The BioMedReports.com FDA Calendar database includes over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results.
My FDA Calendar Extreme Trades article series highlights companies with market caps below $1 billion and / or single digit stock prices with pending catalysts in the form of FDA decisions, clinical trial results, and other FDA filings / re-submissions that are expected to have a major percentage impact on the underlying share prices of the affected companies.
Two general Bio-Catalyst Extreme Trading Strategies are outlined below and as with previous installments this article is not an endorsement of the companies profiled or a complete list of extreme trades included in the FDA Calendar database. Please note neither strategy outlined below recommends holding the extreme trade stocks through the actual binary event to mitigate the downside risk; although it is also possible to let some profits ride through the event for a winning position if so inclined.
(1) buying a basket of stocks highlighted in extreme trade reports well ahead of their expected binary events before the trading crowd arrives and causes an increase in the share price and trading volume with a goal of achieving possible returns of 50-100% without the risk of holding through the binary event; and
(2) momentum / day trading strategies for the stocks highlighted in my extreme trade reports in the days / weeks ahead of the expected binary event – taking advantage of the greatly increased stock price volatility and trading volume.
The stock prices for the FDA Calendar Extreme Trade stocks reflect intraday trading on the morning of 10/13/09 at the time of finalizing this report for publication and the companies are presented in alphabetical order by company name. A total of 85 companies are profiled in the extreme trade report today, with the majority of companies trading at below $5 per share, including free samples from the report for 10 companies with recent updates and / or possible near-term catalysts.
Click here for more information on becoming a premium subscriber at BioMedReports.com, which includes access to the full report on the extreme trades in the report today and access to the FDA Calendar database of over 400 entries.
On 7/23/09, Access Pharma (OTC: ACCP.OB) ($3.41) announced that its European partner, SpePharm, is collecting data from a post-approval marketing study of MuGard in head and neck cancer patients undergoing radiation treatment in the UK showing prevention of oral mucositis (OM). In a multi-center study expected to enroll a total of 280 patients, patients are provided with seven weeks of MuGard therapy, and begin using MuGard one week prior to radiation treatment and then throughout the subsequent six weeks of planned therapy. The first 140 patients being treated in this assessment study have been enrolled and treated, and as of the time of the update, none of these patients have experienced any OM.
The encouraging interim results thus far for MuGard in the first 140 patients include some that have completed all seven weeks and others who are still pending completion in the study, and the final numbers for all 280 patients enrolled in the study are expected during early 4Q09. Also, MuGard is being evaluated in about 1,000 patients in Europe (Germany, Italy, U.K.) by SpePharm in multiple post-marketing studies that include 7-week treatment cycles, and a steady stream of data is expected by Access through year-end 2009.
On 7/28/09, Cardium Therapeutics (AMEX: CXM) ($1.94) and its subsidiary Tissue Repair Company provided an update on the completion of their MATRIX Phase 2b clinical study and announced plans to provide detailed safety and efficacy data for their Excellarate product candidate around the end of September. The MATRIX trial, a prospective, randomized, double-blind, placebo-controlled study, has enrolled 124 diabetic patients with non-healing, lower extremity neuropathic ulcers.
The companies also reported that results from the MATRIX clinical study are expected to be used to support additional studies and applications of Tissue Repair's Gene Activated Matrix (GAM) technology for ulcers and other potential applications, including not only the repair of soft tissue injuries such as diabetic or pressure ulcers, but hard tissue injuries such as those affecting bone. On 8/25/09, CXM announced that all patients enrolled in the MATRIX clinical study have now completed their initial 12-week evaluation period. On 10/1/09, CXM announced that it expects to receive the locked unblinded data set and be in position to announce preliminary results on or before 10/14/09.
