, and value through continual improvement in all of its endeavors. Company management seeks to positively impact the community and use its marketing and intellectual know-how to advance growth while simultaneously raising shareholder value.

Oakridge Global Energy Solutions, Inc. is a development stage company offering energy storage solutions in the United States. Its core products include lithium-ion large format prismatic cells, small format prismatic cells and battery modules. Distribution efforts are accomplished by way of a preliminary sales team. Incorporated in 1986, the company is headquartered in Palm Bay, Florida.

For more information, visit www.oakridgeglobalenergy.com

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American Pet Products Association (APPA) data forecasts that Americans will spend upwards of $62.75 billion on their pets this year (http://dtn.fm/n76B4), with the supplies segment continuing to rank a close third, just behind veterinary care and food, at around 23.8 percent of the pie. With nearly 163 million cats and dogs alone occupying households and hearts throughout this great country, the consolidative forces within the pet supply industry that sparked merger talks between the two biggest players recently, privately-owned (CVC Capital Partners and the Canada Pension Plan Investment Board) PETCO and PetSmart, are quite easy to understand. There is a massive, steadily growing market out there to be tapped and the domestic pet store industry, which has grown to some $18.5 billion in revenues as of this year and which is on track to grow by just over three percent per annum through 2021, has become fiercely contested territory.

The aforementioned merger talks may have collapsed under the pressure of scrutiny from U.S. antitrust regulatory authorities, but that collapse merely set the stage for the $8.7 billion leveraged buyout of PetSmart (again via private equity, this time led by BC Partners). Any savvy investor can smell the opportunity here, especially for what an IBIS World report out earlier this year explained as the hottest segment moving forward: premium products and services. Another recent report, this time by Packaged Facts from late 2015, sees the overall pet industry growing to nearly $92 billion in sales by 2019, and affirms the general consensus about high-income households being a major demographic for pet product brands.

Little surprise then in all of this market momentum that innovative developer of high-quality, super-premium pet toys and accessories, OurPet’s Company (OTCQX: OPCO) has continued to wow investors with its bottom line performance metrics. A combination of ingenious product development/design, guided by a deep management bench of industry veterans, and pitch-perfect product execution when it comes to the interests of its core markets, has collectively buoyed the company’s net income and revenue performance. Amid boisterous consumer activity, as people continue to respond strongly with positive feedback to the company’s newest designs, OPCO’s raw financial performance has climbed to levels surpassing even the company’s own previous YOY records set in Q4 2015 (ended December 31). For Q1 2016 (ended March 31), OPCO posted handsome net revenue gains of 10.3 percent compared to Q1 2015, and a whopping 24.7 percent increase in net income over the same interval.

Primary driving force behind the company’s ever-growing portfolio of lovingly engineered pet products, Dr. Steve Tsengas, was keen to point out the company’s marketing efficacy at the time of the Q1 financials release. Noting in particular how good for business the Q1 kick-off every year of OPCO’s newest offerings was, done via the widely-attended international trade show presented by the APPA and Pet Industry Distributors Association in Orlando, Florida, known as the Global Pet Expo. Dr. Tsengas’s multi-decade quest to bring the power of his vast experience in holistic, integrated and naturopathic health to the development of high-end, signature pet brands, is really starting to pay off for shareholders nowadays. What with the successful introduction this year of the company’s Intelligent Pet Care™ line, featuring BlueTooth® and wireless connectivity, for its SmartScoop® – Intelligent Litter Box, SmartLink™ Feeder – Intelligent Pet Bowl, and SmartLink™ Waterer – Intelligent Water Fountain.

The debut of other products, like the company’s 100% Natural Switchgrass BioChar litter, further enhances its growing brand presence among those key high-income households that every product developer today is trying to court. And OurPet’s Company has a thriving online ecommerce presence, both via its own site and ecommerce giants like Amazon, where the company’s products typically have superb reviews/ratings from customers.

While small physical operators in the industry continue to come under fire from big-box specialty stores, the industry continues to consolidate and more of the retail transactions migrate to digital (with mobile leading the way), a company like OPCO is supremely well-positioned to profit through a tight mix of killer designs that have lasting brand/product appeal. Appeal that is based on robust materials, intelligent engineering, and a deep-seated need to understand the psychology of pets, so that products can be made to enhance the lives of what are for most households just another beloved member of the family.

