GSAE, KBLB, APDN, BBYB, ADVE
KERX, EPEX, OSCI, BVTI, NVSR, UNCO
Our Stocks to Watch today include Green Star Alternative Energy Inc. (OTC: GSAE), Kraig Biocraft Laboratories Inc. (OTCBB: KBLB), Applied DNA Sciences Inc. (OTCBB: APDN), Baby Bee Bright Corp. (OTC: BBYB), Adventure Energy Inc. (OTCBB: ADVE), Keryx Biopharmaceuticals Inc. (Nasdaq: KERX), Edge Petroleum Corp. (Nasdaq: EPEX/EPEXP), Oscient Pharmaceuticals Corp. (Nasdaq: OSCI), Biovest International Inc. (OTC: BVTI), NavStar Technologies Inc. (OTC: NVSR) and Unico Inc. (OTCBB: UNCO).

FEATURED
COMPANY

GREEN STAR ALTERNATIVE ENERGY INCORPORATED (OTC: GSAE)
"Up 4.44% in morning trading"
Detailed
Quote: www.otcpicks.com/quotes/GSAE.php
Company
Profile: http://www.otcpicks.com/Newsletter/GSAE_eProfile_091708.htm
Green Star Alternative Energy is an environmentally conscious, renewable energy producer. The Company is working to develop more than 300 MW (megawatts) of clean electricity through wind energy. The corporate revenue model is two-fold: the use of a renewable resource allows not only for the creation of environmentally friendly energy, but the granting of carbon (greenhouse gas) emission credits which may be traded and sold. Green Star is pursuing a significant opportunity to provide clean energy to the growing Republic of Serbia and neighbouring European countries. Through a joint venture with key wind farm and power trading company Notos, Green Star will become the nation's first developer of wind power. GSAE is focussed on green technology and sustainable energy programs like wind turbines, hydro electric power generation, and other renewable electricity models.
GSAE News:
June 1 -
Green Star/Notos JV Signs Agreement With City of Titel
Green Star Alternative Energy, Inc. (OTC: GSAE) ("GSAE" or the "Company") announced the signing of an agreement between the Green Star/Notos JV and the Municipality of Titel. The arrangement allows Green Star to explore the economic viability of the regional wind resources; and upon evaluation, the right to develop wind power and supply the area with clean electricity.
The Municipality of Titel is located in the South Backa District of the Autonomous Province of Vojvodina, Republic of Serbia. The current population is approximately 17,000 people. Titel is of significant interest to Green Star because of its geographical location. Its proximity to the famous Titelski Breg -- the location with the highest number of wind hours in the entire Balkan region — provides for major wind power potential. Green Star will raise its wind sensor towers in the municipality during the third quarter of this year.
Director of the Energy Department - City of Titel, Stevan Gecevski, stated: "As an underdeveloped municipality, we need companies like Notos who will raise standards and open our region for further investment and development. We appreciate their efforts and will provide uncompromising cooperation to assist Green Star and Notos in achieving their goals. We will expedite the process with support and any necessary licensing."
Miodrag Andric, CEO of Green Star Alternative Energy, stated: "We wish to help areas in need, and Titel is one of them. We all agree that there is great potential for developing wind power in this region, and together we will do our utmost to make that happen."
FEATURED
COMPANY

KRAIG BIOCRAFT LABORATORIES INCORPORATED (OTCBB: KBLB)
"Up 20.00% in morning trading"
Detailed
Quote: http://www.otcpicks.com/quotes/KBLB.php
Company
Profile: http://www.otcpicks.com/kraig-biocraft-laboratories/kraig-biocraft-laboratories.htm
Kraig Biocraft Laboratories, Inc. focuses on the development of protein based fiber using recombinant DNA technology for commercial applications in the textile and specialty fiber industries. Its products are used in military and police departments; industrial applications, including critical cables and abrasion/impact resistant components; and consumer applications. These fibers are also employed in safety equipment, and high strength composite materials for the aero-space industry. The company was founded in 2006 and is based in Lansing, Michigan.
KBLB
News:
May 29 - Kraig Biocraft Laboratories, Inc. Issues Stock Dividend
Kraig Biocraft Laboratories, Inc. (OTCBB: KBLB) announced that it has successfully issued its stock dividend. “The issuance of the dividend has been in the planning for some time and has been an important part of the Company's plan for returning value to our shareholders. Just as important, we believe that the issuance has laid the groundwork for the Company's long term future,” said CEO Kim K. Thompson. “The input we have received from our shareholders throughout this process has been and continues to be overwhelmingly positive. We are also very excited about the progress in the laboratory and are very hopeful that the scientific team can maintain their tremendous forward momentum through the summer and fall and into 2010.”
Kraig is working to develop and commercialize high performance polymers using spider silk gene sequences. The company plans to tap into the $92 billion market for high performance and technical fibers. In 2007 Kraig Biocraft Laboratories signed an intellectual property and collaborative research agreement with the University of Notre Dame. Since that time the Company has been a proud sponsor of scientific research and development within the university.