On 5/27/09, Cytori Therapeutics (NASDAQ: CYTX) ($3.50) announced that it completed enrollment in the first study to investigate adipose derived stem and regenerative cells in chronic heart disease. The trial, which has been named the PRECISE study, was carried out at leading cardiology centers in Europe. It specifically enrolled patients suffering from an advanced form of chronic heart disease, known as chronic myocardial ischemia, for which there is no generally accepted treatment. The trial enrolled 27 patients and was designed as a double-blind, randomized, placebo controlled, dose escalation study. The primary objectives of the study were to assess safety and feasibility of Cytori’s Celution System as part of a novel procedure for chronic heart disease. The Company believes it will be able to fully assess these primary objectives with the data obtained from 27 patients (the protocol allowed for up to 36 patients). Further, the independent data safety and monitoring board had not identified any safety concerns relating to the Celution output or the procedure. Six month results are expected during 1H10.
On 5/28/09, Cytori announced the publication of the first preclinical study to demonstrate ADRCs significantly improved cardiac function after a heart attack. The APOLLO study is the first clinical trial to investigate uncultured adipose-derived stem and regenerative cells in heart attacks in human patients. Enrollment was recently completed in APOLLO, a double blind, placebo controlled, safety and feasibility trial. Data from this study is expected to be reported during 1Q10.
On 9/9/09, Cytori announced its fall medical conference presentation schedule, including the San Antonio Breast Cancer Symposium (December 9-13) presentation of (1) interim, rolling six-month results on patients from the RESTORE-2 study and (2) preclinical data will be presented on the mechanisms by which ADRCs safely enhance fat grafting. Cytori expects to present six-month data for 15-30 patients while final, 12-month data on all patients is expected in early 2011. The ClinicalTrials.gov identifier is NCT00616135 for the RESTORE-2 study, which is a European study designed to evaluate the transplantation of ADRC-enhanced autologous (patient-derived) fat tissue into and around breast deformities. Data from this post-marketing study will also be used to support market adoption and insurance reimbursement for the procedure.
Later this week, data from an investigator-initiated (Dr. Yamamoto, Nagoya University) study evaluating ADRCs for the treatment of stress urinary continence (SUI) is scheduled to be presented at the 7th Annual Meeting of the International Federation for Adipose Therapeutics and Science (IFATs 2009, October 15-17 in Korea). I will upload and share any details or presentation files for this data such as the study abstract after the event if possible. Also, Cytori expects to clarify the FDA medical device regulatory path for the Celution 700 System (e.g. 510k or PMA) early next year.
On 8/31/09, Delcath Systems (NASDAQ:DCTH) ($5.60) announced the FDA granted orphan drug status to doxorubicin, an approved chemotherapy agent, for the treatment of primary liver cancer. The Company said it tested doxorubicin with its unique drug delivery technology, Percutaneous Hepatic Perfusion (PHP), which results in significantly higher doses (e.g. 10X the FDA approved standard dosing with 100X exposure of drug to the tumor site) of anti-cancer drugs such as doxorubicin to the liver without exposing the patient's entire body. Delcath plans to carry out the necessary clinical work for a regulatory submission of PHP with doxorubicin. On 8/25/09, DCTH reported that it has exceeded 90% enrollment for its pivotal Phase 3 Metastatic Melanoma Trial which will enroll a total of 92 patients.
This study is testing the PHP System for the regional delivery of melphalan to the liver to treat patients with metastatic melanoma (a deadly type of skin cancer) who have tumors in the liver, which cannot be removed by surgery (unresectable). On 9/11/09, DCTH reported that the Data and Safety Monitoring Board (DSMB) reviewed clinical data on 77 patients enrolled in its pivotal Phase 3 clinical trial and unanimously recommended that the trial continue to enroll patients with the goal of reaching the 92 patients required to complete the study. DCTH expects enrollment to be completed by mid-October and is still on track for a FDA filing by mid-2010.
On 7/7/08, the FDA accepted for review Hemispherx Biopharma’s (AMEX: HEB) ($1.81) NDA for Ampligen to treat chronic fatigue syndrome (CFS), which was originally submitted in October 2007. The NDA for Ampligen (poly I : poly C12U) is also the first ever accepted for review by the FDA for systemic use of a toll-like receptor therapy to treat any condition and there are currently no FDA-approved treatments for CFS. On 2/18/09, HEB was notified by the FDA that the originally scheduled PDUFA action date was extended by three months to 5/25/09. On 5/22/09, HEB was notified by the FDA that it may require up to one to two additional weeks to take action beyond the scheduled PDUFA action date. However, since that date, no further notification has been received from the FDA.