For more information, visit the company’s website at www.ourpets.com

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Laguna Blends Inc. (OTC: LAGBF) is a relatively new multi-level marketing (MLM) company that focuses on generating sales of functional, hemp-based beverage products. LAGBF was formed in 2014 and has seen tremendous growth since then. Stuart Gray, CEO of Laguna Blends, owns 18.5 percent of the outstanding shares. The company currently offers two hemp-based functional beverages: Caffe and Pro369. Although the market is relatively young, Laguna Blends chose the hemp market because it offers multiple health benefits to its users. Hemp, a member of the cannabis family, is receiving focus because of its potential use in health foods and functional foods. The plant is a great source of protein, fatty acids, magnesium, zinc, and many other vital nutrients. LAGBF operates using white label independent sellers to distribute its products. It launched its sales on March 2016 with 135 affiliates, and its network has grown to include more than 700 independent sellers today.

Fundamental Research Corp. (FRC) has recently initiated coverage on LAGBF. FRC has been providing quality equity research coverage since 2003. The firm’s research has covered more than 250 small and micro-cap public companies, and it has helped some of the largest institutional investors in the world choose the direction of commodity prices and top stock picks. The report on LAGBF was released on May 5, 2016, and gives Laguna Blends a BUY rating and a fair value estimate of $0.45 per share. The report on Laguna Blends includes an overview of LAGBF as it stands today, information on MLM, the hemp industry, the functional food and beverage industry, and Laguna’s current position within these on a financial level. The report also provides predictions for Laguna on what is to come, giving investors an educated insight into what the company has to offer moving forward.

FRC’s study gives Laguna Blends a BUY rating, as the company is expected to start reporting sales figures in the near future. Fundamental Research Corp. also believes that value proposition and market absorption will play a key role in attracting affiliates. The research firm believes LABGF’s long-term success is directly linked to the company’s ability to attract new affiliates. LABGF’s forecast for 2020 is based on the assumption it will have 24,000 affiliates, granted it keeps introducing new products. The expected return for the vitamins and nutritional supplements industry is a healthy 10.2 percent.

According to FRC’s report, the cost of the company’s shares will range from $0.30 to $1.06, depending on the number of affiliates Laguna Blends has by 2020 (ranging from 12,000 to 100,000). Although the Risk Rating Laguna Blends received is a four (meaning the company may be a start-up or in a turn-around situation), it still received FRC’s highest Equity Rating (BUY) and is expected to have a return of 12 percent or more.

For more information, visit www.lagunablends.com

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Excitement surrounding the Internet of Things (IoT) has been building for nearly a decade, but the time has come for a more connected world to truly take shape. According to a report by Adobe, the amount of Internet-connected things will reach 50 billion by 2020, offering profits and cost savings to the tune of $19 trillion (http://dtn.fm/7tNTM). Among this growth, smart devices within the home, such as thermostats and kitchen appliances, are expected to contribute about $490 billion by 2019, led by established names in the tech sector such as Google (NASDAQ: GOOG), which bought smart thermostat maker Nest in 2014 (http://dtn.fm/2B2lu), and Samsung (OTC: SSNLF), which acquired connected home company SmartThings (http://dtn.fm/4HDe2) later that same year.

Despite the strong performance of IoT in the consumer space, the primary destinations for smart devices are healthcare and manufacturing. By 2025, Adobe estimates that the value of IoT technology in the healthcare industry could exceed $2.5 trillion. While this is big news for players in the healthcare space, it also presents an opportunity for companies with innovative ideas operating in other sectors. One such company is OurPet’s Company (OTCQX: OPCO), a leading designer, producer and marketer of innovative pet products in the U.S. and overseas. Taking its cue from the success of IoT in the healthcare industry, OurPet’s recently introduced a new line of pet products that leverages Bluetooth and wireless connectivity to monitor various activities that can be interpreted as indicators of pet health.

OPCO’s Intelligent Pet Care™ product line includes three products designed to bring pet ownership into the 21st century, including the SmartScoop® – Intelligent Litter Box, the SmartLink™ Feeder – Intelligent Pet Bowl and the SmartLink™ Waterer – Intelligent Water Fountain. With these products, pet owners can monitor pets’ drinking, feeding and elimination behavior directly from their smartphones and other mobile devices. This feedback is critical, because irregularities regarding any of these behaviors can, in some cases, be a sign of potential health issues. In the case of excessive drinking, for example, dogs may be reacting to an accumulation of harmful substances in the body, which can be the result of infections, diabetes or kidney failure (http://dtn.fm/8Aj1F).