May 28 - Publisher's Note on Stock Dividend
Stock dividend shares for KBLB should have been issued today by the company via DTC. We spoke to our broker and they said, in our case, that the expected arrival date of the shares might be as late as June 2nd. So if your shares don’t arrive in your account today, do not worry. They should be on their way.
FEATURED
COMPANY

APPLIED DNA SCIENCES INCORPORATED (OTCBB: APDN)
"Up 5.45% in morning trading"
Detailed
Quote: http://www.otcpicks.com/quotes/APDN.php
Company
Profile: http://www.otcpicks.com/applied-dna-sciences.htm
APDN sells patented DNA security solutions to protect products, brands and intellectual property from counterfeiting and diversion. SigNature DNA is a botanical mark used to authenticate products in a unique manner that essentially cannot be copied. APDN also provides BioMaterial GenoTyping(TM) by detecting genomic DNA in natural materials to authenticate finished products. Both technologies protect brands and products in a wide range of industries and provide a forensic chain of evidence that can be used to prosecute perpetrators.
APDN
News:
May 28 -
Applied DNA Sciences Uses DNA Authentication to Safeguard Premium Wine Against Counterfeiting and Fraud
Applied DNA Sciences, Inc. (OTCBB: APDN), a provider of DNA-based security solutions, announced that it is using its patented and proprietary DNA authentication to help premium wine producers in their fight against fraud and counterfeiting. With counterfeit wines estimated to account for as much as five percent of the secondary market (Wine Spectator 2009), vintners need new technologies that allow them to easily validate the authenticity of their products. Along with more traditional chemical assays, DNA authentication is increasingly being accepted as a method to verify the authenticity of wine.
Wine fraud typically takes the form of counterfeit labels. Some producers attempt to reduce fraud by marking future vintage bottles with engraved serialized numbers, however, the counterfeiters have still been able to defraud older vintages and taint genuine products with poorer substitutes.
APDN has now completed a number of feasibility studies involving the application of complex botanical SigNature DNA® markers onto premium wines. The host for the DNA marker may be the label, the cork, or the bottle itself. These markers can be instantly screened using handheld readers, while the identity of the bottle may be proved forensically by DNA analyses. The DNA markers produced by APDN are unique, non-replicable and have false positive rates of less than one in a trillion. This enables producers to effectively implement a protection strategy that assures the long term security of their products and brands.
Another common method of wine fraud is the practice of blending inexpensive wine with more expensive wine or other materials and selling it at the higher price. APDN has developed methods to help counteract these activities, by allowing vintners to verify the contents of the wine by the genetic provenance or "BioMaterial Genotype" of a specific grape cultivar. Both methodologies can help the brand owner or vintner definitively verify both the internal and external contents of the wine, offering a complete system for authentication.
For centuries, most wineries made little effort to ensure their wines could not be faked. Wine fraud and counterfeiting has grown large enough that the FBI's art fraud squad is investigating. A spate of highly publicized incidents recently brought this crisis to public attention. In 1998, bottles of 1990 Penfold's Grange were revealed to be counterfeit, exhibiting typographical errors and inconsistent printing. Approximately 16,000 bottles of Sassicaia, retailed at $100 to $125 a bottle, were identified as fake and seized in Italy in 2000. Perhaps the most renowned and shocking counterfeiting scandal came to light in 2007, when a lawsuit brought by billionaire wine collector William Koch sparked a widespread federal investigation of several notable auction houses, wine collectors, and importers.
But now, concerned that customers will lose confidence and stop buying, wineries from Napa Valley, Long Island, Bordeaux, Tuscany and even the Barossa Valley in Australia, are exploring ways to make sure future bottles and their contents can be authenticated.
"Consumer confidence is eroded each time a story about fake goods is published. More and more, brand owners are recognizing that counterfeiting is a worldwide problem that needs to be immediately addressed by every business, in every market. DNA can help wineries protect their products and assure their customers of the authenticity of their high value investments without affecting the character of the finished product," stated Dr. James Hayward, CEO of APDN.
FEATURED
COMPANY

BABY BEE BRIGHT CORPORATION (OTC: BBYB)
Detailed
Quote: http://www.otcpicks.com/quotes/BBYB.php
Company
Profile: http://www.otcpicks.com/baby-bee-bright/baby-bee-bright.htm
Baby Bee Bright Corporation manages the Baby Bee BrightTM brand. Its executive staff, composed of professionals with over 30 years of experience in engineering research and marketing, have developed an innovative prenatal communication system, servicing the rapidly expanding expectant mother/prenatal market. The company has a patented, audio directional technology for its communicator which is designed for expectant mothers to safely and efficiently transmit music and sound to their babies. It allows mothers and family to bond with their babies before birth. Lullabies and classical music provide the baby with soothing sounds before and after birth.
BBYB News:
May 27 -
Baby Bee Bright Corporation Shareholder's Update No. 2
Baby Bee Bright Corporation (OTC: BBYB), developer of a unique prenatal communication system, is diligently working to meet the requirements for sales, both retail and wholesale. Initial materials are being ordered and should be arriving in the first few weeks of June.