On 10/9/09, BioMedReports.com conducted an interview with HEB’s CEO, Dr. William Carter for an update on the Ampligen NDA status. Dr. Carter stated that HEB expects to complete a set of preclinical toxicology reports during 4Q09. In addition, the Agency has conducted inspections of manufacturing facilities over the past 12 months which required no corrective actions by HEB. However, the FDA noted certain compliance issues with “fill and finish” facilities and took corrective actions with its own facilities in NJ and is about to complete remediation actions in the next several weeks in the contract lab in WA with a report to the FDA pending. In addition, animal toxicology studies conducted by Lovelace Respiratory Research Institute in NM in support of the Ampligen NDA and at the request of the FDA are currently undergoing auditing and expected to be completed by late 2009 to early 2010.
ImmunoCellular Therapeutics (OTC: IMUC.OB) ($1.08) is developing an off-the-shelf (i.e. does not require obtaining cells from the patient as part of the manufacturing process) peptide-based, cancer stem cell vaccine / immunotherapy (ICT-121) which targets a protein marker called CD133 that is over-expressed on cancer stem cells. The Phase 1 study for ICT-121 will involve 20 patients with glioblastoma (GBM is a deadly type of brain cancer) receiving five treatments each with final data from the trial anticipated after about 18 months (e.g. 3Q11), since the median time to recurrence in GBM patients is only 6.9 months.
ICT-121 may also be beneficial to patients with pancreatic, lung, colon, renal, melanoma, and breast cancers. Early next year (1Q10 which ends 3/31/10), IMUC expects to make an IND filing with the FDA for permission to begin human clinical trials for a Phase 1 study of its off-the-shelf cancer stem cell vaccine candidate (ICT-121). IND Filings for ICT‐121 are expected for Brain Tumors in US or Europe during 1Q10 while IND Filings for ICT‐121 for Pancreatic Cancer are expected in the US or Europe during 3Q10.
IMUC is also developing a Dendritic Cell (DC) Based Cancer Antigen Vaccine (ICT‐107) to Treat Glioblastoma (GBM, the most common / aggressive form of brain cancer). A Phase I GBM trial was initiated in May 2007 with a goal of determining the safety and immune response of patients. The DC vaccine targets six glioma‐specific peptides including targets highly expressed on cancer stem cells. In the study, 19 patients (16 newly diagnosed and 3 recurrent) treated with no serious adverse events and patients received three vaccinations at two weeks apart.
In addition, 43% of newly-diagnosed patients experienced no tumor recurrence with median progression free survival (PFS) of 14.6 months versus just 6.9 months for the standard of care treatment for GBM. Overall PFS in the trial was 12 months while three patients experienced PFS / OS (overall survival) of greater than two years. Initial data was presented earlier this year at ASCO. No grade 3 or 4 toxicities were reported in the Phase 1 trial. The next update on clinical data will be reported at the Congress of Neurological Surgeons on 10/26/09. Potential partnering of ICT‐107 may occur in 2010 as IMUC to fund future clinical development as IMUC retains ICT-121 for in-house clinical development.
VGX-3400 is a proprietary, prophylactic DNA vaccine candidate being developed by Inovio Biomedical (AMEX: INO) ($1.46) to prevent infection with the avian influenza (H5N1). The vaccine is being delivered using Inovio's CELLECTRA DNA Delivery System. The plasmid vaccine is delivered into muscle tissue with the assistance of electroporation with the goal of achieving expression of the H5N1 influenza antigens. Inovio expects to initiate a Phase I clinical trial for this DNA vaccine in Europe before year end and the Company’s clinical team is fulfilling information requests from the FDA relating to its previously-filed IND. Based on my 10/7/09 phone interview with the Company’s investor relations contact, Bernie Hertel, Inovio could potentially receive a FDA response on the IND by year-end and begin a Phase 1 clinical trial for VGX-3400 in humans during 1Q10.