The benefits of IoT technology in the healthcare space have been clearly demonstrated by its widespread adoption in recent years. OPCO’s new Intelligent Pet Care™ product line opens the door for the roughly 65 percent of U.S. households that own a pet (http://dtn.fm/PER2o) to follow the healthcare industry’s lead while promoting the enhanced health and wellness of their furry family members.

“The pet industry is continually evolving and it’s our goal to introduce new products every year that improve the health, safety, comfort and enjoyment of pets, which in turn strengthens the bond between pet and pet parent,” Dr. Steven Tsengas, chairman and chief executive officer of OPCO, stated in a news release. “These [Intelligent Pet Care™] products enhance the convenience of pet ownership and the connectivity between pets and pet owners by monitoring various activities that can be interpreted as indicators of pet health, such as drinking, feeding and elimination behavior.”

For more information, visit the company’s website at www.ourpets.com

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The proliferation of the internet over the past decade has had an undeniable effect on the global travel industry. In 2007, total online travel sales were estimated at just $93.8 billion, according to data from Statistic Brain (http://dtn.fm/G8uxx), but just five years later, the industry had grown to roughly $162.4 billion in sales. Today, approximately 148 million travel bookings are made on the internet each year, accounting for about 57 percent of all travel reservations. While air ticketing and packaged tours account for a healthy percentage of this revenue, the lion’s share is attributed to hotel and accommodation reservations. Led by industry giants such as Priceline (NASDAQ: PCLN) and Expedia (NASDAQ: EXPE), this rapid growth has shown little signs of slowing down.

As with any rapidly growing market sector, the online travel agency space has seen its fair share of consolidation over the years. Way back in July 2005, Priceline acquired European hotel booking site Booking.com before expanding its profits from $10 million to about $1.1 billion in less than a decade (http://dtn.fm/j1idK). In 2012, the company attempted to catch lightning in a bottle again when it purchased Kayak Software Corp. in an effort to fend off growing competitors and increase its customer base (http://dtn.fm/S7ljX). Last year, Expedia followed suit, acquiring both Orbitz and Travelocity over the course of a few weeks (http://dtn.fm/2OppD).

While the referenced consolidation examples point to a common theme of established players acquiring rivals with expansive and valuable user bases, recent market action has suggested that there’s more to an online travel platform than its market share. Just last month, TripAdvisor (NASDAQ: TRIP) made headlines when it acquired London-based vacation rental service HouseTrip for an undisclosed amount (http://dtn.fm/YO3g9). Unlike the acquisitions mentioned above, HouseTrip’s financial position and user base were both fairly underwhelming. Since its launch in 2009, the site generated only eight million bookings, while primary competitor Airbnb is on pace to help host an estimated 129 million guests this year alone.

With HouseTrip’s small market share, its acquisition by TripAdvisor may seem puzzling, at least until viewed from the angle of inventory. As travel industry leaders attempt to replicate the success of Airbnb’s sharing economy business model, companies boasting sizable property inventories are becoming prime acquisition candidates. Through the acquisition of HouseTrip, TripAdvisor added an estimated 130,000 properties to its family of booking platforms (http://dtn.fm/Beji6), bringing the company’s total listings to nearly 800,000 unique properties in high-demand markets around the globe.

The success of Airbnb has many in the travel industry playing catch-up, but one company has its sights set on the next big thing in vacation accommodation. Monaker Group, Inc. (OTCQB: MKGI), a technology driven travel company with multiple divisions and brands, recently announced the launch of its proprietary timeshare booking engine, NextTrip Resorts. Through this groundbreaking platform, Monaker is targeting a largely untapped market with inventory of about 19 million rooms, of which roughly 25 percent go unused. To date, the company has added over 250,000 units of alternative lodging inventory to its flagship NextTrip.com booking platform, and it reports approximately one million total alternative lodging units currently under contract.

With the travel industry’s recent track record of rapid consolidation, Monaker’s sizable property inventory and growing user base position it as a potentially high-value candidate for industry leaders in search of the next big thing. Look for the company to leverage this momentum as it continues to expand upon its position at the forefront of the alternative lodging space. With one of the largest inventories of alternative lodging properties in the industry (http://dtn.fm/WAef5) and innovative new features such as real-time booking solutions, Monaker is a company that’s worthy of serious consideration from prospective shareholders in the months to come.