CEO Fred Dahlman states, “We at Baby Bee Bright continue to be energetic with our plans to move forward with sales. We’re working to obtain the necessary supplies to get our products to the public. It’s full speed ahead at Baby Bee Bright Corporation.”
FEATURED
COMPANY

ADVENTURE ENERGY INCORPORATED (OTC: ADVE)
Detailed
Quote: http://www.otcpicks.com/quotes/ADVE.php
Company
Profile: http://www.otcpicks.com/adventure-energy/adventure-energy.htm
Adventure Energy, Inc., is an independent energy company principally engaged in the acquisition, exploration and development of mature long-lived oil and natural gas properties. The company's current operations are concentrated in the Appalachian Basin within the states of Kentucky and West Virginia.
ADVE
News:
May 28 -
Adventure Energy Inc. Enters Into Letter of Intent to Acquire a 50% Working Interest in the Petrowarrior-Stout Recompletion Project in Oklahoma
Adventure Energy Inc. (OTCBB: ADVE), an energy exploration company with operations in the Appalachian Basin, announced that the Company has entered into a Letter of Intent with Buccaneer Energy to purchase a 50% working interest (39% net revenue interest) in the Petrowarrior-Stout recompletion project located in Pottawatomie and Seminole Counties, Oklahoma.
The project consists of 13 previously drilled and completed wells which will be reworked over the coming months and one water disposal well. Included within this project is the option to drill up to five (5) new wells on the leasehold acreage. The Company anticipates the rework project to begin before the end of June with the goal of completion over the next 9 months. The projected revenue stream from the first three (3) wells it is anticipated will fund the Company's remaining costs for this project.
“We are excited to have the opportunity to significantly increase our production at a time when commodity prices have shown a slight rebound in the business cycle. As the commodity prices improve, the project will prove to be an even more valuable acquisition,” said Wayne Anderson, President of Adventure Energy, Inc. “We continue to focus on increasing production capacity and we look forward to re-affirming Adventure's commitment to identify and negotiate attractive acquisitions of oil and gas properties with an exploitation upside.”
STOCKS
TO WATCH
KERYX BIOPHARMACEUTICALS INCORPORATED (NASDAQ: KERX)
"Up 68.57% in morning trading"
Detailed
Quote: http://www.otcpicks.com/quotes/KERX.php
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important, novel pharmaceutical products for the treatment of life-threatening diseases, including renal disease and cancer. Keryx is developing Zerenex(TM) (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. Zerenex is currently in Phase 2 clinical development for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease. The Company is also developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that modulates Akt, a protein in the body associated with tumor survival and growth. KRX-0401 also modulates a number of other key signal transduction pathways, including the JNK and MAPK pathways, which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 is currently in Phase 2 clinical development for multiple tumor types. The Company also has an in-licensing and acquisition program designed to identify and acquire additional drug candidates. Keryx is headquartered in New York City.
KERX News:
May 31 -
Keryx Biopharmaceuticals Reports Positive Data from a Randomized, Multi-Center, Placebo-Controlled, Phase 2 Combination Study of KRX-0401 (Perifosine) in the Treatment of Advanced Metastatic Colon Cancer
KRX-0401 + Capecitabine More Than Doubled Time to Progression and Overall Response Rate as well as Extended Overall Survival vs. Capecitabine + Placebo in Patients with 2nd or 3rd Line Metastatic Colon Cancer
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) announced data on the clinical activity of KRX-0401 (perifosine), the Company's Akt-inhibitor for cancer, in combination with capecitabine as a treatment for advanced colon cancer. Abstract #4081, entitled, "Randomized phase II study of perifosine in combination with capecitabine versus capecitabine alone in patients with second- or third-line metastatic colon cancer," is being presented today in a poster during the Gastrointestinal Cancer - Colorectal session at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place in Orlando, Florida.
In this randomized, double-blind, placebo-controlled study conducted at 11 centers across the United States, patients with 2nd or 3rd line metastatic colon cancer were randomized to receive capecitabine (Xeloda®), an approved drug for metastatic colon cancer, at a dose of 825 mg/m2 BID (total daily dose of 1650 mg/m2) on days 1 - 14 every 21 days, plus either perifosine or placebo at 50 mg daily. Treatment was continued until progression. The study enrolled a total of 38 patients, of which 35 patients were evaluable for response (20 patients on the capecitabine + perifosine arm and 15 patients on the capecitabine + placebo arm). The three patients not evaluable for response were all in the capecitabine + placebo arm; 2 patients were inevaluable due to toxicity (days 14, 46) and 1 patient was inevaluable due to a new malignancy on day 6.
The median prior treatment regimens was two, with prior treatment regimens as follows: 91% of the patients received prior FOLFIRI (Irinotecan + 5FU + Leucovorin); 74% prior FOLFOX (Oxaliplatin + 5FU + Leucovorin); 63% were previously treated with both FOLFIRI and FOLFOX; 77% received prior Avastin®; and 43% prior Erbitux®. Prior treatment with single agent capecitabine was excluded.