On 10/5/09, Inovio announced interim safety / immunogenicity data from its therapeutic cervical cancer vaccine (VGX-3100) trial. VGX-3100 is a DNA vaccine targeting the E6 and E7 proteins of human papillomavirus (HPV) types 16 and 18 and is delivered via in vivo electroporation. The vaccine was found to be generally safe and well tolerated, and achieved significant cellular and humoral immune responses at the lowest dose administered. This Phase I clinical trial is designed to test the safety and immunogenicity of VGX-3100 in women with a previous history of cervical intraepithelial neoplasia (CIN) 2/3, a precursor lesion prior to the development of cancer.
This dose-escalation study is enrolling patients in three cohorts of six subjects each with DNA vaccine doses at 0.6 mg (0.3 mg each of two DNA plasmids), 2.0 mg, and 6.0 mg. The immunization regimen consists of each subject receiving three immunizations at the indicated dose. The vaccine is delivered using Inovio’s proprietary CELLECTRA intramuscular electroporation delivery device. The VGX-3100 clinical trial is now enrolling the second cohort of six patients. Inovio expects full enrollment of all three cohorts during 1H10 and full analysis of immunogenicity / safety data by 3Q10. In addition, interim results on the second cohort of six patients are expected during 1Q10.
On 9/21/09, Mentor Capital (OTC: MNTR.PK) ($1.55) completed its FY08 audit in preparation for filing a self-registration statement with the SEC and applying to move from the Pink Sheets to begin being quoted on the Over-the-Counter Bulletin Board (OTCBB) system. The move to the OTCBB was accelerated by the Company’s acquisition of a significant interest in Quantum Immunologics (click on preceding link for QI’s News Room page and more details on the clinical trial) in early July, which is a privately held cancer immunotherapy company now in Phase I/II metastatic breast cancer trials.
At year end, Mentor Capital had $1.25 per share in securities or financial assets which included $0.32 or $173,259 in cash against $34,823 in total non-shareholder liabilities along with 546,117 shares outstanding as of 12/31/08. During the year, earnings per basic MNTR share were $0.16. At the close of 2008, 1,386 shareholders held 28,218,840 freely tradable stepped warrants at $1, $3, $5 and $7 per share exercise prices. Upon call and exercise, the eventual expected warrant proceeds calculate to approximately $145 million. In a subsequent event, 83% of the $1 warrant proceeds were pledged to QI in exchange for 20% of the cancer fighting company private stock, with funds primarily being used to finance their FDA trials.
QI originally filed with the FDA for authorization to conduct a Phase I safety trial, but the Agency recommended a combination Phase I/II trial to expedite the clinical development process. Phase I = 3 patients (safety); Phase II = 24 patients (safety and efficacy); patients will receive three OFA-loaded activated DC injections under the skin at monthly intervals to evaluate safety/toxicity, immune response (induction of OFA specific T-lymphocytes), objective clinical responses, time to disease progression, and survival. The Phase I/II trial of QI’s DC immunotherapy that targets OFA-iLRP (oncofetal antigen / immature laminin receptor protein) for Stage IV breast cancer patients is underway with preliminary results expected in January 2010 and final data expected by May 2010.
Momenta Pharma (NASDAQ: MNTA) ($9.50) is partnered with the Sandoz division of Novartis (NVS) to develop a generic equivalent (M-Enoxaparin) of the multi-billion dollar injectable blood thinner Lovenox ($3.9B in worldwide sales for 2008). While MNTA + NVS were not the first to file for a generic version of Lovenox, the 180-day exclusivity period awarded to the first-to-file company already expired on 4/1/09 for Amphastar + partner Watson Pharma (WPI). The other company with a pending ANDA for Lovenox is TEVA, which is also involved in litigation with Sandoz over the Copaxone ANDA.
In late 2007, all three applicants with ANDAs for Lovenox received a request for more information from the FDA on the immunogenicity of their products. 9/26/08 is the date that Sandoz submitted its complete response to the FDA for the abbreviated new drug appplication (ANDA). The Generic Drug Division does not issue decision date deadlines, but MNTA provided guidance in Sept. 2009 for a possible decision on the ANDA by year-end 2009 and believes the Agency has all necessary info to make a decision, including FDA inspections of China heparin sources and a processing plant in Austria that are utilized by Sandoz in the manufacturing process.