For more information, visit www.monakergroup.com

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Before the opening bell, Content Checked Holdings, Inc. (OTCQB: CNCK) announced a new strategic partnership with ATLETO, a social sports app that connects everyday athletes. Through this agreement, the two companies will engage in a cross-promotional marketing campaign designed to highlight their apps as platforms for helping users accomplish their health and fitness goals. Moving forward, Content Checked will leverage its social media presence to promote and endorse ATLETO while encouraging downloads and driving brand awareness. Similarly, ATLETO will support Content Checked with promotional posts across all of its social channels, effectively increasing the visibility of Content Checked’s innovative suite of mobile apps amongst everyday athletes.

“Partnering with ATLETO is a natural fit since its platform aligns with our philosophy of fostering a community of like-minded individuals who commit to bettering their lives,” Kris Finstad, co-founder and CEO of Content Checked, stated in this morning’s news release. “We want to educate our audience and introduce them to platforms developed to help users make healthier choices easily, and we happily promote everything ATLETO stands for.”

The ATLETO app is designed to help athletes connect with other users based on location, skill level and frequency in order to improve their athletic experiences. Available on Apple’s App Store, ATLETO is capable of matching users with new and existing friends who are interested in similar sports, including popular sports such as basketball, golf, soccer, tennis and volleyball, as well as fitness and workout activities like cycling, running and yoga. ATLETO is currently in the midst of a marketing campaign focused on developing a user base in Los Angeles, Miami and New York City. By partnering with the social sports app, Content Checked stands to benefit from these efforts.

“Content Checked’s technology has significantly improved the health of individuals and we aim to provide such a significant impact to our own community of athletes,” Peter Dalgas, co-founder and CMO of ATLETO, stated in this morning’s news release. “Our complementary visions create a symbiotic relationship and we’re eager to share with our community the benefits of Content Checked’s family of apps.”

In recent weeks, Content Checked has turned to strategic partnerships with like-minded organizations as a way to increase its brand recognition. In February, the company teamed with Kitchology, Inc., a mobile platform that provides tailored recipes to consumers with special dietary needs, and gained access to its database of recipes modified to meet the needs of consumers with dietary restrictions or allergies. Last month, Content Checked teamed with Leaner Creamer, the only all-natural powdered coffee creamer that promotes weight loss and appetite suppression, for a cross-promotional marketing campaign aimed at elevating both parties among health-conscious audiences.

For more information, visit www.contentchecked.com

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Laguna Blends, Inc. (OTC: LAGBF), a network marketing company focused on generating sales of its hemp-based functional beverages through independent affiliates, today announced that it has engaged the Corporate Communications Services of QualityStocks. Based in Scottsdale, Arizona, QualityStocks has assisted more than 300 public companies with their efforts to broaden influence, attract growth capital and improve shareholder value over the past 10 years.

“With the commercialization of our unique, hemp-based beverage products, Laguna Blends is strategically positioned to capture market share in two high-demand markets,” says Laguna Blends CEO Stuart Gray. “As we expand this product line and grow our team of independent sales affiliates, it’s vitally important that we keep shareholders in the loop of our achievements. Working with QualityStocks enables us to continue this growth pattern while fine-tuning our communications strategies.”

QualityStocks will strategically leverage its network of partners, daily and weekly newsletters, social media channels, blog and other outreach tools to enhance Laguna Blends’ transparency and brand visibility with the investment community.

“Our objective is to enable Laguna Blends to strengthen its communication initiatives without slowing its pace in terms of growing its sales network, expanding its product line, and building corporate value,” says QualityStocks Managing Director Michael McCarthy. “The QualityStocks team will work closely with Laguna Blends to make sure its corporate message is strong, consistent and visible to both existing and potential shareholders.”

For more information, visit www.lagunablends.com

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Momentous Entertainment Group (OTC: MMEG) charts its course as an entertainment and direct response marketing company with a focus on developing, producing, and distributing content. The company sells entertainment and consumer products through a distribution channel and uses direct response media marketing – the art of evoking an immediate response and driving prospective customers to take some type of specific action, such as adding one’s self to an email distribution list or making a phone call.

As the company develops its sales and distribution channels, Momentous plans to build out its music division along with its feature film, television production, and finance divisions. Boasting a combined total of over 100 years of entertainment and marketing experience, the company plans to make contributions by delivering content and products on a global scale. MMEG is in the process of developing a portfolio of family entertainment and unique merchandise to distribute worldwide.