The primary endpoints of this study were to measure 1) Time to Progression (TTP); 2) Overall Response Rate (ORR), defined as the percentage of patients achieving a Complete Response (CR) or Partial Response (PR) by RECIST, and 3) Clinical Benefit Rate (CBR) defined as the percentage of patients on treatment for greater than three months with at least stable disease. Safety of perifosine + capecitabine vs. capecitabine + placebo in this patient population was evaluated as a secondary endpoint. Perifosine in combination with capecitabine was well tolerated with hand/foot syndrome (14%) and anemia (11%) as the highest reported grade 3/4 adverse events.
Perifosine + capecitabine more than doubled time to progression vs. capecitabine + placebo with a statistically significant p-value = 0.0006. In addition, perifosine + capecitabine more than doubled the ORR and almost doubled the Clinical Benefit Rate vs. capecitabine + placebo.
Dr. Howard Burris, Chief Medical Officer and Director of Drug Development for the Sarah Cannon Research Institute, Nashville TN, an investigator involved in the Keryx-sponsored perifosine clinical program since 2004, remarked, "The results demonstrate that the addition of perifosine to capecitabine more than doubled time to progression and response rates, along with extending survival vs. capecitabine alone. Although not a large sample size, the data here is very interesting and next steps should be considered."
Ron Bentsur, Chief Executive Officer of Keryx, commented, "Patients with advanced metastatic colon cancer, who fail standard first and second line treatment, are truly in need of additional therapies. We are excited about the data as the combination of perifosine and capecitabine, two oral agents, appears to demonstrate superior clinical benefit over capecitabine alone in this advanced patient population. We will now explore plans to move this program forward in patients with advanced colorectal cancer." Mr. Bentsur added, "We wish to thank all the study investigators for their dedication to this clinical trial."
A copy of abstract #4081 is currently available and can be viewed on-line through the ASCO website at www.asco.org. A copy of the poster may be obtained by contacting the Company.
ABOUT COLON CANCER
According to the American Cancer Society, not counting skin cancers, colorectal cancer is the third most common cancer diagnosed in the United States. It is estimated that 106,100 people will be diagnosed with colon cancer, 40,870 people will be diagnosed with rectal cancer and approximately 50,000 deaths will be attributable to some form of colorectal cancer in 2009. Surgery is often the main treatment for early stage colon cancer. When colon cancer metastasizes (spreads to other parts of the body such as the liver) chemotherapy is commonly used. Treatment of patients with recurrent or advanced colon cancer depends on the location of the disease. Chemotherapy regimens (i.e. FOLFOX or FOLFIRI either with or without bevacizumab) have shown to increase survival rates for some stages of colorectal cancer. Currently, there are seven approved drugs for patients with metastatic colorectal cancer: 5-FU, capecitabine (Xeloda®), irinotecan (Camptosar®), oxaliplatin (Eloxatin®), bevacizumab (Avastin®), cetuximab (Erbitux®), and panitumumab (Vectibix®). Depending on the stage of the cancer, two or more of these types of treatment may be combined at the same time or used after one another.
EDGE PETROLEUM CORPORATION (NASDAQ: EPEX)
"Up 42.03% in morning trading"
Detailed
Quote: http://www.otcpicks.com/quotes/EPEX.php
Edge Petroleum Corporation is a Houston-based independent energy company that focuses its exploration, production and marketing activities in selected onshore basins of the United States. Edge common stock and preferred stock are listed on the NASDAQ Global Select Market under the symbols "EPEX" and "EPEXP" respectively.
EPEX
News:
May 8 - Edge Petroleum Announces Results For First Quarter of 2009
Edge Petroleum Corporation (Nasdaq: EPEX/EPEXP) reported financial and operating results for the first quarter of 2009 as follows:
* Production for the first quarter of 2009 was 3.1 Bcfe, averaging 34.5 MMcfe per day.
* For the quarter ended March 31, 2009, we recorded cash settlements paid by our counterparties on our derivative contracts totaling $5.9 million pre-tax. We also recorded a non-cash net unrealized pre-tax derivative gain of $5.2 million, which represents the change in the fair value of our derivative contracts between December 31, 2008 and March 31, 2009. These resulted in a net pre-tax derivative gain of approximately $11.1 million included in total revenue for the quarter ended March 31, 2009.
* We recorded an impairment of our oil and natural gas properties of $78.3 million in the first quarter of 2009 as a result of further declines in commodity prices.
* Our first quarter 2009 net loss to common stockholders was $76.9 million, or $2.74 basic and diluted loss per share. This loss reflects the impact of the $78.3 million impairment of our oil and natural gas properties that we recorded at March 31, 2009.