On 9/8/09, Protox Therapeutics (TSX: PRX.TO) (OTC: PTXRF.PK) (US$0.58) announced that it has completed patient enrollment in a multi-center, double-blinded, placebo-controlled Phase 2b study (TRIUMPH) of PRX302 in males with moderate to severe benign prostatic hyperplasia (BPH), a common and bothersome urological condition that affects more than 50 million men worldwide. The Company recently provided guidance for reporting top-line results from the TRIUMPH study during 4Q09. TRIUMPH is the third BPH clinical trial of PRX302 conducted by Protox. In addition to being well-tolerated, the previous open-label Phase 2 study reported at the 2009 Annual Meeting of the American Urological Association, showed an 11 point improvement in the International Prostate Symptom Score at the optimal PRX302 dose used in the TRIUMPH study.
PRX302 is the lead drug in the company's PORxin(TM) technology platform. PORxin drugs are pore-forming pro-drugs that are activated by specific proteases produced at elevated levels on the surface of target cells. PRX302 has been generated by engineering the naturally occurring toxin proaerolysin so that it is activated by prostate-specific antigen (PSA), an enzyme that is overproduced in patients suffering from BPH and prostate cancer. Once activated, the drug punches holes in the cells causing the contents to leak out and ultimately cell death.
On 9/10/09, Protox announced positive 12 month data from its open-label Phase 2 study of PRX302 in males with moderate to severe benign prostatic hyperplasia (BPH). The study results indicate that those patients who received an optimal dose of PRX302 continued to demonstrate significant symptomatic relief at 12 months following a single treatment. Detailed 12-month results from this Phase 2 open-label clinical trial will be presented at the 30th World Congress of the Societe Internationale d'Urologie from November 1-5, 2009.
Click here for more information on becoming a premium subscriber at BioMedReports.com, which includes access to the full report on the extreme trades in the report today and access to the FDA Calendar database of over 400 entries.
Below are a dozen major stock price gainers (stock price data current through intraday trading on 10/13/09) from my previous extreme trade article series, which are the reason I prefer investing in a basket of these type of stocks with the hope of picking at least one of the big gainers which can more than offset any inevitable decliners or stocks with flat returns.
Pending FDA Decisions: 20 Extreme Trades – 6/22/09
1.) NeurogesX (NASDAQ:NGSX) was at $5.86, now at $8.11
2.) Salix Pharma (NASDAQ:SLXP) was at $9.91, now at $22.93
3.) Dyax Corp. (NASDAQ:DYAX) was at $2.00, now at $3.38
4.) Somaxon Pharma (NASDAQ:SOMX) was at $1.00, now at $2.29
5.) Human Genome Sciences (NASDAQ:HGSI) was at $2.58, now at $18.70
Pending Clinical Trial Results: Ten Extreme Trades – 5/14/09
6.) Orexigen Therapeutics (NASDAQ:OREX) was at $3.11, now at $8.97
7.) Jazz Pharma (NASDAQ: JAZZ) was at $0.82, now at $7.90
NeurogesX Awaiting Dual Regulatory Decisions – A Dual Extreme Trade on 5/10/09
8.) NeurogesX (NASDAQ: NGSX) was at $2.87, now at $8.14
12 Extreme FDA Trades on New Product Decisions – 4/9/09
9.) Vanda Pharma (NASDAQ: VNDA) was at $0.93, now at $12.30
10.) Hemispherx Biopharma (AMEX: HEB) was at $0.51, now at $1.82
11.) Transcept Pharma (NASDAQ: TSPT) was at $2.85, now at $14.00
Extreme FDA Trades on Pending Medical Device Decisions – 5/25/09
12.) Nephros (OTC: NEPH.OB) was trading at $0.14, now at $1.25
Disclosure: Long ACCP.OB, CYTX, IMUC.OB, INO, MNTA, MNTR.PK, PTXRF.OB.
See my full disclaimer at MikeHavRx.com (bottom of any page).
"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.
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