MMEG is energized with its progress through differentiation within the direct response industry. This upward trending and masterfully effective approach is made up of direct response television, radio marketing, home shopping channels, catalogs, direct mail, advertising and internet marketing. In addition, outbound telemarketing weighs in as a vital piece of one of the fastest growing segments of the retailing industry. Advertising in the consumer product marketplace has long achieved great success with infomercials and intriguing cross-selling and up-selling strategies.

The Direct Marketing Association has reported that total sales from direct response television (DRTV) trended toward nearly $400 billion in 2014 while demonstrating signals of sustainable growth with repeatable success rates. Using this data as a basis for growth expectations, the company could be able to gain a notable slice of market share using its unique marketing concepts put in place by team of direct marketers loaded with years of expertise.

The company’s entertainment division develops and produces quality life and faith oriented reality TV shows, documentaries, dramas, and feature films, with positive images and spirited stories with moral value messages. MMEG mirrors people’s experiences and uses them as the centerpieces of their stories to portray realistic ways to celebrate the significance and virtue of a faith-based life and existence.

For more information, visit www.momentousent.com

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On March 7, 2016, International Stem Cell Corporation (OTCQB: ISCO) announced that the Melbourne Health Human Research Ethics Committee (HREC) had approved its application to initiate phase I clinical trials of ISC-hpNSC® (human parthenogenetic neural stem cells) for the treatment of moderate to severe Parkinson’s disease. With that approval, ISCO has begun enrolling patients for those phase I clinical trials in what marks a major milestone for the company.

International Stem Cell Corporation is researching new ways to increase the quality and length of human life spans through regenerative technologies that augment or replace organ transplants, developments made possible by the discovery of the structure of deoxyribonucleic acid (DNA) in 1953 by American biologist James Watson and English physicist Francis Crick. DNA was first identified (http://dtn.fm/Elyc9) by the Swiss physiological chemist Friedrich Miescher in 1869. The knowledge that the DNA molecule exists in the form of a three-dimensional double helix has been hailed as one of the ‘two radical developments over the past sixty years’ in medicine in What Happened to the Future (http://dtn.fm/FqxA9), a lament on the slow pace of present technological development.

The What Happened to the Future jeremiad penned by the venture capitalist Bruce Gibney while at Founders Fund tells how it used to be. ‘Less than twenty-five years after Watson and Crick published the structure of DNA, venture capitalist Robert Swanson and biochemist Herbert Boyer founded Genentech, now a subsidiary of Roche (OTCQX: RHHBY), which went on to synthesize insulin far faster and more cheaply than almost anyone believed possible. And in a great revolution in the FDA approval process in the 1980s following pressure from the AIDS lobby, the agency acted almost nimbly to approve a huge number of important new drugs for many maladies.’

However, since then the drug development process has become notoriously tortuous and costly. It starts with drug discovery, when new insights into how a disease progresses allow researchers to design a product to stop or reverse its effects. Alternatively, a number of molecular compounds may be tested to determine what effect, if any, they may have against a range of medical conditions. Sometimes, good fortune may come of the ubiquitous side effects. A drug prescribed for one condition may be found to have benefits in other areas. And then, of course, there are the new technologies like ISCO’s human parthenogenetic stem cell (hpSC) technology.

After a particular compound has been identified, it must be subjected to pre-clinical trials. Pre-clinical trials, or, as they are sometimes called, non-clinical testing, may be pharmacodynamic (examining what the drug does to the body); pharmacokinetic (examining what the body does to the drug); may examine how the compound is absorbed, distributed, metabolized and excreted by the body; or may attempt to determine its toxicity. In some instances, animals may be employed in pre-clinical trials.

It is only after greater knowledge of the compound has been obtained through pre-clinical testing that it will be administered to humans in clinical trials. Clinical trials typically may have four phases, each of which is designed to answer a research question. In phase I, researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. This is the point that ISCO has reached with its human parthenogenetic stem cell ISC-hpNSC® technology.

In phase II clinical trials, the compound is given to a larger group of people to see if it is effective and to further evaluate its safety. In phase III studies, the drug is administered to an even larger group of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. Phase IV testing is conducted after the drug has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.

Before a drug can be marketed, it will be reviewed by the FDA when the sponsoring company submits a new drug application (NDA). And for many years to come, the FDA will continue its post-market safety monitoring. It’s quite a journey for a drug discovery company to take, but mindful of Gibney’s complaint, International Stem Cell Corporation is forging ahead with the phase I trials, which will be performed at the Royal Melbourne Hospital in Australia.

For more information, visit www.internationalstemcell.com

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