* On March 16, 2009, we entered into an amended Consent and Amendment No. 4 to our Revolving Facility (the "Amended Consent") which provides, among other things, that (i) we will make a $25 million payment on May 31, 2009 with all remaining principal, fees and interest amounts under our Revolving Facility to be due and payable on June 30, 2009, and (ii) that it will be an event of default if, among other things, by May 15, 2009 we have not either obtained a commitment sufficient to pay all of our obligations under the Revolving Facility or otherwise entered into a sale, merger or other business combination agreement that would result in the repayment of all of our obligations under the Revolving Facility on or before June 30, 2009. Primarily due to the uncertainty surrounding the significant payments due June 30, 2009 under our Revolving Facility, our independent auditors modified their opinion on our 2008 consolidated financial statements to include a going concern explanatory paragraph.
* We logged four wells during the first quarter of 2009 with three apparent successes. The non-operated Williams Fed A#8 (Edge W.I. 18.75%) in southeast New Mexico was recently completed in the Yeso formation producing approximately 20 Bbl per day of crude oil and 26 Mcf per day of natural gas. This well has apparent behind pipe pay in three additional shallower zones. In Arkansas, in the Fayetteville Shale project, the non-operated Barger #1-16H (Edge W.I. 3.91%) was recently completed with an eight stage fracture stimulation and was put to sales flowing at an initial rate of approximately 1 MMcf per day. Also in Arkansas, the non-operated Landberg #1-31H (Edge W.I. 7.97%) was drilled in the first quarter 2009 and should be completed soon. Lastly, in south Texas, the acquisition phase of the 120 square mile El Sauz 3-D project (Edge W.I. 50%) began on March 21, 2009 and is progressing as planned. The acquisition phase of this project is expected to be completed by late May 2009.
First quarter production for 2009 was 3.1 Bcfe as compared to 5.4 Bcfe for the same period in 2008. Normal production declines, asset sales completed during early 2008 and decreased capital re-investment in replacing production as compared to historical levels contributed to our overall production decline in the first quarter of 2009. We have been operating under a reduced reinvestment program while we have been engaged in our financial and strategic alternatives evaluation process.
We reported an increase in total revenue for the first quarter period of 2009 compared to the same period in 2008. Total revenue for the three months ended March 31, 2009 was $24.1 million compared to $17.7 million in the first quarter of 2008, an increase of 36%. Falling commodity prices in the first quarter of 2009 resulted in net gains on derivatives of $11.1 million to partially offset the losses experienced from our physical commodity sales. In the first quarter of 2008, however, we reported a loss on derivatives of $29.4 million.
Oil and gas operating expenses for the three months ended March 31, 2009 totaled $3.8 million compared to $4.5 million for the same period in 2008. Depletion costs for the first quarter of 2009 totaled $9.8 million and averaged $3.16 per Mcfe compared to $27.1 million and an average of $4.99 per Mcfe for the first quarter of 2008. At December 31 and September 30, 2008 we recorded non-cash full-cost ceiling test impairments on our oil and natural gas properties in the amounts of $233.3 million ($215.8 million net of tax) and $129.5 million ($84.2 million net of tax), respectively. If the 2008 impairments had not been taken, our depletion rate would have been approximately $6.40 per Mcfe at March 31, 2009 as compared to $3.16 per Mcfe. We recorded a net non-cash full-cost ceiling test impairment at March 31, 2009 of approximately $78.3 million, which we expect to impact our depletion rate in the second quarter of 2009. General and administrative ("G&A") costs, which include share-based compensation costs, for the first quarter of 2009 were $4.6 million, 13% higher than the comparable prior year period, primarily because of the costs of our ongoing financial and strategic alternatives process.
First quarter 2009 net loss to common stockholders was $76.9 million or $2.74 basic and diluted loss per share. The same period a year ago we reported a net loss to common stockholders of $18.2 million, or $0.64 basic and diluted loss per share. Basic weighted average shares outstanding increased to approximately 28.8 million for the three months ended March 31, 2009 from 28.6 million in the comparable 2008 period. The increase in shares outstanding was due primarily to the vesting of restricted stock units during 2008 and 2009.
For the three months ended March 31, 2009, net cash flow provided by operating activities was $9.8 million and net cash flow provided by operating activities before working capital changes was $7.4 million. For the three months ended March 31, 2008, net cash flow provided by operating activities was $21.4 million and net cash flow provided by operating activities before working capital changes was $28.5 million. See the attached schedule for a reconciliation of net cash flow provided by operating activities to net cash flow provided by operating activities before working capital changes.
Debt at March 31, 2009 was $234.0 million as compared to $239.0 million at December 31, 2008. Debt at March 31, 2009 and December 31, 2008 is presented as current due to changes in our maturity date as a result of our entering into the Amended Consent in connection with the borrowing base deficiency of $114 million created by the recent redetermination of our borrowing base.
OSCIENT PHARMACEUTICALS CORPORATION (NASDAQ: OSCI)
"Up 19.22% in morning trading"
Detailed
Quote: http://www.otcpicks.com/quotes/OSCI.php
Oscient Pharmaceuticals Corporation is a commercial-stage pharmaceutical company marketing two FDA-approved products in the United States: ANTARA® (fenofibrate) capsules, a cardiovascular product and FACTIVE® (gemifloxacin mesylate) tablets, a fluoroquinolone antibiotic. ANTARA is indicated for the adjunct treatment of hypercholesterolemia (high blood cholesterol) and hypertriglyceridemia (high triglycerides) in combination with diet. FACTIVE is approved for the treatment of acute bacterial exacerbations of chronic bronchitis and community-acquired pneumonia of mild to moderate severity. Oscient promotes ANTARA and FACTIVE through a national sales force calling on primary care physicians, cardiologists, endocrinologists and pulmonologists.
OSCI News:
May 22 -
Oscient Pharmaceuticals Receives NASDAQ Letter Regarding Delay in Filing Form 10-Q
Oscient Pharmaceuticals Corporation (Nasdaq: OSCI) has received notification from the Listings Qualifications Department of The NASDAQ Stock Market LLC that since the Company has not filed its Form 10-Q for the period ended March 31, 2009, the Company is no longer in compliance with Marketplace Rule 5250(c)(1).
The Company has 60 calendar days, or until July 20, 2009, to submit a plan to regain compliance. Following such submission, NASDAQ may provide the Company with up to 180 calendar days from the filing’s due date, or until November 11, 2009, to regain compliance.
If NASDAQ does not accept the Company’s plan to regain compliance, the Company will receive written notification of delisting from NASDAQ and at that time will be entitled to request a hearing before a NASDAQ Listing Qualifications Panel to appeal the NASDAQ decision.
The NASDAQ notice has no effect on the listing of the Company’s common stock on The NASDAQ Global Market at this time.
BIOVEST INTERNATIONAL INCORPORATED (OTCBB: BVTI)
"Up 83.67% in morning trading"
Detailed
Quote: http://www.otcpicks.com/quotes/BVTI.php
Biovest International, Inc. is a pioneer in the development of advanced individualized immunotherapies for life-threatening cancers of the blood system. Biovest is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc., (NASDAQ: ABPI) with its remaining shares publicly traded. Biovest has a foundation in the manufacture of biologics for research and clinical trials. In addition, Biovest develops, manufactures and markets patented cell culture systems, including the innovative AutovaxID™, which is being marketed as an automated vaccine manufacturing instrument and for production of cell-based materials and therapeutics. Biovest is currently completing a pivotal Phase 3 clinical trial for BiovaxID®, which is a patient-specific anti-cancer vaccine focusing on the treatment of follicular non-Hodgkin's lymphoma. BiovaxID has been granted Fast Track status by the FDA and Orphan Drug status by the EMEA.
BVTI
News:
May 31 -
Positive, Clinically Significant Phase III Results for Personalized Anti-Cancer Vaccine, BiovaxID, Presented at ASCO Plenary Session
* First lymphoma vaccine to demonstrate disease-free survival benefit
* Compassionate-use program to soon launch in Europe
Biovest International, Inc. (OTC: BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (OTC: ABPIQ) announced that an eight year pivotal, randomized, multi-center, double-blind, controlled Phase III clinical study has shown that BiovaxID® (personalized therapeutic anti-cancer vaccine) significantly prolonged disease-free survival in follicular non-Hodgkin’s lymphoma. The study, which is being featured at today’s American Society of Clinical Oncology (ASCO) Annual Meeting Plenary Session, found that patients who received BiovaxID experienced a median disease-free survival of 44.2 months compared to 30.6 months for those who received a control vaccine – an increase of 47 percent. In the study, with a median follow-up of 4.7 years, patients receiving BiovaxID experienced a 38% lower risk of disease recurrence compared to patients receiving the control vaccine. BiovaxID is the first ever vaccine targeting lymphoma to demonstrate such a disease-free survival benefit.
BiovaxID is individually manufactured from a tissue biopsy obtained from a patient’s own tumor, and selectively targets only the cancerous B-cells, while sparing healthy cells. BiovaxID is highly specific in its anti-lymphoma attack because the vaccine “trains” the body’s own immune system to recognize as foreign the unique protein (idiotype) expressed only on the cancerous B-cells, thus stimulating and recruiting the patient’s own immune system to destroy the cancer cells and potentially prevent recurrence. In contrast, other existing chemotherapeutic and monoclonal antibody therapies destroy most of the healthy B-cells in addition to the cancerous cells, and may result in serious adverse side-effects. Because the BiovaxID vaccine is comprised of the patient’s own cells (autologous), the therapy has been demonstrated to be safe and well-tolerated.
The final vaccine is administered as a subcutaneous injection along with granulocyte-macrophage colony-stimulating factor (GM-CSF) and keyhole limpet hemocyanin (KLH), which together enhances the potency of the immune response induced by BiovaxID. A previous Phase II study demonstrated that patients receiving the BiovaxID vaccine developed a highly-specific immune response against tumor cells, with 95 percent of patients showing significant T-cell activity against their lymphoma and 75 percent of patients showing a humoral immune response. Furthermore, with a median follow-up of 9.2 years, 45 percent of patients remained in continuous first complete remission with a median disease-free survival of 8 years.
“With this vaccine, we’ve now moved into an era where we can safely use a patient’s immune system to effectively fight follicular lymphoma and enhance the response to conventional chemotherapy,” said Stephen J. Schuster, M.D., Associate Professor at the University of Pennsylvania School of Medicine and the study’s lead author. “Because this vaccine uniquely recruits the patient’s immune system to seek and destroy only tumor B-cells, this approach may be applicable to the treatment of other B-cell lymphomas.”
The completed Phase III study achieved its primary endpoint of prolonging disease-free survival in patients who were vaccinated with at least one injection of BiovaxID as compared to patients who received control. In the study, 177 patients with follicular lymphoma who had achieved a complete response to PACE (prednisone, doxorubicin, cyclophosphamide and etoposide) chemotherapy were randomized to the BiovaxID vaccine (Id-KLH/GM-CSF) or to the control study arm (KLH/GM-CSF). As prospectively identified, investigators analyzed the cohort of 117 randomized patients who, as required by the study protocol, maintained a complete response to chemotherapy for at least six months and who received active (N=76) or control (N=41) vaccine. After a median follow-up of 4.71 years (56.6 months, range: 12.6 - 89.3 months), the median disease-free survival in the BiovaxID arm was 44.2 months compared with 30.6 months in the control arm, which is a clinically and statistically significant difference (p=0.045).
BiovaxID demonstrated a favorable safety profile and was very well-tolerated by patients. Further studies are planned to examine the role of BiovaxID in patients with other B-cell lymphomas such as mantle cell lymphoma, chronic lymphocytic leukemia and multiple myeloma. In addition, new lymphoma studies will evaluate the addition of BiovaxID booster maintenance therapy, which is expected to even further improve survival benefits by maximizing the chance of continuously maintaining complete remissions.
“BiovaxID is a 100% personalized medicine with each vaccine unique to each patient,” stated Biovest’s Chairman and CEO, Francis E. O’Donnell, Jr., M.D. “Despite the failures of other lymphoma vaccines and the skepticism in general towards patient-specific cancer immunotherapies, our unprecedented results presented today are a tribute to the more than 37 years of dedicated vision and labor by researchers dating back to the first mouse studies using this approach in the early 1970s. We congratulate and thank all that have been involved at every level in developing this ultimate targeted therapy, with special recognition to the National Cancer Institute, who with our Biovest team, advanced BiovaxID in human clinical trials. And we also offer our profound thanks to the investigators, and more importantly to the patients that participated in our Phase II and Phase III clinical trials, as their courage in fighting this insidious disease is inspiring. It is only because of their contribution, and with the support of their family and friends, that such potential breakthrough new therapies can be evaluated and ultimately made available to all patients in need.”
In addressing regulatory and commercial plans for BiovaxID, Biovest’s President and General Counsel, Samuel Duffey, commented, “We have already initiated discussions with the FDA and EMEA and are preparing for further meetings with those agencies and other international regulatory authorities in order to share our significant results and determine the most appropriate approval regulatory pathways. In addition, we plan to make BiovaxID available throughout most of Europe on a named-patient basis. This compassionate-use drug access program allows European physicians to prescribe drugs to qualifying patients before approvals are granted, assuming the protocols for each participating country are followed.”
Biovest also reported that the Company expects to publish the final comprehensive results in a peer-reviewed scientific publication later this year.
A Unique Approach to Immunotherapy Targeting B-Cell Blood Cancers
B-cells (a type of white blood cell or lymphocyte) are a vital part of the human immune system, as they produce antibodies that seek out and bind to foreign substances in the body. In lymphoma, as cancerous B-cells develop and multiply unrestrained, each malignant B-cell expresses a unique idiotype or biomarker on the cell’s surface, specific to each patient. Research at Stanford University and the National Cancer Institute led to the development of BiovaxID as a personalized, therapeutic vaccine capable of selectively targeting only cancerous B-cells, while sparing healthy cells. This is achieved by using the idiotype obtained from a sample of the patient’s tumor by biopsy, and through proprietary bioengineering techniques in a patented cell line, a patient-specific vaccine is created that stimulates the immune system by recruiting a patient’s T-cells (immune cells that kill cancerous cells) to seek out and destroy only the diseased B-cells. Unlike other failed cancer vaccine therapies that attempted to target lymphoma, BiovaxID is the only hybridoma (patient’s lymphoma cells are fused to a heteromyeloma cell line to produce the tumor specific idiotype protein) anti-cancer vaccine that consists of a high-fidelity copy of the complete idiotype, believed to be critical in mounting a full and complete immune response against the cancer, as well as “training” the immune system to maintain continuous response if cancerous cells were to return.
ABOUT BIOVAXID®
BiovaxID is a personalized, patient-specific therapeutic vaccine designed to stimulate the patient's own immune system to recognize and destroy cancerous B-cells that may remain in the body or may arise after the patient has been treated with chemotherapy. Unlike many other approaches to treating non-Hodgkin’s lymphoma, BiovaxID is designed to kill only cancerous B-cells, with the initial indication of follicular Non-Hodgkin's lymphoma. Additionally, it is anticipated that BiovaxID could be used to treat other types of B-cell cancers, such as mantle cell lymphoma, chronic lymphocytic leukemia and multiple myeloma.
NAVSTAR TECHNOLOGIES INCORPORATED (OTC: NVSR)
"Up 173.08% in morning trading"
Detailed
Quote: http://www.otcpicks.com/quotes/NVSR.php
NavStar is focused on the creation of GPS products and services that provide wireless tracking of vehicles, equipment, and other valuable and personal assets. The goal is to be a total solutions provider.
NVSR News:
June 1 -
NavStar Technologies, Inc. Signs LOI for Distribution Into Japan
NavStar Makes Significant Entry Into the Mexico Market, Signs an Exclusive Agreement to Sell and Distribute Their GPS Vehicle Tracking System
NavStar Technologies, Inc. (OTC: NVSR) announced it will be partnering with Haengbok Cha to provide asset tracking equipment to Japan. The partnership will include providing equipment, software and related services. The initial focus will be on the NavStar Fleet Management System and will allow owners of commercial and private vehicles to track and monitor the location of their equipment and high value cargo. Service can be as simple as shutting a vehicle down if stolen to providing customized detailed productivity reports. The agreement for hardware and services is expected to generate $2 million in revenue in the first 12 months.
"With the NavStar Fleet Management System, we get a proven product and reliable service. There is a huge opportunity in Japan as market research report 'GPS Market Update' published by RNCOS concludes that Japan has emerged as the leader in purchase of GPS systems with penetration of 44%, followed by the US and European Union. The bulk of these purchasers are eager to make their vehicles an intelligent-transportation system," said Haengbor Cha.
"We are pleased to announce the signing of this distribution LOI with Haengbok Cha and are looking forward to more in depth discussions on exclusivity, a possible joint venture and a direct investment in NavStar. Mr. Cha has extensive distribution capacities and contacts in Japan that would take us years to duplicate. We will focus our initial distribution efforts with Mr. Cha in Japan and have agreed to jointly review other opportunities in the Far East," said N. Douglas Pritt, Chairman & CEO, NavStar Technologies, Inc. "This agreement requires the purchase of a minimum of 10,000 units every 12 months."
UNICO INCORPORATED (OTCBB: UNCO)
"Up 33.86% in morning trading"
Detailed
Quote: http://www.otcpicks.com/quotes/UNCO.php
Unico, Inc. is a publicly traded natural resource company in the precious metals mining sector that is focused on the exploration, development and production of gold, silver, lead, zinc, and copper concentrates at its two mine properties: the Deer Trail Mine and the Silver Bell Mine. The company has also announced agreements to acquire over 70 additional mining claims including the Clyde and Crown Point mining claims. In August 2007, Unico announced that its wholly owned Deer Trail Mining Company subsidiary had completed the purchase of the Deer Trail Mine from Crown Mines, LLC.
UNCO News:
May 28 -
Unico, Inc. Announces Shipment of Concentrate Samples From the Deer Trail Mine for Alternative Processing of Gold and Silver
Unico, Incorporated (OTCBB: UNCO), a natural resource company in the precious metals mining sector, announced that the company has shipped samples of material, including a large bulk sample of flotation concentrate produced at the Deer Trail mill facility in Marysvale, Utah, to Royal Mines And Minerals Corporation for testing of Royal Mines' proprietary technology for the lixiviation of precious metals.
Unico recently announced that it was pursuing alternative processing methods for the extraction of silver and gold from concentrate at the Deer Trail Mine. The purpose of this initiative is to develop the most economical process and achieve the highest recovery of precious metals possible from material produced at the site. The shipment of concentrate and additional material from the Deer Trail Mine to Royal Mines' processing facility in Phoenix, Arizona is one aspect of the Company's plan.
The shipments to Royal Mines, which is publicly traded under the symbol RYMM, began with the delivery of an initial 1 kilogram sample of concentrate produced at the Deer Trail mill facility. After a first round of testing had been completed, three larger samples from the Deer Trail site were delivered, including 45 pounds of screened material from one of the waste dumps at the Deer Trail Mine, a 45-pound sample of oxide tailings from the site, and a one ton sample of sulfide floatation concentrate processed at the Deer Trail mill facility.
Two photographs of the one ton sample that was shipped to Royal Mines have been added to the "Media" section of the Unico website at www.unicomining.com./news/othermedia.php.
Results from the testing of the first sample has led the Company to deliver the three additional samples of screened material, oxide tailings and the one ton shipment of concentrate for further testing by Royal Mines.
"We are pleased to announce the shipment of these concentrate samples to Royal Mines as we pursue the best methods available for the recovery of precious metals from material at the Deer Trail Mine," stated Mark A. Lopez, chief executive officer of Unico, Inc. "The use of Royal Mines processing method is one of the options we are currently considering, and this additional testing will go a long way in determining how the Company may proceed."
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